The U.S. Food and Drug Administration (FDA) recently released “A Working Model v.1.0” for its Software Precertification Program, which is aimed at organizations that design, test and monitor software products used for medical purposes (“Software as Medical Device” or “SaMD” products). The goal of the Software Precertification Program is to encourage innovation in digital health technologies by streamlining regulatory approaches while ensuring patient safety and device effectiveness.
With the House and Senate returning to Washington in September, two recently-introduced Senate bills seek to address perceived vulnerabilities in the security of Internet of Things (IoT) devices sold to the federal government and medical devices which regularly connect to the Internet.
Among the key takeaways in the legislation:
- Legislation covers both products sold to the federal government and medical devices;
- Legislation addresses “life of device” obligations of IoT device manufacturers;
- Disclosure and Certification Requirements could create additional liability for manufacturers of Internet of Things devices.