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News, FDA, 510(k) submission, regulatory news, compliance, 510(k)

What You Should Do About the Two New FDA Draft Guidance Documents

It has been a long journey for the FDA to get the new draft guidances..


510(k) submission, 510(k) review, 510(k), advamed, Workshops, Education

Hear R&Q and Other Industry Experts Discuss ...

Join R&Q's Marilyn Waxberg and Nancy Morrison as they speak along with other..

RTA, submission, FDA, medical device, 510(k) submission, 510(k) review, Guidance Document, Refuse to Accept, 510(k)

New "Refuse to Accept" Guidance Document for ...

There has been much controversy about the new RTA FDA Guidance document titled..