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Titles
- Content of premarket submissions for device software functions: guidance for industry and Food and Drug Administration staff1
- Deciding when to submit a 510(k) for a software change to an existing device: guidance for industry and Food and Drug Administration staff1
- Display devices for diagnostic radiology: guidance for industry and Food and Drug Administration staff1
- FDA should further integrate its review of cybersecurity into the premarket review process for medical devices1
- Software as a medical device (SAMD): clinical evaluation : guidance for industry and Food and Drug Administration staff1
- Technical considerations for additive manufactured medical devices: guidance for industry and Food and Drug Administration staff1