Under new rules, they'll have up to 3 months to report product malfunctions
Under an agreement with the Food and Drug Administration that’s headed for a Congressional vote, manufacturers of medical devices—a $148 billion product category covering everything from insulin pumps to breast implants and cardiac defibrillators—could be allowed to report malfunctions of their products less frequently than they currently do.
While injuries or deaths related to their products still have to be promptly reported, new rules would allow medical device makers to report product malfunctions every three months instead of within 30 days of an issue occurring, the New York Times reports. Such malfunctions would include cases where products don’t work as intended, and potentially could injure the user.
The change is part of a pact between the FDA and the medical device industry, renegotiated every five years, that includes the amount of fees manufacturers have to pay the regulator for reviewing their products. The new version is scheduled for a vote in the House Wednesday, according to the Times.
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Critics like consumer advocates oppose the move. They say medical device problems are already underreported as it is, adding that recent cases have shown that flaws or faults first reported as less serious would only later be linked to more serious cases of malfunctions. However, the NYT also hints at the bureaucratic challenge of processing such reports: the FDA currently receives about 65,000 reports of “adverse events” a month.
Meanwhile, executives of the device trade tells the NYT that the rule change won’t affect their duty to tell the FDA about cases where consumers are harmed by devices. They also cast doubt on claims that under-reporting is widespread.
The NYT notes that neither the FDA nor the Government Accountability Office (GAO) could identify the percentage of medical device issues that have gone unreported.