FDA schedules new medical device workshop for October
The FDA has announced a public workshop called, “Refurbishing, Reconditioning, Rebuilding, Remarketing, Remanufacturing, and Servicing of Medical Devices Performed by Third-Party Entities and Original Equipment Manufacturers,” which is scheduled for October 27 and 28.
This workshop comes after the FDA opened a docket and asked for public comments from “Original Equipment Manufacturers, health care establishments and third-party entities” about the refurbishing, reconditioning, rebuilding, remarketing, remanufacturing and servicing of medical devices earlier this year.
“The purpose of the workshop is to convene interested parties to discuss regulatory aspects of third party processes ... and address 'Working Questions' that the FDA designed from the comments made to the docket, to promote understanding of challenges and best practices to mitigate risks associated with these activities,” the FDA said in its announcement.
The workshop will be held at the FDA White Oak Campus in Silver Spring, Maryland, but it will also be available online with no registration necessary. It is free to attend the workshop in person, but interested parties must register by September 23.
More information, including how to register, is available on the FDA’s website.
Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.