podcast_S.Niedelman-E.Henry

Are you prepared for the aftermath of the pandemic’s impact on the medical device industry? It may be time for device professionals to start bracing for a new normal.

In this episode of the Global Medical Device Podcast, Jon Speer talks to Steven Niedelman and Eric Henry from King & Spalding LLC about post-pandemic readiness for the medical device industry and how companies can prepare for and embrace the new medical device landscape that’s expected to take shape from 2021 onward.

Steven, a former FDA deputy associate commissioner and COO for the agency’s Office of Regulatory Affairs currently serves alongside Eric as the Quality Systems and Compliance lead consultants in the FDA and Life Sciences practice of their law firm. 

With more than 50 years of combined industry experience between Steven and Eric, the insights and knowledge of this episode’s guests, specifically as it relates to this topic is a MUST listen for any medical device professional.

 

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Some highlights of this episode include:

  • Steven and Eric discuss how COVID is pushing the FDA toward a voluntary pilot program for agency investigators to conduct virtual facility inspections.
  • Steven describes the current state of FDA inspections as challenging to work remotely and conduct follow-ups when appropriate. The FDA has established a paradigm to continue on-site mission critical inspections. 
  • Eric expands on the logistical challenge for inspections by explaining that since the FDA has put a hiatus on its inspection scheme, many organizations are following the Medical Device Single Audit Program (MDSAP).
  • The Medical Device Coordination Group’s (MDCG) 2020-4 Guidance lists four circumstances where organizations under MDSAP or EU notified bodies have remote audits—surveillance, re-certification, change notification, and termination.
  • Impact of the Emergency Use Authorization (EUA) program and the influx of requests on FDA. Some EUA submissions require pre-approval inspections.
  • Before EUAs are revoked, build a remediated QMS, prepare for inspection, and decide whether to continue manufacturing a product after the pandemic.
  • King & Spalding’s FDA and Life Sciences team offers a full-service approach, including cardiologists to help with health assessment risks, premarket and postmarket mergers and acquisitions, and warning letters.
  • Pre-submission is an initial but formal way to build communication, collaboration with the FDA. A pre-submission can be an effective means for understanding regulatory requirements.

 

Links:

Steven Niedelman

Eric Henry

King & Spalding LLC

FDA and Life Sciences practice of King & Spalding

Medical Device Coordination Group Guidance Document — MDCG 2020-4

Pandemic nudging the FDA to launch a voluntary pilot program [...] to conduct facility inspections virtually

Centers for Diseases Control and Prevention (CDC)

Personal Protective Equipment (PPE)

Medical Device Single Audit Program (MDSAP)

European Union (EU) Notified Bodies

Medical Device Coordination Group (MDCG) 2020-4 Guidance

ISO 13485 - Medical Devices

21 CFR 820 - Quality System Regulation

EU MDR

ISO 14971 Medical Devices - Application of Risk

Emergency Use Authorization (EUA)

564A - National Defense Authorization Act 

510(k) Clearance

Premarket Approval (PMA)

2021 State of Medical Device Virtual Summit

Greenlight Guru YouTube Channel

MedTech True Quality Stories Podcast

Greenlight Guru

 

Memorable quotes by Steven Niedelman & Eric Henry:

“As companies think through the fact that FDA has put a pretty big hiatus on their inspection scheme, we also need to keep in mind the medical device industry, in particular, that a lot of organizations are following the MDSAP.” Eric Henry

“There’s a light at the end of the tunnel now that vaccines have been approved.” Steven Niedelman

“We want to make sure firms are ready that at some point these EUAs and 564As might go away. Where does that leave your firm? Have you been collecting data? Have you been working toward establishing the quality system? Or, are you going to decide to just leave the industry?” Steven Niedelman

“Three to four months would be, in an ideal circumstance, after you’ve already done all the work to prepare a submission, have already submitted it, three to four months might get you a 510(k) approval.” Eric Henry


Transcription:

Announcer: Welcome to the Global Medical Device Podcast, where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge direct from some of the world's leading medical device experts and companies.

