FDA exposes millions of medical device malfunctions kept secret from public

The FDA has formally ended its controversial Alternative Summary Reporting (ASR) program, which provided some manufacturers with exemptions ...

The FDA has formally ended its controversial Alternative Summary Reporting (ASR) program, which provided some manufacturers with exemptions related to reporting individual medical device reports. With that program now scrapped, the FDA has also posted ASR data that was submitted to the agency from 1999 through 2019, enabling the public to download all of that information via 20 individual zip … Continue reading

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FDA exposes millions of medical device malfunctions kept secret from public
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