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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