US FDA: No Additional Regulations for Medical Device OEMs and Third-party Service Providers

EMERGO SUMMARY OF KEY POINTS:

• US FDA issues a required report on the continued quality, safety, and effectiveness of medical device servicing.
• Evidence is insufficient to determine whether additional regulations are necessary for OEMs and third-party service companies.
• The FDA proposes additional actions based on the report’s findings.

The US Food and Drug Administration has cited insufficient evidence regarding public health concerns to warrant new regulatory requirements for original equipment manufacturers (OEM) and third-party servicers of medical devices, but will take less formal steps to ensure safety and effectiveness of these entities’ products and services.

In a recent report, FDA addresses the quality, safety, and effectiveness of servicing medical devices.

As the report was a required provision of the 2017 Food and Drug Administration Reauthorization Act (FDARA), the contents of the report stem from a 2016 open docket and public workshop. The aim is to shed light on the quality, safety, and effectiveness of device servicing by original equipment manufacturers (OEMs) and third party servicers to determine if additional regulations are required.

Key conclusions from the public docket and workshop report

With differing views on the quality of device service provided by OEMs, independent service organizations, healthcare establishments, biomedical and clinical engineers, healthcare technology management professionals, and professional trade associations, the report reveals objective information. Some conclusions include:

• The evidence does not conclude there is a widespread health concern that would warrant imposing additional regulatory requirements.
• Many OEM and third-party entities provide high quality, safe, and effective device servicing.
• A majority of the negative comments and complaints regarding adverse clinical events or fatalities associated with servicing were related to remanufacturing rather than servicing of devices.
• The presence of OEMs and third-party device servicing is crucial to the US healthcare system.

Proposed FDA actions for device servicing

While imposing additional/different regulatory requirements is deemed unnecessary due to insufficient evidence, the FDA does intend on acting regarding medical device servicing. A few examples are:

• Adopt quality management principles
• Define servicing versus remanufacturing
• Increase cybersecurity measures associated with medical device servicing
• Assess device servicing quality, safety and effectiveness through evidence development

FDA member communities and public-private forums

The FDA’s Center for Devices and Radiological Health (CDHR) has established a forum, or Collaborative Community, where information is exchanged between the public and private sectors to solve shared problems. With the success of the FDARA report’s public exchange and the success for the CDHR Collaborative Community, the FDA is now considering establishing such a Collaborative Community targeting quality, safety and effectiveness of OEMs and device servicing.

EMERGO will provide any updates to the FDARA report on medical device servicing as well as and information regarding the creation of any collaborative communities as they are announced.

Related US FDA medical device regulatory resources from Emergo:

• US FDA 510(k) consulting for medical device and IVD companies
• FDA QSR (21 CFR Part 820) consulting for medical device companies
• Medical device design, process and software validation support