Jon Speer: We've had quite a few episodes in the Global Medical Device Podcast talking a little bit about COVID and pandemic and impact on the medical device industry. And yeah, this is another one of those episodes for sure. This one's got a little bit of a different take on it. We're talking about post-pandemic readiness. And joining me on this episode of the Global Medical Device Podcast are Steve Niedelman and Eric Henry. These gentlemen are with King& Spalding law firm. They have a ton of experience and expertise on submissions and quality systems and remediation. So this is a really great episode. I know maybe I'm biased. Maybe I say that a lot, but I think this is some really good tips and pointers and advice for folks to think about as they prepare for a post- pandemic medical device world. So enjoy this episode of the Global Medical Device Podcast. Hello, and welcome to the Global Medical Device Podcast. This is your Host and Founder at Greenlight Guru Jon Speer. And again, folks, there's a lot going on in the world. Hopefully you're all being safe and sound. There's been a lot of impact on the medical device industry with respect to the pandemic and COVID-19, and we've got a couple of experts joining us today from King & Spalding. And we're going to talk a little bit about post-pandemic readiness. And joining me is Steve Niedelman. Steve serves as the lead quality systems and compliance consultant to the FDA and Life Sciences practice team at King & Spalding specializing in regulatory enforcement and policy matters involving industries regulated by the U. S. FDA where he provides strategic advice, insight, and guidance to the medical device, pharmaceutical, biologics, tobacco and food industries. Mr. Niedelman retired from FDA after a 34 year distinguished career where he served as Deputy Associate Commissioner for Regulatory Affairs and as Chief Operating Officer of the Office of Regulatory Affairs. He also served as the Director and Deputy Director of FDA's Office of Enforcement, where he also presided as chairman in FDA's Compliance Policy Council. Before joining the office of enforcement, Mr. Niedelman spent nearly 24 years throughout the Office of Compliance at the Center for Devices and Radiological Health. He has also served as Vice President of the FDA Alumni Association twice as a member of the Medical Device Committee at the Food and Drug Law Institute. And as a member of the Editorial Review Board for Medical Device Summit and FDA News, GMP Publications directed at the pharmaceutical medical devices industry. Also joining from KinG& Spalding is a colleague of Steve's is Eric Henry. Eric is a senior quality systems and compliance advisor in the FDA and Life Sciences practice of the law firm King & Spalding. Eric has 30 years of global leadership and practitioner experience in a variety of quality compliance and practice development roles with a specialization in large organizational change and remediation programs, software quality, including cybersecurity, medical device design controls, risk management, audit management, and management controls. Prior to joining King& Spalding, Eric led global technical and quality organizations at Philips Medtronic, GE Healthcare, Boston Scientific, and Hologic. So gentlemen, a quiet distinguished career for each of you, and I'm really honored that you are both joining me today. So welcome to the Global Medical Device Podcast.

Steve Niedelman: Thanks for having us. Thank you, Jon.

Eric Henry: Just great to be here.

Jon Speer: Now, I saw an article that each of you contributed to talking a little bit about a pilot program for virtual inspections for FDA in med device. And that triggered me to reach out and I'm like, " I want to learn a little bit more about what's going on." And when we had that first conversation both of you highlighted, " Hey, there's a lot of things that we as an industry need to be doing to prepare for a post- pandemic world." What we used to be, but when we get out of that post- pandemic and might not be the way it was before the pandemic. So I thought we could explore that a little bit, but Steve, I was wondering if you could share a little bit about the current state of FDA inspections, because I got to imagine this has been a really challenging area for FDA in recent months.

Steve Niedelman: Yeah, it has Jon. Most of, if not all of FDA investigators and all of FDA are still working remotely themselves and it has been challenging. It's been challenging to conduct followups where appropriate, et cetera. Back in July of 2020, FDA did announce that they would begin... they established a paradigm for continuing inspections, onsite inspections throughout the country. Some inspections probably less than 5% have resumed since July 20th. Clearly their focus is going to be mission critical. They're not going to be typical surveillance inspections. They're going to be inspections where the agency is determined that they are mission critical. They do have where they are significant public health issues, where there may be significant or serious complaints that have been brought to their attention, perhaps pre-approval inspections, especially if they are pandemic related to verify the validity of data to support submissions. The agency has pretty much left that latitude open for themselves. They will prioritize when they get back into normal course of business. Those that will be compliant follow- up inspections will probably get the priority first, as well as any pending pre- approval inspections where applications have been held up. As I said, they have established a paradigm that basically ties the activity of the pandemic in a particular local areas. They took the entire country, subdivided it into counties. And depending upon whether your County is red, green, or yellow, FDA will determine whether or not they feel comfortable sending an investigator who also needs to come from either a red, green or yellow County and to do an inspection. And obviously green needs to be green for the safety of the investigator, as well as the safety of the inspected firm. And you can expect that all there will be a questionnaire in advance of that as well, to make sure that there are appropriate mitigations in place that you affirm that your firm is operating and not everybody is remote. And that you can expect that full PPE will be expected in accordance with CDC guidelines.

