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Titles
- Medical devices3
- Peripheral vascular atherectomy devices: premarket notification [510(k)] submissions : guidance for industry and Food and Drug Administration staff2
- 510(k) third party review program: guidance for industry, Food and Drug Administration staff, and third party review organizations1
- Application of human factors engineering principles for combination products: questions and answers : guidance for industry and FDA staff1
- Appropriate use of voluntary consensus standards in premarket submissions for medical devices: guidance for industry and Food and Drug Administration staff1
- Arthroscopy pump tubing sets intended for multiple patient use - Premarket Notification (510(k)) submissions: guidance for industry and Food and Drug Administration staff1
- Assessing the credibility of computational modeling and simulation in medical device submissions: guidance for industry and Food and Drug Administration staff1
- Bone anchors: premarket notification (510(k)) submissions : guidance for industry and Food and Drug Administration staff1
- Breakthrough Devices Program: guidance for industry and Food and Drug Administration staff1
- Center for Devices and Radiological Health (CDRH) appeals processes: questions and answers about 517A : guidance for industry and Food and Drug Administration staff1
- Computer-assisted detection devices applied to radiology images and radiology device data: premarket notification [510(k)] submissions : guidance for industry and Food and Drug Administration staff1
- Conduct of clinical trials of medical products during the COVID-19 public health emergency: guidance for industry, investigators, and institutional review boards1
- Considerations for the development of dried plasma products intended for transfusion1
- Content of premarket submissions for device software functions: guidance for industry and Food and Drug Administration staff1
- Coordinated development of antimicrobial drugs and antimicrobial susceptibility test devices: guidance for industry and Food and Drug Administration staff1
- Cybersecurity in medical devices: quality system considerations and content of premarket submissions : guidance for industry and Food and Drug Administration staff1
- Cybersecurity in medical devices: refuse to accept policy for cyber devices and related systems under section 524B of the FD&C Act : guidance for industry and Food and Drug Administration staff1
- Effects of the COVID-19 public health emergency on formal meetings and user fee applications for medical devices: questions and answers (revised) : guidance for industry and Food and Drug Administration staff1
- Electronic submission template for medical device 510(k) submissions: guidance for industry and Food and Drug Administration staff1
- Emergency use authorization of medical products and related authorities: guidance for industry and other stakeholders1