CDRH Provides Update on Postmarket Transformation

Almost a year after the FDA announced its action plan for postmarket transformation at CDRH, the agency is making progress on several “immediate priority actions” identified last November. Don St. Pierre, head of CDRH’s Postmarket Transformation Management Group, said he is receiving updates on these initiatives, some of which will affect devicemakers.

In November 2006, CDRH issued a report recommending work on measures to enhance postmarket surveillance at the center. The report predicted these initiatives would take a number of years to implement.

One recommendation was the development of a unique device identification (UDI) system for medical devices, a move that would have “a huge impact on companies,” St. Pierre said.

The agency drafted a concept paper on UDI and held a public meeting on the topic. After collecting comments based on the meeting, the agency has drafted an internal concept paper, which is currently going through internal review. After it completes the review, the FDA will release the concept paper for industry and public comments, he said.