Would you let anyone else service your device?
The FDA is inviting medical device OEMs and other stakeholders to comment on its proposal to address the servicing of medical devices by third parties
The agency is proposing to address refurbishment, marketing, manufacturing and servicing of medical devices by groups other than the OEM. And since March 2016 it has been inviting stakeholders to share their comments on their proposals.
But, as highlighted by The National Law Review, at time of writing less than 40 parties have left comments, and hardly any have come from manufacturers.
Specifically, the agency is looking for examples of problems that may occur when devices are services, refurbished or re-marketed.
Manufacturers have only got until May 3rd to have their say, and Benjamin Zegarelli, writing for the National Law Review, urged OEMs to participate:
“All medical device manufacturers whose products could be serviced by ISOs once on the market should be weighing in on this issue to ensure FDA understands the risks associated with third-party servicing and the potential burdens new regulations could place on manufacturers.”
Zegarelli added: “Since manufacturers are required to maintain their medical devices according to their proprietary design specifications, manufacturers have a unique perspective on these questions that FDA should hear. For instance, manufacturers have incomparable knowledge of their devices’ failure modes and the information needed to service their devices. Also, since manufacturers must handle customer complaints, they have direct knowledge of the potential risks introduced by using ISOs or by user facilities employing biotechnicians to service medical devices.”