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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{{:Document: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}} | {{:Document: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}} | ||
{| class="gplx-infobox" | |||
{| class=" | |||
|- | |- | ||
! | ! colspan="2" class="gplx-infobox-header" | Reference Details | ||
|- | |||
! Scope | |||
| MD | | MD | ||
|- | |- | ||
! | ! Document part | ||
| - | | - | ||
|- | |- | ||
! | ! Language | ||
| EN | | EN | ||
|- | |- | ||
! | ! Original entry by | ||
| Florian Adragna | | Florian Adragna | ||
|- | |- | ||
! | ! Contributors | ||
| | | | ||
|- | |- | ||
! | ! Tags (EN) | ||
| | | | ||
|- | |- | ||
! | ! Tags (original language) | ||
| | | | ||
|- | |- | ||
! | ! Tags (FR) | ||
| | | | ||
|- | |- | ||
! | ! Comment | ||
| GCP for medical device clinical investigations (ISO 14155) | | 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). | “Clinical Investigation of Medical Devices for Human Subjects—Good Clinical Practice,” ISO 14155:2011, which FDA recognized in 2012 as a consensus standard). | ||
[…] | […] | ||
Revision as of 14:27, 29 June 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 | |
|---|---|
| Scope | MD |
| Document part | - |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags (EN) | |
| Tags (original language) | |
| Tags (FR) | |
| 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). […]
