Enter to open, tab to navigate, enter to select
Obama Signs 21st Century Cures Act into Law
Practical Law Legal Update w-005-0416 (Approx. 4 pages)
Obama Signs 21st Century Cures Act into Law
by Practical Law Commercial Transactions
| Published on 16 Dec 2016 • USA (National/Federal) |
President Obama recently signed the 21st Century Cures Act into law. Among other things, this new law removes certain health-related and mobile medical apps from the definition of medical device under the Federal Food, Drug, and Cosmetic Act.
On December 13, 2016, President Obama signed the 21st Century Cures Act (21st Century Cures Act, H.R. 34 (2016)) into law. Among other things, the 21st Century Cures Act amends Section 520 of the Federal Food, Drug, and Cosmetic Act (FDCA) (21 U.S.C. § 360j) by:
- Removing many mobile health-related and medical apps from the FDCA's definition of medical device, including any software function that is intended:
- for a health care facility's administrative support;
- for maintaining or encouraging a healthy lifestyle (as long as the software is unrelated to the diagnosis, cure, mitigation, prevention, or treatment of a disease or condition);
- to serve as electronic patient records; or
- for transferring, storing, converting formats, or displaying clinical laboratory test or other device data and results, findings by a health care professional with respect to such data and results, general information about such findings, and general background information about such laboratory test or other device.
- Requiring the Food and Drug Administration (FDA) to issue a final order through notice and comment rule-making to identify software functions that should still be considered medical devices because they would be reasonably likely to have serious adverse health consequences.
For more information on how the FDA regulates medical devices, see Practice Note, FDA Medical Devices Regulations and FDA Medical Devices Regulations Checklist.