Attention www.globalkeysolutions.net is now www.keypedia.com, read the full press release here.
KeyPedia LogoKeyPedia Icon
Guidance Documents/Guidance-Document/Referencing the Definition of "Device" in the Federal Food, Drug, and Cosmetic Act in Guidance, Regulatory Documents, Communications, and Other Public Documents: Guidance for Industry and Food and Drug Administration Staff

Referencing the Definition of "Device" in the Federal Food, Drug, and Cosmetic Act in Guidance, Regulatory Documents, Communications, and Other Public Documents: Guidance for Industry and Food and Drug Administration Staff

Detailed guidance document from FDA and regulatory agencies.

Document Details

Guidance Document

November 14, 2022

November 10, 2022

Center for Devices and Radiological Health

d129e237-573b-4154-b731-0db0644370be

Related Documents

Providing Regulatory Submissions for Medical Devices in Electronic Format - Submissions Under Section 745A(b) of the Federal Food, Drug, and Cosmetic Act: Guidance for Industry and Food and Drug Administration Staff

Guidance DocumentJuly 15, 2020Center for Devices and Radiological Health
View Details →

Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers: Guidance for Industry and Food and Drug Administration Staff

Guidance DocumentAugust 29, 2024Center for Devices and Radiological Health
View Details →

Content of Premarket Submissions for Device Software Functions: Guidance for Industry and Food and Drug Administration Staff

Guidance DocumentJune 14, 2023Center 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.