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15 CFR 748.3 - Classification requests and advisory opinions.
(2) When submitting a classification request, you must complete Blocks 1 through 5, 14, 22(a), (b), (c), (d), and (i), 24, and 25 on the application.
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Medical Device Classification Procedures
classification and reclassification requests submitted submitting FDA forms that currently accompany classification or reclassification petitions are $4755.
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Classification Request Guidelines
The guidelines below identify some common problems with or omissions from commodity classification requests and suggest steps you can take to avoid them.
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