The Institutes of Medicine’s long-awaited review of the FDA’s medical device 510(k) process hit seven main points:
- First and foremost, scrap the existing 510(k) program as quickly as possible. Replace the "substantial equivalence" standard that gives medical devices a pass for demonstrating that they are similar to already-cleared devices with a framework that focuses more heavily on premarket and postmarket surveillance.
- Boost postmarket surveillance and be more liberal with wielding authority over violations. Use ongoing performance data to form controls on devices, manage the risk-benefit ratio through a medical device’s life cycle and inform the design of the new regulatory framework.
- Strengthen the FDA’s postmarket authority with Congressional legislation to give the agency the ability to better handle legal violations and products that pose unacceptable risk to consumers.
- Revamp the de novo process, the mechanism through which the FDA down-classifies devices to a lower-risk category with less stringent review. Run a pilot version of a revamped de novo process to determine the feasibility of scrapping the 510(k) review system, and consider expanded use of outside experts, pre-review device-exemption meetings and conditional clearances.
- Implement continuous quality-improvement within the agency to provide for upgraded technology and management infrastructure. The report calls the FDA’s existing systems "inadequate," and says that the agency can’t trace historical 510(k) decisions when determining whether a new device falls within "substantial equivalence" of an existing device.
- Commission in internal review of the 510(k) process and its effect on industry, and consider ways to measure innovation beyond "time to market" or the number of devices within a particular category.
- Strengthen review of medical software within a device, software as a device and software used to produce a device, trends that are expected to continue.
The report finds that "current guidance on software validation is insufficient for preventing serious software-based device failures."
- Remove 510(k) eligibility for all high-risk (Class III) medical devices, a task that has been put off for 35 years with the effect of allowing high-risk devices to continue to enter the market through the 510(k) process.
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