Final Q-Sub Guidance Describes FDA Meeting Policy
A new final guidance document from the US FDA explains how the agency wants device developers to use its Q-Submission Program to get agency feedback outside the formal product submission process.
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The US agency’s Q-Submission Program provides medical device manufacturers the opportunity to receive information on the regulatory process related to devices in development.
The agency has developed a user-friendly four-step process sponsors can use to address biocompatibility issues based on its 2016 biocompatibility guidance.
The US agency made few changes in finalizing a 13 February guidance document on medical devices made to remove plaque from diseased arteries, but did incorporate manufacturer recommendations on corrosion testing and predicate comparisons.