As the FDA closes out FY 2023, it has released the CDRH Annual Report to the public. This report is released every year to highlight accomplishments and focuses for the Center as we transition into the New Year. This blog will summarize the report and highlight key aspects that those in the medical device space should be aware of.
One of the biggest highlights of this year’s Annual Report is the record number of novel devices that have been approved. CDRH’s Director, Jeff Shuren, stated “This was a banner year for the Center, authorizing the highest number of novel devices on record (excluding EUA’s) in CDRH’s more than 40-year history”. In FY 2023, 124 novel devices received marketing authorization, and 167 received breakthrough device designation – of which 29 of those breakthrough devices were granted marketing authorization. This is a testament to CDRH’s commitment to return to “normal” review times post-COVID.
Another highlight from this past year was the expansion of the Total Product Life Cycle Advisory Program (TAP) Pilot. Since its launch, the TAP program has enrolled 15 devices from the Office of Cardiovascular Devices, 10 from the Office of Neurological and Physical Medicine Devices, with more enrollments planned for various other Offices within CDRH. The main objective of the TAP program is to ensure sustainable access to safe, effective, and innovative medical devices by fostering a more collaborative approach to the market authorization process between the FDA and industry stakeholders.
Among other MDUFA V commitments, the Annual Report highlighted the following accomplishments:
- The FDA has exceeded the requirement to provide feedback on applications within 70 calendar days, or within five days prior to a meeting with the agency.
- All 141 CDRH positions that the FDA agreed to fill in FY 2023 have been filled, and the agency is on track to meet its FY 2024 hiring target.
- The FDA has continued to roll out new tools and systems to better assist industry, including updates to the eSTAR template for 510k submissions and more than 150 regulatory science tools.
Overall, the medical device industry should expect a “return to normal” with CDRH doubling down on its efforts to better regulate new and existing devices, and better promote public health. As new industry trends emerge, such as the increase in AI/ML technology, we can expect to see the FDA follow suit and even try to stay ahead of the curve.
Whether you’re an emerging startup with a novel device or an established company with a portfolio of products, EMMA International has a solution to meet your compliance needs. Call us at 248-987-4497 or email info@emmainternational.com to get in touch with our team of experts today.
CDRH (January 2017) CDRH 2023 Annual Report retrieved from: https://www.fda.gov/about-fda/cdrh-reports/cdrh-2023-annual-report
