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FDA Ends Controversial ASR Program

The federal agency said to end the program it sent revocation letters to the remaining 13 manufacturers with ASR exemptions.

Well, it seems as if the people spoke and FDA listened.  After receiving significant backlash the agency has ended its Alternative Summary Reporting (ASR) Program.

Under this program, manufacturers of certain devices could request an exemption from the requirement to file individual reports for certain events that were well-known and well-established risks associated with a particular device and to instead submit quarterly summary reports of such events.

“To formally end the program, we’ve issued revocation letters to the remaining 13 manufacturers with ASR exemptions, which covered three kinds of devices: dental implants, implantable cardiac defibrillators and pacemaker electrodes,” Dr. Jeffrey Shuren MD JD director of FDA said in a release.

The agency also posted ASR datasubmitted to the FDA from 1999 to 2019.

The ASR program has come under fire in recent months.

In March, Kaiser Health News reported that at least 1.1 million incidents had been reported through the alternative summary reporting (ASR) repository instead of being disclosed through the public database known as MAUDE. The Kaiser report focuses on the obscurity of the practice, which was created nearly 22 years ago, as MD+DI reported at the time.

Last year, FDA issued a public statement from then Commissioner Scott Gottlieb that said summary reports (including the total number of device events reported) in the voluntary program will be visible to the public in order to improve transparency. Gottlieb would leave the position in April.

 

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