Jon Speer: Wow. That sounds like quite a logistical challenge. Eric, any other thoughts on the inspection side of things?

Eric Henry: Yeah, I would just say that as companies think through the fact that FDA has put a pretty big hiatus on their inspection scheme, we also need to keep in mind the medical device industry in particular that a lot of organizations are following the MDSAP or the Medical Device Single Audit Program scheme. And those notified bodies that are using that, that are auditing to the MDSAP program, they've been doing remote audits for quite some time now through the COVID-19 pandemic. In fact, the Medical Device Consortium Group that does guidances for the EU and a lot of notified bodies will follow their guidance, even outside the EU jurisdiction. They've published a guidance, it's called 2020-4, where they list four different circumstances where organizations under MDSAP or under a notified body jurisdiction can have remote audits with no surveillance audits, recertification, notifications, and then if you're changing notified bodies. And I mentioned that here with relative to the FDA, because as many folks who are in the MDSAP program know the FDA has advocated the inspection program that they normally would pursue for companies to the MDSAP program, especially if in the cases of routine inspections. So even if you don't get an FDA inspection, you may still be getting those MDSAP audits and the FDA would then use the results of that to drive further action on their part.

Jon Speer: I know the MDSAP program has been gaining in popularity here in the United States. And folks will provide a link to a 2020-4 document that Eric referenced in the text that accompanies the podcast. But I assume though that even if the inspection is virtual through this program, it still, holds buster with FDA.

Eric Henry: Yeah. I mean, absolutely the MDSAP program results would still be considered adequate for routine inspections. Again, there's a lot of circumstances where the FDA would not accept those results for cause inspections, pre- market inspections and things of that nature. But as far as I've seen so far, there's no indication the FDA would stop accepting MDSAP audit results in lieu of routine inspections, just because they're remote.

Steve Niedelman: Yeah. Can I just put-

Jon Speer: Yeah. For sure.

Steve Niedelman: ...a thought to that is, keep in mind the EU and Great Britain, they're not part of the MDSAP program and they are conducting... I've had conversations with them HRA and others. They are conducting virtual audits. What do you want to call a remote audit, so virtual audits. They continue to be ongoing in Europe. And so you're notified body inspections you can expect will continue as well as the MDSAP orders.

Jon Speer: Yeah. Greenlight Guru, we've had quite a few customers actually who are in the ISO 13485 certification going through it, or going through the surveillance or what have you. So quite a few of our customers have been going through those remote virtual audits as well. So it does seem to be a thing. Steve, I was talking to a colleague yesterday or recently, or actually had an acquaintance, I guess we don't work at the same company, but I've known him for many years and we were chatting a little bit about the impact EUA has had on FDA. Now, I know the review side and the inspection side are different parts of the house, different sides of the house and FDA. But I think he said something like there had been like 5,000 EUA submissions sent to the FDA and something like 600 of them had been granted and that sort of thing. But you mentioned a moment ago that some of the EUAs that are being submitted require pre-approval inspection before they're able to go forward. So, I got to imagine just the whole EUA process is, it's not new per se, but at least in my lifetime, I don't recall a time where EUA has been so popular and prevalent. This has probably created a lot of noise across all parts of FDA.

