Get Client Alert: FDA Issues Draft Guidance On Mobile Medical Apps

The FDA posts Medical Device Safety Communications to describe the FDA's analysis of a current issue and provide specific regulatory approaches and clinical recommendations for patient management.

FDA follows the procedures required by its "Good Guidance Practice" regulation to issue FDA guidance. FDA guidance describes the agency's current thinking on a regulatory issue. Guidance is not legally binding on the public or FDA.

The regulations document all actions of all drug sponsors that are required under Federal law. CDER Guidance Documents. Guidance documents represent the Agency's current thinking on a particular subject.

Guidances are documents prepared for FDA staff, the regulated industry, and/or the public that describe the Agency's interpretation of, or policy on, a regulatory issue. Unlike statutes and regulations, guidances themselves cannot generally create legally binding requirements.

Guidance documents do not establish legally enforceable rights or responsibilities. They do not legally bind the public or FDA.

The FDA also has a public health responsibility to oversee the safety and effectiveness of medical devices – including mobile medical apps.

Federal Food, Drug, and Cosmetic Act (FD&C Act) The Food and Drug Administration (FDA) enforces the FD&C Act, which among other things regulates the safety and effectiveness of medical devices, including certain mobile medical apps.

Guidance documents describe FDA's interpretation of our policy on a regulatory issue (21 CFR 10.115(b)). These documents usually discuss more specific products or issues that relate to the design, production, labeling, promotion, manufacturing, and testing of regulated products.