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1. Procedures for meetings of the Medical Devices Advisory Committee: guidance for industry and Food and Drug Administration staff

nlm:nlmuid-101713226-pdf

2. How to prepare a pre-request for designation (pre-RFD)

nlm:nlmuid-101734055-pdf

3. Classification of products as drugs and devices & additional product classification issues: final guidance : guidance for industry and FDA staff

nlm:nlmuid-101719787-pdf

4. De novo classification process (evaluation of automatic class III designation): guidance for industry and Food and Drug Administration staff

nlm:nlmuid-101719887-pdf

5. Unique device identification: policy regarding compliance dates for class I and unclassified devices : immediately in effect guidance for industry and Food and Drug Administration staff

nlm:nlmuid-101720053-pdf

6. Intent to exempt certain unclassified medical devices from premarket notification requirements: guidance for industry and Food and Drug Administration staff

nlm:nlmuid-101759974-pdf

7. Evaluation of devices used with regenerative medicine advanced therapies

nlm:nlmuid-101760001-pdf

8. 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 staff

nlm:nlmuid-101760357-pdf

9. 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 staff

nlm:nlmuid-101760383-pdf