Pathways Picks June 2: Remanufacturing Guide, Budget Picks, Medicare Meetings, and More

article image
ARTICLE SUMMARY:

In this week’s roundup: We are looking out for FDA draft guidance on “remanufacturing” in Next Picks; and then FDA’s 2022 budget request; iRhythm and HeartFlow press for Medicare payment progress; Singapore and Europe weigh in on UDI matters; China transitions to reformed regulations; Canada reports progress; and dates to remember.

Next Picks

What we’re watching for:

You say servicing, FDA says remanufacturing? We are looking out for a draft guidance document in the coming weeks where FDA will attempt to define what it calls “remanufacturing” of medical devices. The guidance will be the next step in an ongoing debate centering on private entities whose business is to help hospitals maintain and repair medical equipment and whether they should be subject to FDA oversight.

A device can either be serviced by the original equipment manufacturer (OEM) or third-party companies (or internally by a hospital). But unlike the manufacturers, the third parties perform work without any requirement to register with FDA, maintain a quality management system, or report adverse events, even though subpar work could contribute to later malfunctions, OEMs complain. In a 2018 report, FDA concluded there wasn’t enough evidence to support additional regulations for third-party servicers across the board. But the agency also noted that it believes many of the situations OEMs complain about, where shoddy servicing leads to adverse events, are not standard device “servicing,” but instead are examples of “remanufacturing,” where the work changes a device’s performance, safety specifications, or intended use. A company that performs remanufacturing is subject to FDA regulations, the agency stressed.

Enter the upcoming draft guidance. In the 2018 report, FDA pledged to clarify how it draws the line between servicing and remanufacturing, and the guidance will be its attempt to follow through on that pledge. Manufacturers will be looking for FDA to define remanufacturing as broadly as possible to force more responsibility on servicing companies. The details of the guidance could also influence efforts in Congress, where bills championed by industry requiring third-party servicers to register with FDA, maintain quality systems, and report adverse events have been floated. On the other hand, several state legislatures are considering “right to repair” bills that would require manufacturers to provide the necessary information and access to facilitate third-party repairs.

×



This article is restricted to subscribers only.

Sign in to continue reading.

Questions?

We're here to help! Please contact us at: