INDUSTRY ID’S TOP GUIDANCE WISH LIST FROM FDA (Orthopedics This Week)
Each year, the Food and Drug Administration (FDA) publishes two lists of Draft Guidances the agency hopes to finalize during the next year. The agency divides these into "A" and "B" lists, based on which guidances are most important.
In February 21, 2017, medical device companies, through the largest industry group, AdvaMed, identified 7 of the 12 FDA 2017 draft guidance documents from the "A" list most important to the companies.
Those seven “A” list guidance documents are:
Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices. AdvaMed says this is an important developing area that guidance with the appropriate scope would help foster. "That being said, the narrow scope of the draft guidance greatly reduced its usefulness. We urge FDA to revise the draft guidance in a manner that reflects our comments."
Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices.
New or revised procedural guidances for MDUFA IV implementation.
Suggested Format for Developing and Responding to Deficiencies of Standards in FDA Regulatory Oversight of Next Genera...
