FDA identifies hospitals non-compliant with medical device reporting standards

At least fifteen hospitals across the United States failed to comply with the medical device reporting requirements, according to the FDA.

The FDA issued a Form FDA 483 to some prominent hospitals, including Massachusetts General Hospital and New York Presbyterian Hospital, for not promptly reporting deaths and injuries related to medical devices pursuant to 21 CFR Part 803. Under the federal regulation, user facilities, such as hospitals and health centers, have only ten days to submit reports about deaths of patients and serious injuries linked to medical devices to its manufacturer and the FDA. The rule also states that a user facility should maintain a medical device event filing system, which can be inspected by FDA. Out of 17 hospitals, 15 medical centers reportedly demonstrated failures to comply with the federal rule following FDA nationwide inspections. The inspection was initiated last December 2015.

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