The New York Times just recently broke news of the coming controversy surrounding an Institute of Medicine report on the medical device industry that will be released this Friday.
Commissioned by the Food & Drug Administration in response to the apparent increase in medical device recalls due to failures and patient injuries over recent years, the report is expected to propose more stringent industry-wide regulations such as tougher approval processes for devices such as defibrillators, hip implants, and hospital pumps. The specific focus of the report is on the 510(k) Medical Device Clearance Process.
Though such reports have not been unusual in and of themselves, controversy has emerged because as the NYT describes it:
Allies of the medical device industry are waging an extraordinary campaign in Washington to discredit a coming report by one of the country’s pre-eminent scientific groups that examines possible new regulations on the industry… [They] have taken the highly unusual step of making a pre-emptive strike, arguing that the report is biased. That attack began even before the study panel finished its review, and has intensified in recent weeks. Device producers have also released a series of their own reports that say more regulation would slow innovation, harm patients and cost jobs. An official of a group that represents surgeons who implant hips and other artificial joints has also voiced support for a recent filing by a pro-business organization that challenged the scientific report’s credibility and argued that the F.D.A. was statutorily required to ignore it.
Hopefully any action taken from this report will be positive: increasing patient safety while at the same time not unduly delaying the approval of safe, emerging medical devices that benefit patients immediately. If the process becomes quagmired unnecessarily you can expect less frequent Medgadget posts announcing newly approved devices!
Original article at NYT: Study of Medical Device Rules is Attacked, Unseen
Institute of Medicine’s press release announcing the soon-to-be-released report…
Register for the live video webcast of the briefing on Friday, July 29th at 11 AM EDT…
More about the 510(k) clearance process on the FDA website…
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