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Compliance In Focus
Posted by John Lehmann on Thu, May 17, 2012

510(k) Guidelines: Can Everyone Win? Or Does Everyone Lose?

Winners and LosersThe new 510(k) guidelines released by the FDA aim to provide transparency and predictability for companies that are seeking lower-risk device approval through the 510(k) pathway.  Since the initial draft guidance was released, critics have argued that these proposed changes could negatively impact industry, raising the R&D costs to bring a non-significant risk device to market and potentially pushing jobs out of the US as companies strategically look for less cumbersome routes of approval. With the release of the official less cumbersome guidelines, new critics have emerged, stating that the American public ends up the big loser due to the concessions that the FDA made, purportedly as a result of pressures from Congress and industry.

I am curious as to the general consensus out there.  From my perspective as a niche CRO that specializes in GCP monitoring for clinical research trials, the predictability that these changes will offer our clients seems to be positive.  The new classification of Class II devices into Class IIa and Class IIb, with Class IIb requiring clinical data, seems as though it would give companies more predictable guidance as to how they should proceed.  The guidelines don't appear to me to be saying "ok, industry, you win....we'll ask for less."  Instead, they seem to be asking for more, in an effort to ensure safe and effective products for the public, but they are doing so with additional clarity.  Public wins.  Industry wins.  Or not?

I am reaching out to my regulatory colleagues out there to shed some light on this for me!  By making concessions, did the public at large lose?  Are the concessions enough that industry didn't lose?

Photo Credit: b3nda's

Topics: Device Classification, FDA, 510(k)


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