A discussion draft of the highly anticipated legislation, the 21st Century Cures Act, was released on January 27, 2015 (Draft Act). The Draft Act includes proposals that stem from the 21st Century Cures Initiative that was launched in April 2014 by House Energy and Commerce (E&C) Committee. The Draft Act contains five titles that are spread over almost 400 pages. As stated in the white paper accompanying the Draft Act, discussion regarding the proposed changes is still ongoing, and the E&C Committee requests feedback on the proposals.
The Draft Act proposes changes to federal law which, if enacted, could streamline FDA’s premarket review process, establish a new regulatory framework for health software separate from medical software, enhance the efficiency of FDA review of combination products, encourage use of Bayesian and other statistical methodologies for clinical trials, and add supply chain security for devices.
There are also several placeholders in the Draft Act for future provisions that could be very important to the regulation of medical devices, including section 2161 – “Modernizing Regulation of Diagnostics,” section 2181 – “Interoperability,” and section 2301 – “Precision Medicine.” It will be important to continue to monitor this legislation as new provisions are added and modifications are made to the current language. We will continue to report on this draft legislation as it progresses. To read more about these proposed changes to medical device regulation and other features of the Draft Act, see our alert.