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FDA Submits Info on 513(g) Requests to OMB


Federal Register Notice: FDA’s proposed collection of information, “513(g) Request for Information,” has been submitted to the Office of Management and Budget for review and clearance under the Paperwork Reduction Act of 1995. Section 513(g) of the FD&C Act provides a means for obtaining FDA’s views about the classification and regulatory requirements that may be applicable to a particular device. It also provides that, within 60 days of the receipt of a written request of any person for information on the class in which a device has been classified or the requirements applicable to a device shall provide such person a written statement of the classification (if any) of such device and the requirements of the FD&C Act applicable to the device. To view this notice, click here.