Biotech Values

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CDRH open meeting on device approval process, no clear view yet but some sort of toughening of 510(k) process is expected.

Industry and Public Weigh in on 510(k) Process

http://www.healthpointcapital.com/research/2010/02/19/industry_and_public_weigh_in_on_510k_process/

BY LAUREN UZDIENSKI, FEBRUARY 19, 2010

Yesterday the FDA hosted an all-day public hearing to gain feedback on its 510(k) process, looking specifically at issues of predicate devices, new technologies, submission volume and post-market surveillance. The event was webcast and opened to a packed house - in his intro, CDRH director Dr. Jeff Shuren said there were more than 400 people in attendance, plus the web audience - one indication of the attention 510(k) reform is receiving from industry, the media and the public. Shuren added that due to this response, the 510(k) comment period was extended to March 19th (comments can be submitted here).

Dr. Shuren emphasized that the FDA was looking at actions the agency could take in short-term regarding the 510(k) process. He said that the agency would review public comments and the results from a review from its internal working group; send the resulting report out for public comment; decide which recommendations to adopt; and implement these changes before September 30th, well in advance of an IOM study that should be completed in the first half of 2011.

The conversation yesterday highlighted some of the gaps and complexities in the FDA's authority. The first topic to take the stage was substantial equivalence and predicate creep, and this led to perhaps the most detailed, nuanced discussion of the day. FDA representatives outlined the regulatory difficulties for addressing product evolution; for instance, if there's no gold standard, and the FDA requires only that a new device not perform more than 5% worse than a predicate, how do you avoid performance deterioration over time? How do you handle a split predicate (where a device references a separate predicate for device technology and intended use) when the agency's standard clearance method would result in a not substantially equivalent determination? How can we give companies the information that will allow them to select the proper predicate? Solutions revolved around transparency, which would be a recurring theme throughout the day, specifically regarding making redacted 510(k) submissions publicly available.

In the new technologies section, questions about how to conduct rigorous studies were a key component; industry representatives discussed some of the ethical challenges of conducting surgical studies. This was another area where transparency was key, as there appeared to be relative agreement around the need for special controls on certain new technologies, but industry advocated for clear, consistent guidance in these cases. In terms of submission volume, the FDA described such practices as using third-party reviewers to clear submissions. It was not apparent which direction any reform in this arena would take, seeing that current practices were the result of limited resources, but there was a general demand for more consistency.

While these talks were insightful and informative, not much clarity emerged in terms of what the FDA had in mind for the short-term changes to be implemented this year. In that way, yesterday's meeting seemed to be more about getting stakeholders on the same page, as far as how the FDA perceived their own limitations and opportunities, rather than advancing a particular agenda.

For their part, the industry urged caution in reforming the 510(k) process. In a statement released in advance of the meeting, AdvaMed noted that while "there is no process that cannot be improved," the 510(k) has an "enviable 30-year track record of protecting the public health" and that the FDA has "total authority . . . to require whatever evidence is necessary to assure a product's safety and effectiveness."