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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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