Steve Niedelman: Yeah. There were two authorizations that FDA uses under their authority under Section 564 the Act, one is for emergency authorizations, your EUAs. And these authorize firms to manufacture and distribute unapproved products to address the the declaration of emergency that was declared by the Secretary. EUAs have been very widely used as you know there have been quite a number of applications. And I believe the agency has approved, like you indicated over 500. Many of them were for PPE because initially everybody was caught short with with N95 masks. And now the protective gear, and we're being manufactured by manual and was able to substitute those masks that were similar to the kind that FDA would expect and have cleared as class two devices as alternate and has subsequently enhanced that list of firms that are now manufacturing KN95 masks and other masks that can be used in suitable situations. And so a lot of them were PPE oriented. A lot of them though were also for in vitro diagnostics, which we can't forget our medical devices. And these are the not only the diagnostics for diagnosing COVID. One of which was just approved yesterday for home use, for example that you will be able to buy in the pharmacy without a prescription. But other side of it, as well is obviously detection ability, whether it be a rapid detection test or the full blown evaluation that takes a little bit longer. So there's been a lot of use of EUAs. The other side of authorizations or what they call 564A authorizations, and that enables a firm to manufacture an approved device than otherwise clear device that does not have a full blown quality system in place, such as for example, those situations where a manufacturer needed to enhance its manufacturing capacity by engaging another unrelated firm that was not typically a medical device manufacturer to manufacturer and enhance the ability of meeting the demand. And those firms, while they had to provide some level of a quality system, they weren't quality system compliant. And these are the concerns that Eric and I have going forward because at some point there's a light at the end of the tunnel now that vaccines have been approved, and we want to make sure firms are ready that at some point, these EUAs and 564As might go away. And where does that leave your firm? Have been collecting that? Have you been working towards establishing a quality system, or are you going to decide to just leave the industry?

Jon Speer: Yeah. And let me unpack some of that a little bit more. So an example, I think of a 564A, I guess you can confirm if I'm thinking the right thing like ventilators, there were some early on in the pandemic some automotive manufacturers that were jumping in to help and they had the capacity to manufacture ventilators. I'm guessing that that automotive company, it would be an example of a 564A?

Steve Niedelman: Yeah. That was what they used the Defense Authorization Act for that.

Jon Speer: Okay.

Steve Niedelman: But yeah, that would be a good example if it wasn't authorized through that act. Obviously Ford Motor Company doesn't have, or Tesla doesn't have the medical device quality system in accordance with 21 CFR Part 820, but there are equivalent quality systems that are used in the automotive industry that at least provided an equivalent overview capability to have a quality system in place to conduct investigations, have campus systems, et cetera. So those were the type of authorizations that the FDA is facing as well.

Jon Speer: Okay. Terrific. And to your point, I also share some of your concern. I know we've had quite a few folks reach out to us who are jumping into the EUA phrase, so to speak and they're not med device companies. They never have been. And in some cases I think they're... I'm not sure if their interests... well, we'll leave that aside. But for those who do have an interest in and altruism is at play here where they have capabilities, technologies, et cetera, and they're jumping into the EUA process and becoming a medical device. We're trying to say, hey folks, you've got to build this quality system. You've got to be prepared because one day, none of us are going to know exactly when we're going to be out of this pandemic. And you can't just keep that EUA clear device on the market without taking the necessary provisions. So Eric, maybe elaborate on some planning and some next steps for folks that might be in that position.

Eric Henry: Yeah. It's a really good point, Jon. We work with clients all the time that are either new to this space or getting into this space as a result of the COVID crisis. And there's really three big elements that we have to focus people's attention on. One of them is easy to build a remediating at QMS, right? And if you're going to build a remediate QMS, we help them. And even if you don't get external help, find some internal resources to put a good plan together for that program where you're doing things like gap analysis, looking at how you fill those gaps, prioritizing those quality system elements according to the level of risk and obviously safety risk being one of the primary components of risk assessment, but also business risk and compliance risk and other things. But put that program together, put a schedule to it. And then prepare for the ventral inspection, right? At some point, these are going to resume. And so whether it's just routine inspections that are going to pick up or for cause, or things related to new products that you have in the market. And that'll particularly be the case, if the third item that we have people looking at comes to pass, which is you decide that after this crisis is over, you're going to continue to manufacture that product. So in the cases, especially as you mentioned, automotive companies doing some manufacturing, if they decide they want to keep doing that, for instance and they want to keep manufacturing that, and maybe even want to start know some of these companies that decide, hey, you know, we like being in the medical device business, we're going to start up some medical device practice and business unit of our own and keep that that going. Well, now's the time to be collecting data and doing the work that you need to support a submission for clearance or approval of that product. Don't wait until this is over. In fact, these EUAs are only good as long as the FDA says they are, and they're not required to provide notice before putting out a statement that these EUAs are canceled. Now they've agreed based on the press, we've read so far that they are going to provide notice. So once they do our guests right now is you're looking at maybe three to four months after that notice that you'll have time to either get that submission ready, get it in place. Maybe even pre- empty that notice with your own submission so that you won't have any interruption in manufacturing, but in the case, but if you're going to do that, you have to have a quality system built to remediate it to support that as well. So those three components are huge. As people get ready to come out of this, build a remediate, the QMS, get ready for that inspection. There's a lot of inspection prep ups, things that people that have never been in this industry aren't even prepared for at this point in terms of staffing process, infrastructure, tools. And obviously doing dry runs to make those inspections go smoothly, and probably getting some outside help either as contractors or staff or consultants to be able to help them through that process. So, it's a much bigger deal than I think is, as you stated, companies are anticipating right now once the EUAs are up.

