FDA update April 10, 2012

Guidance for Industry and Food and Drug Administration Staff FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act

The purpose of this guidance is to establish procedures for submitting, reviewing and responding to requests for information regarding the class in which a device has been classified or the requirements applicable to a device under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) that are submitted in accordance with section 513(g) of the FD&C Act, 21 U.S.C. 360c(g).

The guidance recommends that interested manufacturers submit two copies of their 513(g) requests.

The following components make up an acceptable 513(g) submission:

  • Cover Letter: date of 513(g) request, device name, specific questions, submitter’s name and contact information
  • Device Description: list  of materials used in the device, photographs and engineering drawings or samples, summary of device’s operational principles, description of device’s energy requirements and description of similar devices already commercially available in the US
  • Labeling: any proposed labeling and promotional material for device, or any labeling information for similar devices already marketed in the US

Once the FDA receives a 513(g) request, a response can take up to 60 days. Typical responses to a 513(g) request may include the following:

  • Whether the product in question is a medical device in accordance with section 201(h) of the Food, Drug & Cosmetics Act, as well as whether the device appears to be Class I, II or III
  • Whether the product in question does not qualify as a medical device, and if it does or does not fall under FDA jurisdiction
  • Whether the product in question qualifies as a combination product for which the CDRH or CBER may or may not have primary oversight; consultation with the Office of Combination Products may be necessary


FDA reviewers may contact companies for additional information related to their 513(g) requests in the event of incomplete submissions. In such cases, firms have 30 days to respond to these requests from the FDA in order to keep their 513(g) process open.

mdi has been using and recommending this process for an official classification on a device when it falls into a grey area for many yeard. But, if there is a good chance that the device would require a 510(k), it is better to move forward with a 510(k) submission. If the device is found to be exempt from the 510(k) the FDA will come back with that classification as well. This has to be on decided on a case by case regulatory strategy. If you would like to discuss your device and regulatory situation please contact us.

Any questions on this FDA update please email us at info@mdiconsultants.com and Ref: Final 513(g) Guidance. For more information on this FDA Update you can go to the following link: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM209851.pdf