Web Address or the Full Street and ZIP/Postcode Address for FPR Labeling?

Q

QARKM

#1
For CE and FDA do I need the full street and ZIP/Postcode address on a medical device label or does a web address suffice?
 
Elsmar Forum Sponsor

chris1price

Trusted Information Resource
#2
Hi

For Europe, it should be a postal address, with sufficient detail to allow a letter to be delivered. In UK, a company name, postcode and country will often be sufficient.

I dont think a Web or email address is acceptable for any regulatory body.

Chris
 
L

Laura Halper

#3
Hi QARKM,
The FDA requirements for the U.S. are found in 21CFR 801.1(d):

"The statement of the place of business shall include the street address, city, State, and Zip Code; however, the street address may be omitted if it is shown in a current city directory or telephone directory...."

So just website or email address is not acceptable in the U.S., either.

Regards,
Laura
 
Thread starter Similar threads Forum Replies Date
B Do you use paper or web-based templates for CAPA processes? ISO 13485:2016 - Medical Device Quality Management Systems 3
C Software validation - Off The Shelf Software - Web hosted ISO 13485:2016 - Medical Device Quality Management Systems 6
S IFU on web page - Consequences if the most recent one is not uploaded EU Medical Device Regulations 3
K Need feedback: FMEA Web Application FMEA and Control Plans 5
G Web based tool for benchmarking audit findings Benchmarking 6
C Web based Complaint Software which interfaces with our Enovia system Document Control Systems, Procedures, Forms and Templates 0
G Nonconformance Categories - QMS web app to support ISO9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
F Looking for some type of training on Lean Manufacturing video or web training Lean in Manufacturing and Service Industries 7
T Changes on the Medical Devices Act in Korea announced on MFDS web site Other Medical Device Regulations World-Wide 1
P For any programmers in the Cove - Web based ISO System? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
T Web-based Software Device - Servers & 510k 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
S Web Based Training System recommendations wanted Training - Internal, External, Online and Distance Learning 3
renenatasha Usage of web articles in DHF (Design History File) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 10
WCHorn New Web Site Tab Required Coffee Break and Water Cooler Discussions 4
J Web based Database to Collect and Evaluate 5S Audit Results, Trends, Charts Lean in Manufacturing and Service Industries 3
Q 21 CFR Part 11 Password Requirement for a Web Service Software Quality Assurance 6
J Is ASQ CQM/OE web-based training worth it? Training - Internal, External, Online and Distance Learning 4
T How do I control web-based asp forms/rpts that write to and pull from an Access DB Document Control Systems, Procedures, Forms and Templates 4
W Lean Games and Simulations Web Site Lean in Manufacturing and Service Industries 0
P Web based file sharing i.e. Dropbox for Doc Control - Comments/Alternatives? Document Control Systems, Procedures, Forms and Templates 6
Marc 6 August 1991 - First page on the World Wide Web publicly available After Work and Weekend Discussion Topics 0
L Data Management and Web based Document Control Software Document Control Systems, Procedures, Forms and Templates 18
C FDA Labeling Requirements and Company Brochures and Web Site Content US Food and Drug Administration (FDA) 5
S FDA Inspection Guide to MD - New Web Portal for Inspectional Database US Food and Drug Administration (FDA) 1
AnaMariaVR2 FDA launches consumer-friendly Web search for recalls US Food and Drug Administration (FDA) 0
J New Toyota Supplier Quality Manual is on the Toyota Web Site Customer and Company Specific Requirements 1
K Seeking a workflow for web based Document Control System Document Control Systems, Procedures, Forms and Templates 4
Marc Justice Department seeks to have all web surfing tracked After Work and Weekend Discussion Topics 19
C World Population Clock as Web Part in SharePoint Document Control Systems, Procedures, Forms and Templates 1
F Document Control - Addressing control of content stored on web sites Document Control Systems, Procedures, Forms and Templates 9
G Is it dumb to develop an ISO 17025 web site? ISO 17025 related Discussions 9
P Standards Subscription - Online web site that provides AMS, NAS, SAE etc, standards Various Other Specifications, Standards, and related Requirements 1
bio_subbu USFDA CDER Learn (Web based course free of charge) Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 1
J One of the great web comics of all time - xkcd Funny Stuff - Jokes and Humour 6
Marc My Cousin Jonny's Art Web Site - Camp Ernst Pictures Coffee Break and Water Cooler Discussions 7
J FDA Launches Medical Device and Radiation-Emitting Product Transparency Web site US Food and Drug Administration (FDA) 2
somashekar Substances declarations web database for REACH, RoHS, Book, Video, Blog and Web Site Reviews and Recommendations 2
S Sharing information on useful web sites Book, Video, Blog and Web Site Reviews and Recommendations 30
K Paperless Web Based Quality System Quality Assurance and Compliance Software Tools and Solutions 11
GStough Verisys Registrars - Interesting Statements on Their Web Site Registrars and Notified Bodies 2
A Learning Excel - Web Site, Book, and Add-in Recommendations Excel .xls Spreadsheet Templates and Tools 6
D The best web sites to learn about IMDS information and enter information? RoHS, REACH, ELV, IMDS and Restricted Substances 3
Marc China has more Web users than US has citizens After Work and Weekend Discussion Topics 2
V Engineering Calculations web site Book, Video, Blog and Web Site Reviews and Recommendations 1
J Off the shelf design - Web & Graphic design agency Design and Development of Products and Processes 3
Marc Belkin is paying for positive Web reviews After Work and Weekend Discussion Topics 7
Howard Atkins New IATF (International Automotive Task Force) web site IATF 16949 - Automotive Quality Systems Standard 26
Marc If the Elsmar Cove Forums and Web Site was Yours, What would you do to Improve? Forum News and General Information 59
Jen Kirley Stuck in the eBay help desk spider web! Service Industry Specific Topics 13
W Copyright - Links in Posts Leading to Copyrighted Material on Other Web Sites Elsmar Cove Forum ToS and Forum Policies 25

Similar threads

Top Bottom