The FDA has issued a final guidance for servicing and remanufacturing services for medical devices, which will end the agency’s enforcement discretion for remanufacturing activities. Manufacturers have expressed concerns that they would be required to disclose trade secrets or confidential information in labeling provided with devices and radiological systems, but the FDA said the final guidance’s recommendations for labeling do not encourage or mandate such disclosures.
Jeff Shuren, director of the Center for Devices and Radiological Health (CDRH) at FDA, said in the agency’s press release that the final guidance will aid in removing perceived barriers to obtaining repair or maintenance services. The guidance provides a definition for remanufacturing, which is any activity that significantly changes the finished device’s performance, safety specifications or intended use. In contrast, servicing is defined as any service or maintenance activity that returns the device or system to its original safety and performance specifications and does not change the device’s original intended use.
In a 2018 report, the FDA stated that the evidence then available did not suggest there was a widespread public health concern related to third-party servicing of medical devices that would prompt the agency to add to the regulatory burden of these independent servicing organizations (ISOs). However, original equipment manufacturers (OEMs) were of the view that some ISOs had strayed over the line between servicing and remanufacturing, a practice that OEMs saw as a hazard to patients.
In its comments on the draft guidance, the Advanced Medical Technology Association (AdvaMed) stated that the FDA had previously seemed to suggest that manufacturers should provide instructions that would identify the materials, equipment, supplies and parts numbers that would be needed to reprocess devices. AdvaMed had argued that this type of information is not within the definition of labeling under the Food, Drug and Cosmetic Act, and that such disclosures could expose OEMs to an elevated risk of violation of the regulation. These risks would be incurred by the disclosure of such information to entities that are not in compliance with the QSR when those entities were engaged in remanufacturing activities.
The final guidance recommends that OEMs provide labeling that includes instructions that would facilitate routine maintenance and repair activities for reusable devices. This would include information on key safety and performance specifications and a series of essential technical or functional specifications. Other information that would be included in labeling would include the device’s physical dimensions, electrical characteristics and troubleshooting steps that would aid in determining whether the device or system is still performing within the label’s specifications for safety and performance. The FDA also suggests that product labeling provide any precautionary or warning information related to device servicing, as well as the version and release number of any software.
The FDA will require ISOs to register their facilities with the agency and will inspect those facilities under the same risk-based surveillance framework used for OEM manufacturing sites. ISOs will also be subject to the QSR, which will appreciably increase their cost of conducting remanufacturing services. AdvaMed has estimated that more than 21,000 ISOs are available in the U.S. to provide device servicing, although it is not clear how many of these entities engage in activities that would now be deemed remanufacturing. The agency will convene stakeholders for a review of the guidance, which is planned for June 27.
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