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Titles
- Deciding when to submit a 510(k) for a change to an existing device: 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
- Design considerations and pre-market submission recommendations for interoperable medical devices: 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
- Pediatric information for x-ray imaging device premarket notifications: guidance for industry and Food and Drug Administration staff1
- Product labeling for certain ultrasonic surgical aspirator devices: guidance for Industry and Food and Drug Administration staff1