Copies of all proposed labeling for the device must be included in the PMA submission. The labeling must comply with the requirements in 21 CFR 801 (Labeling) or 21 CFR 809 (In Vitro Diagnostic Products for Human Use). That is, the label must include the common name of the device, quantity of contents, and the name and address of the manufacturer. In addition, labeling may include prescription use restrictions, information for use (including indications, effects, routes, methods, and frequency and duration of administration; and any relevant hazards, contraindications, side effects, and precautions), instructions for installation and operation, and any information, literature, or advertising that constitutes labeling under Part 201(m) of the FD&C Act.
The indications for use is based on the nonclinical and clinical studies described in the PMA. Indications for use for a device include a general description of the disease or condition the device will diagnose, treat, prevent, cure, or mitigate, including a description of the patient population for which the device is intended. Any differences related to gender, race/ethnicity, etc. should be included in the labeling.
During the review process, FDA will approve an application on the basis of draft final labeling if the only deficiencies in the application concern editorial or similar minor deficiencies in the draft final labeling. Approval will be based on the condition that the applicant incorporates the specified labeling changes exactly as directed and submits to FDA a copy of the final printed labeling before marketing.
Additional guidance on labeling can be found in the following guidance documents. The guidance documents are organized in the following categories: PMA Labeling Guidance; General Labeling Guidance; and In Vitro Diagnostic Device Labeling Guidance.
General Labeling Guidance
- Device Advice - Labeling Requirements
- Device Labeling Guidance #G91-1 (blue book memo)
- Draft Report on Medical Device Labeling: Patients' and Lay Caregivers' Medical Device Information and Labeling Needs7 - Results of Qualitative Research (PDF - 86KB)
- Summary of the Medical Devices Technical Corrections Act (MDTCA) (PDF Version) (PDF - 268KB)
- Guidance on Medical Device Patient Labeling - Final Guidance for Industry and FDA Staff (PDF - 333KB)
- Labeling - Regulatory Requirements for Medical Devices (FDA 89-4203) (PDF - 3MB)