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# Comments on FDA Medical Device Servicing Report
- URL: https://www.fdaweb.com/comments-on-fda-medical-device-servicing-report/
- Published: 2018-11-21T12:00:00.000Z
- Updated: 2026-09-15T00:46:26.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5142872

The Medical Imaging and Technology Alliance says that it believes that FDA relied on inadequate data collection in reaching some of its conclusions in a report on the quality, safety, and effectiveness of servicing of medical devices. “It is impossible to provide a statistically valid analysis of the extent of problems that have occurred when there has been no prior scrutiny or any regulatory oversight of non-OEM (original equipment manufacturer) service activities which would require reporting of problems,” the comment [letter](https://www.regulations.gov/document?D=FDA-2018-N-1794-0007&ref=fdaweb.com) says. The association also comments on the agency’s proposed actions.

Steris Corp. [says](https://www.regulations.gov/document?D=FDA-2018-N-1794-0008&ref=fdaweb.com) the agency “rightly determined that currently available objective evidence is not sufficient to conclude whether there is a widespread public health concern related to servicing that would justify a change in regulatory requirements. Caution is especially prudent given the reality that the impact of proposed regulatory changes to the providers of these services, including any unintended impact, has not been evaluated.”

The Association of Medical Device Service Organizations [says](https://www.regulations.gov/document?D=FDA-2018-N-1794-0009&ref=fdaweb.com) it agrees with FDA’s conclusion that additional regulatory requirements are not warranted at this time. “Patient safety is already achieved through other standards and requirements for third-party ISOs…,” it says. And the association agrees with FDA that the availability of third-party ISOs to service and repair medical devices is critical to the function of the U.S. healthcare system.

Finally, AdvaMed offers [comments](https://www.regulations.gov/document?D=FDA-2018-N-1794-0010&ref=fdaweb.com) on the report on a section-by-section basis.