FDA Rejects Push for New Regulatory Action on Medical Device Service
Posted May 15, 2018
The Food and Drug Administration (FDA) has concluded that there is insufficient evidence to justify imposing additional regulations on third-party servicers of medical devices. The announcement came this morning with the publication of a highly anticipated report on the quality, safety, and effectiveness of medical device servicing that was required as part of the FDA Reauthorization Act of 2017.
The full article from AAMI on the new FDA report is available here.