FDA Guidance

Official FDA guidance documents for medical devices and radiation-emitting products

106 resources
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All Resources FDA Guidance (106) MDCG Guidance (69) Clinical Investigation and Evaluation (17) MDR (15) White Paper (15) New Technologies (7) Borderline and Classification (5) Other / Transition (5) Post-Market Surveillance and Vigilance (4) Notified Bodies (4) UDI (3) Annex XVI Products (3) EU Regulation (2) EUDAMED (2) IVDR (2) Standards (1) Class I Devices (1)
106 resources in FDA Guidance

Presenting Risk Information in Prescription Drug and Medical Device Promotion

FDA Guidance 2009-05-01 FDA Guidance

Draft FDA guidance on labeling. Published 2009 by CDRH/CBER.

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Humanitarian Use Device (HUD) Designations

FDA Guidance 2013-01-01 FDA Guidance

Final FDA guidance on hde. Published 2013 by CDRH/CBER.

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Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials

FDA Guidance 2010-02-01 FDA Guidance

Final FDA guidance on clinical evidence. Published 2010 by CDRH/CBER.

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Modifications to Devices Subject to Premarket Approval (PMA) — PMA Supplement Decision-Making Process

FDA Guidance 2008-12-01 FDA Guidance

Final FDA guidance on pma. Published 2008 by CDRH/CBER.

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Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development

FDA Guidance 2016-02-01 FDA Guidance

Final FDA guidance on human factors. Published 2016 by CDRH/CBER.

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Radio Frequency Wireless Technology in Medical Devices

FDA Guidance 2013-08-01 FDA Guidance

Final FDA guidance on electrical safety. Published 2013 by CDRH/CBER.

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Medical Device Classification Product Codes

FDA Guidance 2013-04-01 FDA Guidance

Final FDA guidance on classification. Published 2013 by CDRH/CBER.

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Providing Information about Pediatric Uses of Medical Devices

FDA Guidance 2014-05-01 FDA Guidance

Final FDA guidance on pediatric devices. Published 2014 by CDRH/CBER.

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Types of Communication During the Review of Medical Device Submissions

FDA Guidance 2014-04-01 FDA Guidance

Final FDA guidance on submission process. Published 2014 by CDRH/CBER.

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Design Considerations for Pivotal Clinical Investigations for Medical Devices

FDA Guidance 2013-11-01 FDA Guidance

Final FDA guidance on clinical evidence. Published 2013 by CDRH/CBER.

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Investigational Device Exemptions (IDEs) for Early Feasibility Medical Device Clinical Studies

FDA Guidance 2013-10-01 FDA Guidance

Final FDA guidance on ide. Published 2013 by CDRH/CBER.

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Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling

FDA Guidance 2015-03-01 FDA Guidance

Final FDA guidance on labeling. Published 2015 by CDRH/CBER.

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Design Considerations for Devices Intended for Home Use

FDA Guidance 2014-11-01 FDA Guidance

Final FDA guidance on design controls. Published 2014 by CDRH/CBER.

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FDA Decisions for Investigational Device Exemption Clinical Investigations

FDA Guidance 2014-08-01 FDA Guidance

Final FDA guidance on ide. Published 2014 by CDRH/CBER.

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In Vitro Companion Diagnostic Devices

FDA Guidance 2014-08-01 FDA Guidance

Final FDA guidance on ivd & diagnostics. Published 2014 by CDRH/CBER.

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Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval

FDA Guidance 2015-04-01 FDA Guidance

Final FDA guidance on pma. Published 2015 by CDRH/CBER.

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Patient Preference Information — Voluntary Submission and Review in PMA/HDE/De Novo

FDA Guidance 2016-08-01 FDA Guidance

Final FDA guidance on patient engagement. Published 2016 by CDRH/CBER.

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Adaptive Designs for Medical Device Clinical Studies

FDA Guidance 2016-07-01 FDA Guidance

Final FDA guidance on clinical evidence. Published 2016 by CDRH/CBER.

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Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices

FDA Guidance 2016-06-01 FDA Guidance

Final FDA guidance on pediatric devices. Published 2016 by CDRH/CBER.

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Evaluation and Reporting of Age-, Race-, and Ethnicity-Specific Data in Medical Device Clinical Studies

FDA Guidance 2017-09-01 FDA Guidance

Final FDA guidance on clinical evidence. Published 2017 by CDRH/CBER.

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Design Considerations and Premarket Submission Recommendations for Interoperable Medical Devices

FDA Guidance 2017-09-01 FDA Guidance

Final FDA guidance on interoperability. Published 2017 by CDRH/CBER.

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Factors to Consider When Making Benefit-Risk Determinations for Medical Device IDEs

FDA Guidance 2017-01-01 FDA Guidance

Final FDA guidance on ide. Published 2017 by CDRH/CBER.

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Postmarket Management of Cybersecurity in Medical Devices

FDA Guidance 2016-12-01 FDA Guidance

Final FDA guidance on cybersecurity. Published 2016 by CDRH/CBER.

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FDA and Industry Actions on PMA Submissions: Effect on FDA Review Clock and Goals

FDA Guidance 2017-10-01 FDA Guidance

Final FDA guidance on pma. Published 2017 by CDRH/CBER.

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