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| Guidance on Requesting FDA Info on Device Classification |
| 04/06/2012 |
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Federal Register Notice: FDA is making available, Guidance for Industry and Food and Drug Administration Staff; FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act. It establishes the procedures for the submission, FDA review, and FDA response to requests for information on the class in which a device has been classified. To download this guidance, click here. To view this notice, click here. |
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