« Previous
Next »
Titles
- 30-Day notices, 135-day premarket approval (PMA) supplements and 75-day humanitarian device exemption (HDE) supplements for manufacturing method or process changes: guidance for industry and Food and Drug Administration staff1
- Appropriate use of voluntary consensus standards in premarket submissions for medical devices: guidance for industry and Food and Drug Administration staff1
- Basal metabolism apparatus: items 4020006, 4020008, 40200121
- Changes to existing medical software policies resulting from section 3060 of the 21st Century Cures Act: 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
- Final report on Project no. 41 -- physiological and operational characteristics of tank T25E11
- Manufacturers sharing patient-specific information from medical devices with patients upon request: guidance for industry and Food and Drug Administration staff1
- Medical devices containing materials derived from animal sources (except for in vitro diagnostic devices): guidance for industry and Food and Drug Administration staff1
- Medical product communications that are consistent with the FDA-required labeling: questions and answers1
- Process to request a review of FDA's decision not to issue certain export certificates for devices: guidance for industry and Food and Drug Administration staff1
- Recognition and withdrawal of voluntary consensus standards: guidance for industry and Food and Drug Administration staff1
- Recommended content and format of non-clinical bench performance testing information in premarket submissions: guidance for industry and Food and Drug Administration staff1
- Software as a medical device (SAMD): clinical evaluation : guidance for industry and Food and Drug Administration staff1
- Unique device identification: convenience kits : guidance for industry and Food and Drug Administration staff1
- Unique device identification: direct marking of devices : guidance for Industry and Food and Drug administration staff1
- 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 staff1
- 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 staff1