Attention www.globalkeysolutions.net is now www.keypedia.com, read the full press release here.
KeyPedia LogoKeyPedia Icon
Guidance Documents/Guidance-Document/Evaluation and Reporting of Age-, Race-, and Ethnicity-Specific Data in Medical Device Clinical Studies: Guidance for Industry and Food and Drug Administration Staff

Evaluation and Reporting of Age-, Race-, and Ethnicity-Specific Data in Medical Device Clinical Studies: Guidance for Industry and Food and Drug Administration Staff

Detailed guidance document from FDA and regulatory agencies.

Document Details

Guidance Document

September 12, 2017

April 8, 2024

Center for Devices and Radiological Health

9fb9098f-5c24-4238-a9d8-64a10ae06702

Related Documents

Acceptance of Clinical Data to Support Medical Device Applications and Submissions: Frequently Asked Questions: Guidance for Industry and Food and Drug Administration Staff

Guidance DocumentFebruary 21, 2018Center for Devices and Radiological Health
View Details →

Deciding When to Submit a 510(k) for a Change to an Existing Device: Guidance for Industry and Food and Drug Administration Staff

Guidance DocumentOctober 25, 2017Center for Devices and Radiological Health
View Details →

Evaluation of Sex-Specific Data in Medical Device Clinical Studies - Guidance for Industry and Food and Drug Administration Staff

Guidance DocumentMarch 31, 2025Center for Devices and Radiological Health
View Details →

Quick Actions

Your cart

Your cart is empty.

Browse public document pages and click Buy this document. We'll ask for your email at checkout, no account needed up front.

Browse documents

Transform Regulatory Data into Actionable Intelligence

Join leading pharmaceutical and medical device companies who trust KeyPedia for their regulatory compliance needs.

KeyPedia
Regulatory Data Transformed
Stay in the loop

KRA score changes, company updates and news. About monthly, unsubscribe anytime.

Contact
New York Office:
370 Jay Street 7th Floor
Brooklyn, NY 11201
Scranton Office:
Scranton Enterprise Center, Suite 217
201 Lackawanna Avenue
Scranton, PA, 18503
🇺🇸+1 917-789-5099
🇪🇺+48 532-447-507
info@keypedia.com
Quick Links
HomePlatform OverviewMedia
KeyPedia™ Lite
Browse HubDatabase DirectoryRecordsCompaniesOfficesPeopleCareersAbout UsFounding TeamMeet Our ExpertsPartners
Legal & Ethics
Privacy PolicyTerms of ServiceOur Values & MissionCode of Ethics & AI Policy
©2026 KeyPedia™ | Global Key Solutions Corp. All rights reserved.