Proposed legislation could have a huge impact on the HTM community, especially each and every independent service organization (ISO) that services and/or repairs medical devices.
U.S. Rep. Ryan A. Costello (R-PA) introduced “H.R.2118 – Medical Device Servicing Safety and Accountability Act” earlier this month. It was referred to the House Committee on Energy and Commerce.
In summary, if the proposed legislation is passed and becomes law it would require the registration with the FDA any person who owns or operates any establishment in any state engaged in the servicing of a device or devices, or is otherwise engaged in the servicing of a device or devices.
It would also require that such a person or company to establish a complaint handling system equivalent to a system meeting the requirements of section 820.198 of title 21, Code of Federal Regulations (or successor regulations); and provide for an exemption from such registration that applies to servicing operations conducted by a device user facility (as defined in section 519(b)(6)), or a physician office operating in accordance with any applicable state or local laws; and does not apply to device servicing operations conducted by persons who contract with device user facilities or physician offices to service devices.
To view the proposed legislation, click here.
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