FDA ends program that allows device companies to not report risks, adverse events

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The FDA has formally ended its Alternative Summary Reporting program, which allowed device manufactures to request exemptions from the requirement to file reports on certain events and risks from devices, according to a news release issued June 21.

Instead, manufacturers will be required to submit quarterly summary reports of the adverse events.

Since 1997 when the program was founded, the FDA granted 108 exemptions to individual manufacturers for certain well-known events associated with specific devices.

Revocation letters have been sent to the remaining 13 manufacturers with ASR exemptions. These companies made dental implants, implantable cardiac defibrillators and pacemaker electrodes.

The FDA has created a public database that is filled with "companion" medical device reports. The MAUDE database included the total number of events that were summarized for the quarter.

To read more about the program, click here.

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