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FDA Will Update Its Medical Device Approval Process Following Trenchant Report
The FDA will establish new goals regarding device safety to ensure the agency is “consistently first” in identifying and acting upon safety signals relating to medical devices.
The FDA regulates more than 190,000 different devices produced by over 18,000 companies, and approves approximately 12 new or modified devices daily. The report pointed to the agency’s approval process for medical devices, particularly the expedited processes that are related to the 510(k) process. This can allow new devices to be compared to available products that are quite old. The expedited process can put people at risk, said the Associated Press, which carried out the investigation, noting that the FDA often responds more slowly when it comes to compelling companies to correct what can be dangerous products.
However, the FDA pointed out, it is not always possible to know the full extent of the benefits and risks of a device before it reaches the market.
Some devices, according to the AP , particularly those aimed at treating patients with spinal-cord nerve-related pain, cause more harm than help to patients, including shocks or burns. The AP noted that there have been at least 500 deaths associated with spinal implants, although the report said the data is not specific enough to pinpoint either a faulty device or the surgery itself.
Metal hip replacements and insulin pumps account for more injury reports. Including all types of medical devices, more than 1.7 million injuries and close to 83,000 deaths were reported to the FDA over the last decade.
The FDA said it will include a “vigilant post-market surveillance system” for the “quick identification and evaluation of new or increased safety concerns.” The agency also plans to increase timely public communication about safety issues and effective interventions that will address concerns.
Source: BioSpace.com, November 26, 2018, https://www.biospace.com/article/the-fda-will-overhaul-its-medical-device-approval-process-following-scathing-report-over-safety/?utm_campaign=GenePool&utm_source=hs_email&utm_medium=email&utm_content=67799993&_hsenc=p2ANqtz-9BDOXUZsDOhQIVteNNyX114-RFq-3Jtssg_P4dYVPbaKP4E_aY3m5dajEQuOVM2FrrZxTYg8leMCLgBRlg5NwTMscf_RECc3xDQ6lThIPF7YskfHk&_hsmi=67801244