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FDA Draft Guidance Would Set In Stone Case For Quality Voluntary Improvement Program

 
• By Shawn M. Schmitt

The draft document from the US agency looks to officially recognize a program aimed at advancing quality in medical devices and their manufacturing.

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The US Food and Drug Administration on 5 May released a draft guidance document to officially recognize a program that aims to advance quality in medical devices and their manufacturing.

The 18-page draft, “Fostering Medical Device Improvement: FDA Activities and Engagement with the Voluntary Improvement Program,” carries a date of 6 May. It lays bare, among other things, steps that must be taken to enroll device makers in the program and what the FDA will do with any information it gets

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