How Will FDA’s CDRH Reorganization Impact Me?

Industry News
Written By Monica Burt

The question asked to me was: How will FDA’s reorganization of the Center for Devices and Radiological Health (CDRH) impact my organization?

Each of the original seven offices of FDA’s CDRH underwent changes to generate efficiencies that will allow FDA to better support and advance CDRH’s public health mission and vision. The changes integrated CDRH’s premarket and postmarket program functions along product lines, allowing FDA to optimize oversight and decision making by leveraging the knowledge of their functional specialists across the product lifecycle.

Monica Burt

Monica Burt, EMBA, is a Quality and Operations professional with over 17 years of experience in the medical device and human tissue industries having most recently served as the Global Director of Quality and Director of Strategic Sourcing at Wright Medical. Mrs. Burt has also held Quality leadership roles at Medtronic Spine and Biologics and Smith and Nephew Orthopedics. Mrs. Burt currently serves as the Senior Partner in the MB&A Consulting firm specializing in FDA, ISO and MDSAP audit management and response, contract Due Diligence Inspections and US/Asia supplier relationship management. Her GXP experience includes GCP, GLP, GMP and GDP. She is also certified as a Lead Auditor and holds a Lean Six Sigma Blackbelt Certification.

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