The US Food and Drug Administration (FDA) recently ended its Alternative Summary Reporting (ASR) program for medical devices, revoked the related exemptions and on Friday made available on its website all adverse event reports received under ASR exemptions from 1999 to 2019.
FDA said it initially indended the ASR program to be for “specific well-known and well-characterized events associated with specific devices,” and that exempted submissions excluded events where the device may have caused or contributed to a patient death, except for limited circumstances.
Jeff Shuren, director of FDA’s Center for Devices and Radiological Health (CDRH), said in a statement that since the ASR program’s inception in 1997, FDA granted 108 exemptions to individual manufacturers.
« 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. Today, the agency also posted ASR data submitted to the FDA from 1999 to 2019, » Shuren added.
And similar to the adverse event reports contained in FDA’s main Manufacturer and User Facility Device Experience (MAUDE) database, data in ASR reports cannot be used to determine “rates of adverse events due to under-reporting of events, inaccuracies in reports, lack of verification that the device caused the reported event, and lack of information about frequency of device use,” FDA said…