mdi ConsultantsFDA Update – June 30, 2020
This is an informational notice
The FDA requests your input for the 21st Century Cures Act Report
On December 13, 2016, the Cures Act was signed into law. This was designed to help accelerate medical product development and bring innovation and advances to patients who need it faster and more efficiently. The FDA issues a guidance document Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act with the most current interpretations of the medical software provisions in the Cures Act. The FDA is currently requesting your input on patient safety. This includes best practices to promote patient safety, education, and competency, associated with the medical software functions that are excluded from the device definition by the Cures Act for inclusion in a report to the public.
The FDA is seeking input from all interested parties: patients, consumers, healthcare providers, startup companies, health plans or other third-party payers, venture capital investors, information technology vendors, health information technology vendors, small business purchasers, employers, and other stakeholders. Comments can be submitted to the public docket at www.regulations.gov using docket number FDA-2018-N-1910.
View the full request for input here.
If you have any questions related to this request for input, or the included guidance document, email mdi Consultants at [email protected] RE: Cures Act.