Jon Speer: Yeah. And you said that when FDA says we're not doing this anymore. We're revoking. I don't know if that's the right word, but for now I think that it gets the context revoking the EUAs, but you'll have a three to four month window if companies are thinking, oh, we'll just wait until that, that happens a few months. It's plenty of time. It's probably not. So I think your words of advice, Eric are words that folks that are in that EUA position, especially those who are new to med device, but even those who have EUAs and they are med device companies should heed, I mean, three to four months that that's may not be enough time to prepare everything that you need to. So now that's the time to start preparing for that so that you're in a good position-

Eric Henry: So Jon, three to four months would be in an ideal circumstance after you've already done all the work to prepare submission, have already submitted it, three to four months might get you a 510(k) approval.

Jon Speer: Right.

Eric Henry: But knowing there's going to be this massive influx of submissions around that time and realizing too, that you'll have to build everything to support that submission and the inspections and the quality system reviews that will accompany it, you need way more than that. And you should have already been well underway by the time application is given.

Jon Speer: That's a really good point. So when we say three to four months, that means that you have to have 510K clearance or a PMA approval or whatever the case may be in that period of time, not just submitting those regulatory submissions, correct?

Eric Henry: Right.

Jon Speer: Yeah. Wow. Okay. Yeah. So folks, in my experience, a 510(k), I mean, there's statistics from FDA on this and current statistics are skewed a little bit because of the pull that EUA has had on FDA reviewers, but a typical 510(k), you can expect it to take several months to go through the process all by itself. So if you're waiting to that time to prepare your submission, it's too late, it's just too late.

Steve Niedelman: We don't know exactly how they're going to spin this, but there could be a possibility especially perhaps for lower risk 510(k) devices that by the end of the three or four months, you need to have a submission into the agency. So we need to be prepared for both options. One of which having your device cleared versus you need to have that submission in, at the date that the EUA or 564A is terminated.

Jon Speer: Right.

Steve Niedelman: We don't know yet what they're going to say, but it's going to place a tremendous onus on them as well, resource wise. And so we don't know what they're going to say-

Jon Speer: Sure.

Steve Niedelman: ... butyou need to be prepared for the option that Eric has defined.

Jon Speer: All right. Well, folks, let me take a brief pause and remind you that I'm talking with Steve Niedelman and Eric Henry. Both gentlemen are with King & Spalding and part of their FDA and Life Sciences practice. Steve, do you mind elaborating a little bit more about King & Spalding, and then I'm familiar with your firm. I think probably many folks who are in the medical device industry are probably familiar with your firm, but I guess elaborate a little bit on the types of services and ways that you help companies with their medical device practice and needs.

Steve Niedelman: Oh, thanks, Jon. King & Spalding has enormous depth in the FDA and Life Science arena. While Eric and I are consultants, and we have others as well including a world renowned cardiologist to assess with health risks. We have pre- market consultants. We are obviously not attorneys in this law firm. Most of our colleagues are, and our colleagues who are attorneys have a tremendous amount of depth in assisting firms in all aspects of FDA and Medicare, Medicaid requirements. We assist in the pre- market arena, post- market arena. We assist with mergers and acquisitions. We assist with obviously warning letters and junctions, responding to untitled letters, assisting with FDA behavioral issues. We really provide a full service approach to everything that can affect any manufacturer of any FDA regulated industry, whether it be a medical device, pharmaceutical combination product, biologics vaccine with the vaccine development as well. And tobacco industries, food industries, imports, we really provide a full service, the amount of depth, the ability to say that we are from the FDA attorneys from the Office of Chief Counsel help enormously with just as people like myself are very familiar with FDA's expectations, FDA's verbiage, knowing what FDA is looking for is really very helpful as we assist firms with compliance plans assisting in the enforcement issues, compliance issues. Or proactively assisting them in ensuring that they're which we always hope is the best approach that their quality systems are appropriate and that they can get their 510Ks through PMAs, et cetera.

