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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
- Acceptance and filing reviews for premarket approval applications (PMAs): guidance for industry and Food and Drug Administration staff1
- Administrative procedures for CLIA categorization: guidance for industry and Food and Drug Administration staff1
- Center for Devices and Radiological Health appeals processes: questions and answers about 517A : guidance for industry and Food and Drug Administration staff1
- Consideration of uncertainty in making benefit-risk determinations in medical device premarket approvals, de novo classifications, and humanitarian device exemptions: guidance for industry and Food and Drug Administration staff1
- De novo classification process (evaluation of automatic class III designation): guidance for industry and Food and Drug Administration staff1
- 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
- Developing and responding to deficiencies in accordance with the least burdensome provisions: guidance for industry and Food and Drug Administration staff1
- Display devices for diagnostic radiology: guidance for industry and Food and Drug Administration staff1
- FDA medical device reviews: evaluation is needed to assure requests for additional information follow a least burdensome approach : report to Congressional requestors1
- FDA should further integrate its review of cybersecurity into the premarket review process for medical devices1
- Humanitarian device exemption (HDE) program: guidance for industry and Food and Drug Administration staff1
- Laser products: conformance with IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1 : (Laser Notice No. 56) : 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 x-ray imaging devices conformance: guidance for industry and Food and Drug Administration staff1
- Metal expandable biliary stents: premarket notification (510(k)) submissions : 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
- Refuse to accept policy for 510(k)s: guidance for industry and Food and Drug Administration staff1
- Requests for feedback and meetings for medical device submissions: the Q-Submission Program : guidance for industry and Food and Drug Administration staff1