By Stewart Eisenhart, Emergo Group

The US Food and Drug Administration has published final guidance on its process for accepting and responding to 513(g) Requests for Information from medical device manufacturers and sponsors.

According to the guidance, 513(g) requests pertain to the classification of a particular device or the regulatory requirements that particular device must meet in order to comply with the FDA; 513(g) requests are suitable in instances where manufacturers cannot easily determine which device class is most appropriate for their devices, and would like to confirm their classification decisions with the regulator.

The guidance recommends that interested manufacturers submit two copies of their 513(g) requests to the Center for Devices and Radiological Health (CDRH) or the Center for Biologics Evaluation and Research (CBER), as well as associated fees for reviewing 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

Finally, 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. 

Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.