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FDA 513(g) Requests Procedures Information Guidance

Aug 3 2022

The 513(g) Request is for the medical device manufacturers who submitting, reviewing, and responding to classify particular devices it is difficult to determine the class of devices appropriately.

After you submit the 513(g) requests, you will receive a response from FDA within 60 days for your particular device. FDA will generally provide the following information regarding device classification and applicable FDA regulatory requirements:

  • the agency's assessment, based on the information submitted in the request, as to the generic type of device (e.g., classification regulation) that the requester's device appears to be within (if any);

  • the class of devices within that generic type (and if there is more than one class within that generic type, the particular class within which the requestor's device appears to fall);

  • whether a PMA, 510(k), or neither is required in order to market devices of the particular class within that generic type;

  • other requirements applicable to devices of the particular class within that generic type;

  • whether a guidance document has been issued regarding the exercise of enforcement discretion over the particular class of devices within that generic type;

  • whether additional FDA requirements may apply, such as those applicable to radiation-emitting products.

FDA does not review data related to substantial equivalence or safety and effectiveness in a 513(g) Request for Information. FDA's responses to 513(g) Requests for Information are not device classification decisions and do not constitute FDA clearance or approval for marketing. Classification decisions and clearance or approval for marketing require submissions under different sections of the FD&C Act. The most common method of seeking a classification decision is to submit a premarket notification in accordance with Contains Nonbinding Recommendations 14 section 510(k) of the FD&C Act (see 21 CFR part 807, subpart E - Premarket Notification Procedures).

The 513(g) Request for Information should contain the following:

  • Cover letter: Date of the request, Company name, Contact person, Contact information (email and phone number)

  • Device description: Brief description, Describe the mechanism of action, Describe the disease or condition the device is intended for, Include picture or schematic, if available, Patient population

  • Intended Use: Describe what the device is used for, Physiological purpose

  • Labeling Claims: Promotional claims beyond the intended use

Responding to a 513(g) Request for information :

  • a device within the meaning of section 201(h) of the FD&C Act, your device appears to be within, the class of device within which your device appears to fall, and the type of submission, if any, required in order to market devices of the particular class within that generic type:

  1. Class I or II subject to the 510(k) requirement

  2. Class I or II exempts from the 510(k) requirement

  3. Class III subject to the 510(k) or PMA requirements

  • not a device

  1. but may be another type of product regulated by FDA. In this case, we would provide you with contact information for another component within FDA

  2. and appears not to be a product for which FDA has jurisdiction

  • a combination product where it is not clear which Center has primary jurisdiction. If you would like to discuss further the assignment of this product, we recommend you contact the Office of Combination Products.

  • 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

If FDA does not receive a response within 30 days of our request, we may consider a 513(g) to be withdrawn. In this instance, FDA may issue a notice of withdrawal.

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