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Start Over You searched for: Formats Text Remove constraint Formats: Text Copyright Public domain Remove constraint Copyright: Public domain Subjects United States. Food and Drug Administration. Remove constraint Subjects: United States. Food and Drug Administration. Subjects Device Approval -- standards Remove constraint Subjects: Device Approval -- standards Genre Technical Report Remove constraint Genre: Technical Report
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1. Center for Devices and Radiological Health appeals processes: questions and answers about 517A : guidance for industry and Food and Drug Administration staff

nlm:nlmuid-101719809-pdf

2. Developing and responding to deficiencies in accordance with the least burdensome provisions: guidance for industry and Food and Drug Administration staff

nlm:nlmuid-101719811-pdf

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

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

nlm:nlmuid-101719885-pdf

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

nlm:nlmuid-101719887-pdf

9. Unique device identification: direct marking of devices : guidance for Industry and Food and Drug administration staff

nlm:nlmuid-101719980-pdf

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

nlm:nlmuid-101738136-pdf

11. FDA medical device reviews: evaluation is needed to assure requests for additional information follow a least burdensome approach : report to Congressional requestors

nlm:nlmuid-101746270-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

15. Recommended content and format of non-clinical bench performance testing information in premarket submissions: guidance for industry and Food and Drug Administration staff

nlm:nlmuid-101760027-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

17. Requests for feedback and meetings for medical device submissions: the Q-Submission Program : guidance for industry and Food and Drug Administration staff

nlm:nlmuid-101760051-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