Reference:USA Acceptance of Clinical Data to Support Medical Device Applications and Submissions Frequently Asked Questions - Guidance for Industry and Food and Drug Administration Staff 21-Feb-2018 -: Difference between revisions
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| | | [[Glossary:TAG-00043-Goo-tek|Good clinical practice]], [[Glossary:TAG-00201-Cli-eSt|Clinical investigation]], [[Glossary:TAG-00155-Med-Med|Medical device]], [[Glossary:TAG-00320-Foo-eri|FDA]] | ||
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Revision as of 17:29, 15 July 2026
| Document information | |
|---|---|
| Reference | USA Acceptance of Clinical Data to Support
Medical Device Applications and Submissions Frequently Asked Questions - Guidance for Industry and Food and Drug Administration Staff 21-Feb-2018 |
| Validity area | USA |
| Scope(s) | MD |
| Document name | Acceptance of Clinical Data to Support
Medical Device Applications and Submissions Frequently Asked Questions - Guidance for Industry and Food and Drug Administration Staff |
| Version / Revision | 21-Feb-2018 |
| Status | Current |
| Document type | Official recommendation |
| Language(s) | EN |
| Description | GUIDANCE DOCUMENT
Acceptance of Clinical Data to Support Medical Device Applications and Submissions: Frequently Asked Questions Guidance for Industry and Food and Drug Administration Staff February 2018 Final Docket Number: FDA-2013-N-0080 Issued by: Center for Biologics Evaluation and Research Center for Devices and Radiological Health |
| Official source | Official link |
| Restricted access | No |
| Submitted by | Florian Adragna |
| Contributors | |
| Reference Details | |
|---|---|
| Module | Module 1 — Unit 1.3.0 |
| Scope | MD |
| Document part | - |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Good clinical practice, Clinical investigation, Medical device, FDA |
| Comment | GCP for medical device clinical investigations (ISO 14155) |
Content
[…] “Clinical Investigation of Medical Devices for Human Subjects—Good Clinical Practice,” ISO 14155:2011, which FDA recognized in 2012 as a consensus standard). […]
