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

OMB 0910-0705

OMB 0910-0705

This ICR collects information from manufacturers who wish to obtain information from FDA regarding the classification and regulatory requirements that may be applicable to their individual device. Under section 513 of the Federal Food, Drug, and Cosmetic Act, devices are classified by the regulatory controls needed to provide a reasonable assurance of their safety and effectiveness. FDA classifies these devices into class I (general controls), class II (special controls), or class III (premarket approval). Under section 513(g), within 60 days of receipt of a written request for information respecting the class in which a device has been classified or the requirements applicable to a device under the act, FDA will provide a written statement of classification (if any) of such device and the requirements of this act applicable to the device.

The latest form for Guidance FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act expires 2021-06-30 and can be found here.

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CDRH 513(g) Requests

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