Category Archives: Medical Devices

New CDRH Guidance in October

by Barbara Unger, GMP Quality Expert, and GMP Regulatory Intelligence Editor-in-Chief

The FDA has been on a bit of a tear in publishing guidance for devices and generic drugs.  Here we address the CDRH guidance issued between September 29th and October 25th 2017 and provide summaries of their content.  Seven guidance listed below are final, and one is published for comment.  Many are associated with requirements in the Medical Device User Fee legislation, MDUFA.  Expect more of these moving forward into the MDUFA IV era.

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The FDA Re-Org Has Begun. What Does it Mean for You?

by Barbara Unger, GMP Quality Expert, and GMP Regulatory Intelligence Editor-in-Chief

BACKGROUND:

The FDA began a plan to align the Office of Regulatory Affairs (ORA) into a ‘program based structure’ in 2013.  This reorganization is now being implemented. The ORA is the lead for all FDA field activities including inspections of regulated products and their manufacturers, and review of imported products.  Effective May 15, 2017, we enter the transition phase as the FDA moves to reorganize the ORA structure and function to align with the agency’s centers. The FDA provides information on each of the areas, including a ‘fact sheet’ and a ‘boundary map’ for these offices.

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We Learned 5 Things from 2014 FDA and EU GMP Drug Enforcement Actions

2014 proved to be another busy year for the FDA.  We asked Barbara Unger, President of Unger Consulting and Editor-in-Chief of GMP Regulatory Intelligence, to summarize her key take-aways from the enforcement actions of the FDA and EU in 2014. Here’s Barbara: Continue reading