R&Q's Blog

Medical device industry news and trends - and the resources to understand and act on them.

 

Acceptance and Filing Reviews for Premarket Approval Applications (PMAs)

In addition to the Refuse to Accept Policy for 510(k)s Guidance document I discussed in my previous post, the FDA also issued a guidance titled Acceptance and Filing Reviews for Premarket Approval Applications (PMAs) at the same time.

Creating Consistency

One major variable med tech companies are faced with today is the unknown of FDA reviewers. It seems like what works for one company doesn’t necessarily work for the rest. And why is this so?

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