Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, was featured in Bloomberg BNA Medical Devices Law & Industry Report, in “FDA May Change Refurbished Device Oversight, Attorney Says,” by Michael Williamson.
Following is an excerpt:
Various entities have expressed concerns about the quality, safety and continued effectiveness of medical devices that have been refurbished, reconditioned, rebuilt, resold, remanufactured, serviced or repaired by original equipment manufacturers and third parties, including health-care establishments such as hospitals, the notice said. The FDA notice asked for comments “from the widest range of interested persons,” including those who are engaged in one or more of the refurbishing activities “or who utilize refurbished, reconditioned, rebuilt, remarketed, remanufactured, or third-party serviced and repaired medical devices.”
Regulators wouldn’t normally take a step like this if they hadn’t heard some pretty concrete concerns, Thompson said. “So my guess is there will be changes,” he said, adding that “my suspicion is that they will tighten the requirements for the validation that refurbishers must do before they resell products.”