Jon Speer: All right. Thank you for elaborating that. And folks, I'm going to remind you to Greenlight Guru. We're also here to help. Greenlight Guru has the only medical device quality management system software platform on the market. Today, it's been designed specifically and exclusively for medical device companies. So 21 CFR Part 820, ISO 13485, EU MDR, ISO 14971, 21 CFR Part 11. All of those things are pre-baked if you will, into our software platform and our product offerings, so that we're trying to make this as simple as it can be, keep the guardrails in place so that you know how to navigate establishing your quality system in a way that allows you to meet the intent and comply with the applicable regulations and streamlining those workflows for you and your team. So we have workflows for managing design controls, risk, document management, change management, and quality events, things like cap as in complaints and nonconformances and audits. So I would encourage you to check out www.greenlight.guru to learn a lot more about the software platform. And if you're interested in learning more about how we might be able to help request a demo, and we would love to have a conversation with you and see if we might have some products and services that can help you with your needs. So again, go to www.greenlight.guru to learn more. All right, getting back to the conversation, I've heard this a couple of times now recently, and it was a little bit of a head- scratcher the first time I heard it. I thought maybe the person misspoke, but the pre- submission has been a very popular program. In fact, I encourage a lot of medical... just about every medical device company go through a pre- submission because it's a great way to build a rapport with FDA, but also just have an exchange and collaboration and communication with FDA. But I heard a couple of times, like I said recently where pre- submissions have been rejected and I was like, "What is going on?" So do either of you have any color about that?

Steve Niedelman: I have to admit I am not a pre- market guy.

Jon Speer: Okay.

Steve Niedelman: We do have that expertise so it's not really within my wheelhouse. I do know that pre- subs are the way to go. Pre- subs these are the best way to get the benefit of the agency's thinking before you go too far down the road only to find you went down the wrong path, but I have to be honest I would be remiss if I try to portray it as I had any current understanding of the current status of requests.

Eric Henry: And I don't have any statistical evidence to support what you're saying, Jon, but anecdotally, what I can tell you is that those pre-sub meetings have been ongoing, but I have heard of some firms where they've had or had significant delays in the pre-sub meetings where they've had to cancel them and the FDA has just proposed for them to move forward and go ahead and let the FDA go through the review process. And primarily, the reasons given were twofold. Number one is even indicated earlier, there's a tremendous resource constraint right now as companies are... the number of companies in this space has now mushroomed as well as the number of changed or new products that are being considered for submission are also getting much larger. But also where in the medical device and pharma space, especially within FDA, it's kind of all hands- on deck with COVID work. And so some resources that may have been used for pre- sub meetings are being pulled to do other things, and aren't available for that. So that further constraints, the resources that a firm may have access to at the FDA. I will just as a side note here, and just because this is a topic that comes up in pre sub meetings a lot, and Jon, if you're helping companies with pre- subs, I'm sure you give the same advice, these pre- sub meetings, although they are absolutely the way to go and in a way to make sure that you're going down the right track before you've gone too far, these are not informal discussions with the FDA.

Jon Speer: Right.

Eric Henry: And where you can get those pre- sub meetings executed, and this is just sort of for what it's worth piece of advice while we're on that topic. There's no such thing as an off the mark, off the record conversation during these pre- sub or Qsub sessions. So be prepared for them, put the agenda together, do the work, have the right people in the room and realize that everything that you say and everything that they say will be part of an official record.

Jon Speer: Yes.

Eric Henry: And you should approach the meeting in that context.

