FDA Guidance for Industry: Multiple Function Device Products: Policy and Considerations
Title:
FDA Guidance for Industry: Multiple Function Device Products: Policy and Considerations
Origin/Publisher:
FDA
Content:
Medical products may contain several functions, some of which are subject to FDA’s regulatory oversight as medical devices, while others are not. Section 3060(a) of the 21st Century Cures
Act (Cures Act) amended the Federal Food Drug, and Cosmetic Act (FD&C Act) to add section 520(o), which excludes certain software functions from the definition of device in section 201(h)of the FD&C Act