Submitted by kBLASTER Team on
by Mark Hollmer at MassDevice
The FDA pulls 47 draft guidance documents it never made official, covering medical devices, diagnostics, pharmaceuticals and more. The FDA is withdrawing 47 draft guidance documents published before the end of 2013 that it never finalized or acted on. Agency officials posted the announcement in the Federal Register, explaining that the move is designed to boost efficiency and transparency regarding its development of guidance documents.
Trying to determine if a digital health app or wearable is a FDA regulated medical device? kBLASTER® search can help determine the FDA jurisdiction status of your digital health product. Leverage kBLASTER® consulting experience on FDA guidances regarding mobile medical applications, general wellness products and medical device data systems to navigate a path for a non-FDA regulated product.
Looking for the cornerstone to a successful 510(k) clearance strategy? kBLASTER® FDA 510(k) search can quickly identify the best available primary predicate, multiple predicates or reference devices and manage those results effectively.