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Titles
- Classification of products as drugs and devices & additional product classification issues: final guidance : guidance for industry and FDA staff1
- Consideration of uncertainty in making benefit-risk determinations in medical device premarket approvals, de novo classifications, and humanitarian device exemptions: guidance for industry and Food and Drug Administration staff1
- De novo classification process (evaluation of automatic class III designation): guidance for industry and Food and Drug Administration staff1
- Evaluation of devices used with regenerative medicine advanced therapies1
- Factors to consider when making benefit-risk determinations in medical device premarket approval and de novo classifications: guidance for industry and Food and Drug Administration staff1
- How to prepare a pre-request for designation (pre-RFD)1
- Intent to exempt certain unclassified medical devices from premarket notification requirements: guidance for industry and Food and Drug Administration staff1
- Procedures for meetings of the Medical Devices Advisory Committee: guidance for industry and Food and Drug Administration staff1
- Unique device identification: policy regarding compliance dates for class I and unclassified devices : immediately in effect guidance for industry and Food and Drug Administration staff1