Jon Speer: For sure. This is not just pick up the phone and call somebody at FDA and say, hey, let's have a conversation. There is preparation that's involved. And while the feedback that you get from FDA is technically non-binding, it is a good insight into the FDA's thinking on your particular product and space. But it is formal. It is a really good point. And I guess kind of talking about submissions a little bit further, I mentioned a moment ago that there's been thousands of EUAs that have been submitted to FDA. And to your point, Eric, it's all hands-on-deck. So that's been the priority and the focus. Obviously there's been a downstream impact on non EUA types of submissions. I think I've heard there've been some significant delays there. And Eric, you mentioned a moment ago that at some point in time, FDA is going to say, all right, we're no longer in a pandemic status here. We're going to stop the EUAs where companies got to prepare their submission and get in early, get prepared. So anything more that you think is really important and as far as pragmatic tips and pointers and advice for folks on the submission side of things.

Eric Henry: Yeah. I'm sure Steve will echo this. He and I've had a few offline conversations about this, but just collect that supporting data now that you're going to use to support future clearances and approvals, and also file those as soon as possible. Again, don't wait for the anticipating a potential heads up from the FDA in time enough to be able to get your submission in and expect that to be reviewed, even though there are obviously, what's part of the do for their, there are deadlines that the FDA puts on itself to try to get these things done and get these things reviewed. I can't expect with the huge influx of submissions that are going to be coming at the last minute from firms that are unprepared, that they'll be able to meet all of those as they would like. So if you can at all, get what you need to do a submission before the end has been announced. So the EUAs and these QMS exemptions do it. And the last thing I would say, and this may seem like an obvious one, but I know a lot of companies aren't yet there yet make sure that you've got your registration and listing in and up to date for your firm and for your site, because if that's not right, that's going to cause problems with both your submission and any subsequent inspections.

Steve Niedelman: Let me just put some context, because there's been a lot of good dialogue from Eric and yourself as well, Jon. First of all, everybody should realize during an inspection or during a pre- sub meeting or any dialogue with FDA, nothing is off the record. So be mindful of that. People will try to befriend you, et cetera so just keep in mind, nothing is off the record and you should always be aware of that. It will be Memorial. Your conversations will be memorialized in some form, if it has any kind of relevance at all. And when you're preparing for a meeting with FDA, as Eric indicated, get your most important message out upfront as early on in the meeting as you can, because these meetings are generally tying down, and before you know it, you'll go off on a tangent, there'll be questions that are raised. And the most important issue you want to get to is at the end of your presentation and out at the beginning. So get the big ticket items dealt with upfront to make sure that the end of the day, when you walk away from that meeting, you have the answer to the most difficult situation that you need to deal with so that you make sure that you're on the right track. And to Eric's point, if you're ready to submit a 510(k) now, get it in now. It's been on FDA's books, not on yours, and it will help in the long run. And it'll also get you earlier on in the queue of getting these things cleared. All the resources right now are primarily focused on COVID. So it doesn't hurt to get them in if you're intending to stay in the industry or getting the product, if it's not already cleared to be cleared.

Jon Speer: Steve, I think that's such a good tip about getting your key concern or question or message out at the front end, because like a pre-sub meeting, I think if I recall, I could be off a little bit, but it's like an hour. You don't grab a lot of time. And I've worked with some companies who are preparing a pre-submission and they have a hundred slides on their slide deck, I'm like, " You're not going to get through that."

Eric Henry: No way. That's right.

Jon Speer: No way.

Steve Niedelman: Don't spend a lot of time on your firm's history on all your other products. Don't spend your time crosstalk-

Jon Speer: Get to the point.

Steve Niedelman: Get to your point early on, because for these meetings have a tendency to go walk on a tangent. Somebody will raise a question before you know it, you didn't even get to the third slide.

Jon Speer: Yeah.

Eric Henry: And then the problem you end up with, right, is that as we talked about previously with the FDA being as resource constraint is they are getting the meetings on their calendar can seem like you've won the lottery. And the last thing you want is at the end of that, you haven't gotten the viewpoint from the FDA on the real issue that was concerning you the most. And now you're trying to reschedule, and you just have to roll the dice all over again, to see if you can even get on the calendar to get another pre- sub meeting scheduled. And frankly, I've heard FDA folks on the phone with some of these pre- sub meetings when you end it with a whimper and you haven't gotten everything out of it, you wanted and you try to reschedule, they start to get a little impatient, right? Because their time's valuable, your time is valuable and you don't have time to waste on chit chat.

