The FDA has stirred up more excitement than it may have originally anticipated with its “Refurbishing, Reconditioning, Rebuilding, Remarketing, Remanufacturing, and Servicing of Medical Devices Performed by Third-Party Entities and Original Equipment Manufacturers” docket.

Launched in early March in response to safety concerns that had been brought to the administration's attention, the docket aims to clarify the definitions of terms relevant to third-party refurbishers and servicers of medical equipment.

The FDA's interest in the subject has triggered a range of reactions in the third-party industry spanning optimism that more transparency will make it easier to compete with OEMs, to paranoia that further regulations are on their way and will be bad for business.
According to the agency, it received a number of requests for a 30-day extension by stakeholders.

“Each request conveyed concern that the current 60-day comment period does not allow sufficient time to develop [a] meaningful or thoughtful response to the document,” the FDA wrote. “The agency believes that a 30-day extension allows adequate time for interested persons to submit comments without significantly delaying future workshop on these important issues.”

Industry insiders have stressed that stakeholders should not read between the lines or reply defensively to the docket's questions. Mary Logan, president and CEO of AAMI, has praised the FDA's point-of-contact for the docket, Valerie Flournoy, as a thoughtful and thorough person with a strong track record.

“This is an incredible opportunity for everyone involved in health care technology to educate the FDA because their ears are open,” said Logan in an AAMI statement. “I would encourage companies and health care organizations to submit comments that not only offer their perspective but also evidence to support those perspectives.”

At present, over 40 comments have been submitted. For those who haven't yet shared their perspectives, June 3 is the new deadline.

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