Section 513(g) of the Federal Food, Drug, and Cosmetic Act is providing a means for device manufacturers to obtain information about the Food and Drug Administration’s views regarding the classification of a device. The 513(g) exempt devices process is allowing a sponsor to ask questions such as whether FDA regulates a given device, if the device is exempt, or the least burdensome regulatory pathway for a device, which introduces a new technology or new intended use. PDG will be used this and other research to provide a regulatory foundation similar to a 510(k). These are including predicates and validated test results from the device manufacturer such as stability, bio compatibility, etc.
Guidance Of 513(G) Exempt Devices
This is interested in manufacturers that are submitted 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). These are associated with fees for reviewing requests. PDG may be recommended pre-sub discussion feedback requests and/or discussions with CDRH preceding submission of the 510(k). Measures are important to adequate preparation of the submission. PDG will be your regulatory voice at FDA that is including assistance with responses to any deficiencies. There are the following components make up an acceptable 513(g) submission:
- Cover Letter: these are including date of 513(g) request, device name, specific questions, submitter’s name, and contact information
- Device Description:it has a list of materials used in the device, photographs, and engineering drawings or samples and a summary of the device’s operational principles. This description of the device’s energy is the requirement and description of similar devices already commercially available.
- Labeling:it has any proposed labeling and promotional material for the device, or any labeling information for similar devices already marketed.
Responses Of 513(G) Request
FDA has received a 513(g) request, a response can be taking up to 60 days. There are these types of responses to a 513(g) request the following:
- Whether the product in question is a medical device following 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 to keep their 513(g) process open.
How To Submit A 513(G) Application
- Medical device companies should be submitted a 513(g) application in writing to the appropriate office and identify it as such. These applications are containing a cover letter, a description of the device, a description of the indicated use of the device, any proposed labeling and marketing materials for the device.
- The cover letter should be identifying the request as a 513(g) request for information. These are also included in the date of the request, the name of the device, specific questions regarding the class of the device, the requester’s name and contact information, and the 513(g) requester’s signature.
- The Food and Drug Administration is required to collect user’s fees for requests for information. They are not accepting a request for information until all of the fees that have been paid and including facility registration fees.
- When the Food and Drug Administration has received all of the fees owed, they will review the request for information. They will be refunded the user’s fee.
- 513(g) application decision limits to the suggestion on the probable class of the device hence it excludes following:
- Review of data related to substantial equivalence or safety and effectiveness of the product
- Confirmatory note on device classification
- Fda clearance or approval for marketing
- This is specific types of nonclinical, animal, or clinical testing appropriate to support clearance or approval of a marketing application