The Institute of Medicine’s 280-page report on the FDA’s 510(k) clearance process for medical devices was released yesterday. Commissioned by the FDA Center for Devices and Radiological Health (CDRH), the report aimed to answer two fundamental questions: “1. Does the current 510(k) clearance process protect patients optimally and promote innovation in support of public health? 2. If not, what legislative, regulatory, or administrative changes are recommended to achieve the goals of the 510(k) clearance process optimally?”
Divided into seven informative sections, the report is worthy of at least a skim because it begins with an interesting summary of key medical device legislation (i.e. regulation began in 1938; Congress passed the Medical Device Amendments of 1976 which established the 510(k) process) and ends with major conclusions and recommendations. A key issue for the committee is that the 510(k) process clears any moderate-risk device that is substantially equivalent to any other device cleared by the same process, referred to as a predicate device, without a “legal basis to be a reliable premarket screen of the safety and effectiveness”. They were, however, unable to determine whether this premarket streamlining process had a positive or negative effect on innovation, and instead recommended the FDA commission another report on that matter.
If you do not have time to wade through the 280-page report, the overall summary is below:
The committee finds that the current 510(k) process is flawed based on its legislative foundation. Rather than continuing to modify the 35-year-old 510(k) process, the committee concludes that the FDA’s finite resources would be better invested in developing an integrated premarket and postmarket regulatory framework that provides a reasonable assurance of safety and effectiveness throughout the device life cycle. This new framework should:
- be based on sound science;
- be clear, predictable, straightforward, and fair;
- be self-sustaining and self-improving;
- facilitate innovation that improves public health by making medical devices available in a timely manner and ensuring their safety and effectiveness throughout their lifecycle;
- use relevant and appropriate regulatory authorities and standards throughout the life cycle of devices to ensure safety and effectiveness; and
- be risk-based.
The ball is now in the FDA’s court. As a season-ticket holder, Medgadget will keep you updated on what the FDA does with it.
Read the full report: Medical Devices and the Public’s Health – The FDA’s 510(k) Clearance Process at 35 Years
Visit the IOM’s report page featuring content related to their 510(k) clearance process report…
Watch the public briefing that took place at 11 am on Friday, July 29, 2011…
Learn about the controversy surrounding the report….