FDA Releases Guidance Priorities - McDermott+Consulting

FDA Releases Guidance Priorities

The Food and Drug Administration (FDA) has released guidance documents outlining its regulatory agenda for the Fiscal Year 2015.

For the first time, the FDA has released final and draft guidance “A” and “B” documents, prioritizing certain projects such as final guidance documents for regulatory oversight of laboratory developed tests, reprocessing medical devices in health care setting, and applying human factors and usability engineering to optimize medical device design.

The FDA has established docket FDA-2012-N-1021 for comments on any of the proposed guidance documents.


The full lists can be viewed on the FDA website here.