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Alpha Source acquires BC Technical, doubles size Enables Alpha Source to expand its service offerings and geographical scope

Discussing top-of-mind issues facing biomedical professionals with Codi Nelson Get to know the president of the North Carolina Biomedical Association

Does MITA's service standard sidestep the elephant in the room? ISOs potentially cannot comply if OEMs continue to withhold manuals, passwords

Medical Device Cybersecurity Act of 2017: benefits and burdens Does proposed legislation overlook the needs of third-party servicers?

What do unconventional service models tell us about the bone densitometry market? Checking in with the partnership between Alpha Source and GE

Philips and GWU study reveals need for improvement in EDs worldwide Influenced by poor decisions on where to seek medical care

Bayer to sell Multi-Vendor Service business Will increase focus on contrast agents and image acquisition devices

The parts and services big three: What every health care system should be asking Questions that will help mitigate issues down the road

Third-party medical equipment service: high stakes in the ongoing debate Checking in with the FDA's examination of third-party stakeholders

Nationwide hosts IAMERS forum on QMS in advance of FDA report Stakeholders discuss ISO quality management systems

Amendment requiring FDA to report on ISOs within 180 days goes to House vote

An editorial by Robert Kerwin
General Counsel, IAMERS

Today the House Energy and Commerce Committee considered the reauthorization of the FDA, H.R. 2430 (FDA Reauthorization Act of 2017) and amendments to the reauthorization.

This reauthorization which last occurred in 2012 will now be submitted to the full House for a vote. Among the amendments which were offered was an amendment offered by Congressman Costello and Congressman Peters which requires issuance by the FDA of a report on servicing.

This amendment was approved by the committee. Among the requirements of the amendment are the following:

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1. Not later than 180 days after enactment, the FDA will submit to the House and Senate committees a report on how the FDA intends to ensure the quality, safety and continued effectiveness of devices with respect to servicing "performed by any entity engaging in such servicing".

2. Servicing is defined in the amendment as "servicing" with respect to a device, refurbishing, reconditioning, rebuilding, remarketing, remanufacturing, repairing, or other servicing of the device by a person other than the "manufacturer of the device".

3. The FDA will be required to include in the report the status of, and findings to date with respect to, the notice entitled "Refurbishing, Reconditioning, Rebuilding, Remarketing, Remanufacturing, and Servicing of Medical Devices Performed by Third Party Entities and Original Equipment Manufacturers"; request for comments published by the FDA on April 25, 2016 [note: believe the April reference is a typo since the first notice was in March 2016].

4. The report should include how the FDA intends to define the specific activities performed on a device by the manufacturer of the device or other entities;

5. The report is also to include a description of the statutory or regulatory authority of the FDA, used to oversee and regulate servicing conducted with respect to the device.

6. Also required to be included in the report are details on how the FDA intends to protect the public health by ensuring consistent quality, safety and continued effectiveness of devices with respect to which servicing has been performed by any entity engaged in such servicing.

7. The amendment also requires that information be provided on how the FDA can better understand the device servicing industry, including the size, scope, location and composition of entities performing such servicing and the rate of adverse events related to such servicing.
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