Attention www.globalkeysolutions.net is now www.keypedia.com, read the full press release here.
KeyPedia LogoKeyPedia Icon
Guidance Documents/Guidance-Document/Medical Device Reporting for Manufacturers : Guidance for Industry and Food and Drug Administration Staff

Medical Device Reporting for Manufacturers : Guidance for Industry and Food and Drug Administration Staff

Detailed guidance document from FDA and regulatory agencies.

Document Details

Guidance Document

November 8, 2016

February 9, 2019

Center for Devices and Radiological Health

bdf0f904-24f2-44f0-8046-74c1e429237a

Related Documents

M4Q(R2) The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality

Guidance DocumentJanuary 20, 2026Center for Drug Evaluation and Research
View Details →

CPG Sec 335700 Surgeons' Gloves and Patient Examination Gloves; Defects - Criteria for Direct Reference Seizure

Guidance DocumentMarch 1, 2011Center for Devices and Radiological Health
View Details →

Software as a Medical Device (SAMD): Clinical Evaluation: Guidance for Industry and Food and Drug Administration Staff

Guidance DocumentDecember 8, 2017Center 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.