SUMMARY OF KEY LEGISLATION POINTS

  • Requires any person who owns or operates a company engaged in servicing of medical devices to register with the FDA. The FDA will be required to specify the timing, format, and information to be submitted by any person required to register
  • Provides exemptions from registration that would apply to servicing operations conducted by a device user facility or a physician’s office in accordance with applicable laws
  • Defines “servicing” to include refurbishing, reconditioning, rebuilding, remarketing, repairing or other servicing of the device by a person other than the manufacturer of the device
  • Requires the servicer (by amending section 519(a) of the Federal Food, Drug and Cosmetic Act), to establish and maintain reports, if applicable, to assure that a device is not adulterated or misbranded; to report to the FDA whenever the servicer receives or otherwise becomes aware of information pertaining to, among other things, malfunctioning of a device, though the owner or manufacturer may also have this immediate responsibility; and also to submit reports on a quarterly basis depending upon the type of the device and situation — the procedure for the reports will follow FDA requirements
  • Requires the servicer to establish a complaint-handling system equivalent to a system meeting the requirements of 21 C.F.R. 820.198
  • Mandates the FDA to issue final regulations implementing the Servicing Legislation
  • It seems, if adopted, that some independent servicers may well have to employ a compliance officer to address satisfaction of the requirements imposed by the legislation, though they may in fact be duplicative of the scope of responsibilities of the owner, manufacturer or importer.

Independent servicers will likely need to either absorb the cost of compliance (if they can afford to do so) or pass along the cost in terms of higher fees and expenses. In this age of controlling health care costs and encouraging competition, this legislation seems at odds with these goals.

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