Regulatory Focus™ > News Articles > New Medical Device Guidance on Information Requests Released by FDA

New Medical Device Guidance on Information Requests Released by FDA

Posted 05 April 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) released two new guidance documents covering Section 513(g) requests for information issued under the Federal Food, Drug and Cosmetic Act (FD&C Act). Section 513(g) is the means by which industry may obtain FDA's views about the classification and the regulatory requirements for medical devices.

"This guidance describes procedures for the submission, FDA review, and FDA response to requests for information with respect to the classification of a device or the requirements applicable to a device under the FD&C Act that are submitted in accordance with section 513(g) requests for information," writes FDA in the first guidance, entitled Guidance for Industry and Staff: Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act.

FDA's second, related guidance covers the user fees associated with 513(g) requests, which were established under the Medical Device User Fee Amendments (MDUFA) of 2007. That guidance document is entitled, Guidance for Industry and Food and Drug Administration Staff; User Fees for 513(g) Requests for Information.

Both guidance documents should be available in final form on the Center for Devices and Radiologic Health's regulations webpage by 6 April 2012.


Read more:

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

FDA - Guidance for Industry and Food and Drug Administration Staff; User Fees for 513(g) Requests for Information

FDA- CDRH: Recent Medical Device Guidance Documents


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