My Day at FDA

For today's show-and-tell, I'm bringing a picture of me at FDA:

First grade activity and frivolity aside, it was an important meeting for industry, patient advocates, and the agency combined - the Public Meeting on the guidance of when to submit a 510(k) after a device modification.

We heard good points from all speakers:

Patient advocacy groups suggested the 510(k) process should be controlled more tightly by the FDA, including the feeling that the FDA should determine when a modification requires a submission. Advocates cited personal stories (brother who's elbow implant went bad after 4 years), the Institute of Medicine (IOM) report about how the 510(k) process is broken, and how devices as simple as alcohol swabs have initiated massive recalls and even cost the life of a 2-year-old.
Industry suggested that the 1997 guidance is mostly OK and, if anything, the agency just needs to tweak it and provide more detail. Industry representatives presented rationale to show that the '97 guidance meets the intent of the 510(k) regulation, and that many companies use it correctly. Some representatives suggest a greater reliance on design controls documentation (such as V&V results) and risk management could be employed to improve the '97 guidance.
FDA mostly moderated and listened to the speakers and the panel discussion, but they got their own message in as well. They understand the want to use design controls and risk management, but were looking for examples of how to do that successfully. They also talked about other options (such as a tiered risk classification system), but those seemed to be less popular.

The point that struck me was that it seemed that the FDA was asking the question of "how do we implement" and the speakers / panelists - myself included - were answering "what and why we should implement." This opportunity, to comment on and enact change in the regulations that govern our medical device industry, should not be taken lightly. The comment period remains open until July 13th, 2013 and I highly encourage all readers to provide their input and examples (here!). FDA also assured the attendees (and online audience) that any proprietary information will be scrubbed and protected. The FDA needs our help to ensure the future of our regulatory system is safe but efficient. Please do what you can to provide assistance!