FDA Provides Highlights of the Updated Compliance Program for Inspection of Medical Device Manufacturers

Plenary Session

Have you heard? The Compliance Program for Inspection of Medical Device Manufacturers has been updated! This new CP addresses FDA’s current thinking on inspections and compliance. It also includes added sections on Inspectional Preparation, assessing post-market information and quality data during an inspection, Unique Device Identifier UDI, and coverage of radiation emitting devices. In addition, the Regulatory Section (Part V) includes updates on Regulatory Significance (previously Compliance Decision) with a more accurate depiction of Situations 1 and 2; a new section called “Factors to Consider” to determine the appropriate regulatory action; an added section, “Other Communications and Compliance Activities,” which includes Pre-Market Approval (PMA) decisions, MDSAP program, and other communications used by the Agency to promote voluntary compliance; and added references to newer policies such as Benefit-risk, emergency provisions, exceptions, or participation in Agency initiatives. If you anticipate FDA interaction, you will want to understand this update!

Moderator

Susan Matthias, Consumer Safety Officer Special Assistant, Office of Medical Device and Radiological Health Operations (OMDRHO), Office of Regulatory Affairs (ORA), FDA

Speakers

Gina Brackett, Director, Compliance Branch Division 1/East, Office of Medical Device and Radiological Health Operations (OMDRHO), Office of Regulatory Affairs (ORA), FDA

Jake Dyer, Office of Product Evaluation and Quality, Center for Devices and Radiological Health (CDRH), FDA

Lauren Priest, Medical Device Compliance Officer, Office of Medical Device and Radiological Health Operations (OMDRHO), Office of Regulatory Affairs (ORA), FDA

Brian Putz, Commander, Public Health Service Supervisory Investigator, Office of Medical Device and Radiological Health Operations (OMDRHO), Office of Regulatory Affairs (ORA), FDA