FDA Revised 510(k) Refuse to Accept Policy

FDA has a fully revised guidance “Refuse to Accept Policy for 510(k)s” dated Dec. 31, 2012. This includes a series of checklists including determining if the device is subject to 510(k), referring to all elements of the software submission guidance, and allowing for alternative approaches to information provided along with justification for the alternatives.

 

Cybersecurity Review

Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

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