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What are the 2021 strategic priorities for FDA’s Center for Devices and Radiological Health (CDRH) and what impact will these initiatives have on the medical device industry?

In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues from Vascular Sciences about CDRH’s previous, current, and future strategic priorities, including those impacted by the COVID-19 pandemic.

 

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Some highlights of this episode include:

  • CDRH plans to continue with the same strategic priorities from past years (2018 to 2020). In 2021, some of the most important priorities include: 

    • Finding the right optimal balance between premarket and postmarket data. 

    • Continued development of the FDA CMS Parallel Review Program. 

    • By Dec. 31, 2020, CDRH’s goal is to have more than 50% of manufacturers of novel technologies of novel medical devices for the U.S. market, intend to bring them to the U.S. market first or in parallel with other major markets around the world.

  • Novel technologies are devices defined as a PMA, panel-track supplement, De Novo classification request, HDE, or Premarket Notification 510(k) with the BDP. 

  • Reimbursement is a big deal, if you want a successful product in the marketplace. More companies are realizing the importance of bringing a product onto the market that people can use, buy, or be reimbursed.

  • The pandemic has impacted CDRH’s priorities, resources, and workload. FDA received more than 5,000 EUA device requests, but only 600 have been authorized. 

  • New device submissions for non-COVID related products remain constant, but it’s taking longer to get through the FDA and onto the market. The FDA continues to prioritize responses to COVID.

  • Other new/novel ideas from the FDA include a tracking tool for submissions, finalized COVID-19 guidance documents, and expanding Case for Quality program.

 

Links:

Center for Devices and Radiological Health (CDRH)

2018-2020 CDRH Strategic Priorities

Shuren previews 2021 priorities for CDRH

CDRH Strategic Priorities and Updates

FDA - Medical Devices

Jeff Shuren (Director of CDRH)

FDA - CMS Parallel Review Program

Humanitarian Device Exemption (HDE)

Breakthrough Devices Program (BDP)

Premarket Approval (PMA)

De Novo Classification Request

Premarket Notification 510(k)

Emergency Use Authorization (EUA)

Personal Protective Equipment (PPE)

European Union Medical Device Regulation (EU MDR)

Case for Quality 

Voluntary Manufacturing and Product Quality Pilot Program

Medical Device Innovation Consortium (MDIC)

ISO 13485 - Medical Devices

Mike Drues on LinkedIn

Vascular Sciences

Greenlight Guru YouTube Channel

MedTech True Quality Stories Podcast

Greenlight Guru

 

Memorable quotes from this episode:

“CDRH’s goal is to have more than 50% of manufacturers of novel technologies of novel medical devices for the U.S. market, intend them to bring them to the U.S. market either first or in parallel with other major markets around the world.” Mike Drues

“Addressing reimbursement, especially in the U.S., is a pretty big deal if you want to have a successful product in the marketplace, too.” Jon Speer

“More and more companies are realizing, what’s the good of bringing a product onto the market if people can’t use it because they can’t buy it or pay for it or get reimbursed for it?” Mike Drues

“Some folks have been using this as an excuse to bring devices onto the market that quite frankly shouldn’t and to say things about their device that make certain claims that quite frankly they shouldn’t because they have no basis, no data to support it.” Mike Drues


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