The difference between a medical device recall, under FDA regulation, and a product enhancement confuses most regulatory managers. In both cases you are making a change in either the labeling or the device itself or both. The type of change you are making makes a big difference. Recalls have extensive information requirements and interactive oversight by the FDA. The product recall coordinator in the FDA field office and a product manager at the Center for Devices and Radiological Health (CDRH) become involved in your decision-making process. Device enhancements remain under the control of the firm without the required interaction with the FDA. That alone makes a big difference. So, is there a rule of thumb? Are you fixing a problem or making a “new and improved” device? That makes a big difference when it comes to financial outcomes.
The medical device industry often fumbled with what to report and what not to report as a recall to the FDA. The luxury of not reporting a recall ended with the implementation of the Safe Medical Devices Act (SMDA), which generated required Reports of Removals and Corrections submissions to the FDA (21 C.F.R. Part 806). This begs the question of whether or not to report a change you made to the device you market. A “new and improved” product is not reportable. That is a big money maker. A device recall is reportable and costs a lot of money. There is always the temptation to opt for the former.
- Distinguish recall actions from product enhancements
- Who decides the difference between a recall and an enhancement
- CAPA program’s role
- Rule of thumb guidance
- Risk management
- Design controls
- User feedback vs. complaint
- Consumer preferences
- Public disclosure of the change
ex-FDA Expert and former Associate Center Director ,
Casper (Cap) Uldriks owns Encore Insight LLC, which provides consulting services on FDA Law. He brings over 32 years of experience from the FDA. He specialized in the FDA's medical device program as a field investigator, served as a senior manager in the Office of Compliance and as an Associate Center Director for the Center for Devices and Radiological Health. He developed enforcement actions and participated in the implementation of new statutory requirements. He is recognized as an exceptional and energetic speaker. His comments are candid, straightforward and of practical value. He understands how FDA thinks, operates and where it is headed.
Who Should Attend
- Regulatory Affairs Managers
- Complaint coordinators
- Product design engineers
- Product managers
- Sales and Marketing