FDA finds 17 hospitals failed medical device reporting standards
The FDA had held regulatory meetings with multiple hospitals that have had differences from the Medical Device Reporting Regulation (21 CFR Part 803) and not given responses. The list includes 17 total hospitals that have failed to meet FDA standards in regard to the FDA 843 form.
(The FDA Form 483 notifies the company’s management of objectionable conditions. At the conclusion of an inspection, the the form is presented and discussed with the company’s senior management.)
The table of hospitals complied by the FDA show many problems within the facilities. Hospitals on the list include:
- Cedars-Sinai Medical Center, Los Angeles
- New York Presbyterian Hospital, New York
- Indiana University Hospital, Indianapolis
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Cara joined TriMed Media in 2016 and is currently a Senior Writer for Clinical Innovation & Technology. Originating from Detroit, Michigan, she holds a Bachelors in Health Communications from Grand Valley State University.