New legislation would mandate all ISOs register with FDA

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New legislation would mandate all ISOs register with FDA

April 27, 2017
Business Affairs HTM Parts And Service
An editorial by Robert J. Kerwin
IAMERS General Counsel

On Tuesday, April 25, 2017, Congressman Ryan Costello (R-PA) and Congressman Scott Peters (D-CA) with the support of the Medical Imaging Technology Alliance, filed H.R. 2118 seeking to require registration of independent servicers of medical devices.

The Act — self-described as the “Medical Device Servicing Safety and Accountability Act” — would require the FDA, not later than 18 months after passage, to issue final regulations which:

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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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Richard Geertson

H.R. 2118

May 04, 2017 10:47

Mr. Kerwin made several cogent (devastating to the OEM narrative) points during his testimony before the House Energy and Commerce Subcommittee... but perhaps the MOST persuasive was his invitation to produce ANY tangible evidence that H.R. 2118 is anything more than a solution to a problem that does not exist.
Bravo Robert!

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Robert Burbury

re: H.R. 2118

May 05, 2017 10:30

Agree!
If there is a problem with poor workmanship with servicing medical equipment in USA... why not require a Medical Service License in order to repair and calibrate medical devices.
With different levels of license grades like we did with the FCC many years ago??
Pass a test get a license. Charge for the test$$
Got to have a license to cut hair.

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