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Start Over You searched for: Subjects Equipment and Supplies -- standards Remove constraint Subjects: Equipment and Supplies -- standards Dates by Range 2000 and later Remove constraint Dates by Range: 2000 and later

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

2. Medical product communications that are consistent with the FDA-required labeling: questions and answers

3. Appropriate use of voluntary consensus standards in premarket submissions for medical devices: guidance for industry and Food and Drug Administration staff

4. Design considerations and pre-market submission recommendations for interoperable medical devices: guidance for industry and Food and Drug Administration staff

5. Manufacturers sharing patient-specific information from medical devices with patients upon request: guidance for industry and Food and Drug Administration staff

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

7. Software as a medical device (SAMD): clinical evaluation : guidance for industry and Food and Drug Administration staff

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

9. Recognition and withdrawal of voluntary consensus standards: guidance for industry and Food and Drug Administration staff

10. Use of International Standard ISO 10993-1: "Biological evaluation of medical devices - part 1 : evaluation and testing within a risk management process" : guidance for industry and Food and Drug Administration staff