Jon Speer: Yeah, absolutely. Absolutely. Gentlemen, as we wrap up the conversation today on post- pandemic readiness, are there any other tips, pointers things you want to highlight or reemphasize before we wrap things up today?

Eric Henry: Let me just speak to one thing that people may or may not be considering, but I know is very important, especially for those that may be new to this industry, and that's people. Think about the staffing needs that you're going to need post pandemic, right? In the quality space, look at production quality, design quality, supplier quality, software quality, internal audit, doc control, all those different things. Post- market surveillance, risk management. And you may have a few people, if you're a small firm that can wear multiple hats, but you need to make sure that all of these roles are accounted for in your organization to support the quality system that you're going to have to either build or remediate to support either new products or an expanded array of products to handle the post-pandemic world you're going to live in. And I would also say that because these inspections will resume at some point in person, if you're not accustomed to that kind of interaction with the FDA, you need to do these mock inspections as much as you can, practice, practice, practice, and make sure that you have the people in place to support that those front room folks, the scribes, the back room folks, subject matter experts, quality reviewers, all those people need to be in place and whatever tools and processes and mechanisms you're going to use to support those. Those are all things that you'll need to do to prepare. And again, you should be doing that now so that when these inspections resume you aren't trying to figure it out as you go along. And I think it really does boil down both in terms of executing the QMS and preparing for inspection, having these roles defined and having people identified and prepared to assume them post pandemic.

Steve Niedelman: Yeah. I'd like to add to that if I could that, if you're currently in the medical device industry, you may have been manufacturing other products pre-pandemic, and you've now introduced new products, make sure the procedures and policies in place are being followed for the new product. Do a gap analysis. Assure that the guys, the people that are making a new product are really following what you've said you have in place for the rest of your firm. If you're new to the medical advice industry, and you have another quality system, you really should, as well as Eric said, do a gap analysis, put procedures in place to make sure you're compliant with 21 CFR Part 820, because at the end of the day, that's the expectation. The freebie is going to go away at some point. Make sure you have the right people in place, and make sure as all of you guys are aware, those would be when the medical device industry management controls are critical to the success of your quality system, make sure you have the right people in place. Make sure as Eric said, people may wear multiple hats, just make sure the person who's head of ops is not also the head of quality, because there's a natural conflict there. You need somebody in quality to just say no. And they have to play that role of oversight. So you really need to conduct these mock audits. I know we currently do them for other firms. We do them for our clients. We routinely do them, others do it as well. But it's really good practice for you to get into conduct that and make sure your inspection ready at the end of the day, get those applications and/ or collecting data to support your product. And hopefully, we all want everybody to be successful at the end of the day.

Jon Speer: Gentlemen, thank you so much. And certainly folks heed the advice that Steve and Eric are provided or have provided throughout this conversation, and if you'd like to learn more about how King & Spalding can be a resource to help you with all of the things that we've talked about, I would encourage you to reach out to them. A website's pretty easy, www.kslaw.com, kslaw.com. And certainly you can reach out to Eric, and Steve, and they'd be happy to provide or connect you with the right resources to help you navigate these processes being inspection ready, making sure you're doing the right thing from the submission standpoint. Again, Steve Niedelman, Eric Henry, King & Spalding, gentlemen, thank you so much for being guests on the Global Medical Device Podcast.

Steve Niedelman: Thank you, Jon, and happy holidays to everybody.

Eric Henry: Yeah, absolutely. Thanks.

Jon Speer: And as I've mentioned before, Greenlight Guru, we're here to help you as well. We have the only medical device quality management system software platform on the market, it helps improve your efficiency. In the case of remote audits, we have customers who are going through that each and every week now. So certainly, as your remote and virtual, it's certainly a resource to help you. And even in normal times, it's a resource to help you. So be sure to go check out wwww.greenlight.guru to learn more. As always, this is your Host and Founder at Greenlight Guru, Jon Speer, and you have been listening to the number one podcast in the medical device industry, the Global Medical Device Podcast. Thank you. Continue to spread the word to your friends and colleagues, and we'll catch up with you again real soon.


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The Global Medical Device Podcast powered by Greenlight Guru is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.

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