Regulatory Tips & Observations

What are some recent trends and observations in the medical device industry regarding regulatory affairs and strategies?

On today’s episode, we have Allison Komiyama of Acknowledge Regulatory Strategies and former FDA reviewer, offering us with a very unique perspective on this topic.

Allison is currently a consultant who helps companies with regulatory strategies and submissions, and patient of life-saving medical devices.

 

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Some of the highlights of the show include:

● The regulatory path to get devices approved has been under scrutiny for decades. Companies may think it’s too hard or cut corners with FDA regulations.

● Get a second opinion, conduct research, and ask questions about medical devices because your or your loved one’s life may depend on the device.

● FDA reviewers may go into industry because they know how to regulate devices. They understand why regulations are in place to make devices safe, effective.

● If a company does testing, gives the FDA what it needs, and participates in the pre-submission process, the likelihood of a device being approved is greater.

● When preparing regulatory documents, review information available on the FDA’s Website and contact DICE and/or regulatory consultant.

● Consider pre-submission if your company isn’t confident about testing needed or is an early startup that needs guidance on its regulator strategy.

● AI Letter: Puts your device submission on hold for issues and deficiencies that need to be addressed within 180 days. Avoid getting an NSE letter!

● Update your 510(k) summary if a predicate device has been subject to a recall. FDA wants to make sure the new device does not have the same issues.

 

Links:

Acknowledge Regulatory Strategies

Acknowledge Regulatory Strategies Blog

The Bleeding Edge: Lessons Learned for the Medical Device Industry

FDA 510(k) Submission Process

FDA Premarket Approval

FDA Medical Devices

Division of Industry and Consumer Education (Dice)

Refuse to Accept Policy for 510(k)s

Not Substantially Equivalent FAQs

Michael Drues

Greenlight Guru

 

Quotes:

“Ask questions. Don’t be shy to be an advocate for yourself. Don’t (just) trust doctors or FDA. Trust yourself, as well, and do your own research.”

“I do feel very strongly that FDA reviewers have the best interest of the patients in mind.”

“I’m glad that I know the other side of what goes into getting this device onto the market. There’s a lot that goes into these devices before they’re allowed to be used on patients.”


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