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3. Requests for feedback on medical device submissions: the pre-submission program and meetings with Food and Drug Administration staff : guidance for industry and Food and Drug Administration staff

nlm:nlmuid-101719815-pdf

4. Administrative procedures for CLIA categorization: guidance for industry and Food and Drug Administration staff

nlm:nlmuid-101719834-pdf

5. Display devices for diagnostic radiology: guidance for industry and Food and Drug Administration staff

nlm:nlmuid-101719840-pdf

6. Deciding when to submit a 510(k) for a change to an existing device: guidance for Industry and Food and Drug Administration staff

nlm:nlmuid-101719884-pdf

10. FDA should further integrate its review of cybersecurity into the premarket review process for medical devices

nlm:nlmuid-101738136-pdf

14. Medical devices containing materials derived from animal sources (except for in vitro diagnostic devices): guidance for industry and Food and Drug Administration staff

nlm:nlmuid-101760016-pdf

16. 30-Day notices, 135-day premarket approval (PMA) supplements and 75-day humanitarian device exemption (HDE) supplements for manufacturing method or process changes: guidance for industry and Food and Drug Administration staff

nlm:nlmuid-101760040-pdf

18. Utilizing animal studies to evaluate organ preservation devices: guidance for industry and Food and Drug Administration staff

nlm:nlmuid-101760055-pdf

19. Medical x-ray imaging devices conformance: guidance for industry and Food and Drug Administration staff

nlm:nlmuid-101760057-pdf

20. Laser products: conformance with IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1 : (Laser Notice No. 56) : guidance for industry and Food and Drug Administration staff

nlm:nlmuid-101760064-pdf

21. Metal expandable biliary stents: premarket notification (510(k)) submissions : guidance for industry and Food and Drug Administration Staff

nlm:nlmuid-101760276-pdf

22. 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