FDA Supplier Labeling Requirements

E

ElizaB

Registered
#1
#1
Hi all,

I work for a component supplier (not a "component" as the FDA defines it) for several medical device manufacturers. We do not manufacture a finished device but we are ISO 13485 certified.

The only labeling requirements I can think of are that we have a process specified (product and service provision). We review and control the label templates, and we keep records of the labels. Outside of this, any additional labeling requirements would be those imposed by a given customer, right?

Thanks for your time :)
 
How to manage your QMS while working remotely.
Elsmar Forum Sponsor
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
J Sub-supplier change from manual to automated process - same specs - Report to FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
V Determining FDA 820 (registration) vs ISO 13485 - Supplier gives us the kit ISO 13485:2016 - Medical Device Quality Management Systems 1
B Will FDA Inspect a New Coating Supplier for a Class III Combination Medical Device? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
N Where to find a Qualified FDA Supplier Auditor located in China China Medical Device Regulations 7
O FDA - Possibility of visiting a Supplier? US Food and Drug Administration (FDA) 4
B Is there an FDA requirement for a Supplier Audit Schedule US Food and Drug Administration (FDA) 22
H FDA Site generic Supplier Related forms help needed ISO 13485:2016 - Medical Device Quality Management Systems 2
I Developing a ISO/FDA Compliant Supplier Quality Assurance System - Medical Device Supplier Quality Assurance and other Supplier Issues 10
sonflowerinwales FDA approval required for a supplier to a medical device manufacturer? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
A FDA Class Classification for a cabinet 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
L FDA Biocompatibility Requirements - Transitory Contact Other US Medical Device Regulations 1
Edward Reesor FDA DM and /or Class I Life Saving US Food and Drug Administration (FDA) 0
Watchcat FDA will not tolerate fraud…meaning what, exactly? Other US Medical Device Regulations 6
K FDA Premarket Cybersecurity Guidance - 4 questions Other US Medical Device Regulations 2
gunnyshore Form FDA 3500A MedWatch eSubmitter 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
Watchcat FDA Webinar Series - N95 Respirators Other US Medical Device Regulations 0
M Off-Label Use - Clarification of FDA Policy US Food and Drug Administration (FDA) 1
C FDA Establishment registration - Buying some medical devices from another manufacturer Medical Device and FDA Regulations and Standards News 5
I How to classify a medical device based on FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
dinaroxentool Question about FDA Classification of a Device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
S The US FDA requirements on Disposal of a medical device US Food and Drug Administration (FDA) 1
S FDA Requirements for Medical Device Label Reconciliation 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
S What is considered a "core algorithm"? (From an FDA guidance document) Medical Information Technology, Medical Software and Health Informatics 4
B FDA-Medical Device Reporting (MDR )procedure compliant with 21CFR section 803 US Food and Drug Administration (FDA) 0
Stoic Are any medical device companies using the 2011 FDA process validation guidance instead of GHTF/SG3/N99-10:2004? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
D ISO 13485, FDA 21 CFR 820 and Auditing the Accounting Department ISO 13485:2016 - Medical Device Quality Management Systems 5
S FDA's E submitter - For clinical electronic thermometer Medical Device and FDA Regulations and Standards News 6
J FDA wants electrical safety testing on battery powered medical device US Food and Drug Administration (FDA) 8
A FDA and NB audit of Engineering Drawings in DHF and DMR. Medical Device and FDA Regulations and Standards News 1
D FDA De Novo Cover Letter - What is expected US Food and Drug Administration (FDA) 3
Ed Panek 21 CFR Part 820 - FDA Label Requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
J Mislabeling - Consider this an FDA notified recall? CFR 806.10 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
O Hospital-Developed, In-House Device - FDA Clearance? Other US Medical Device Regulations 19
D FDA Approved Class II Medical Device? Other US Medical Device Regulations 11
R When does the FDA consider a component a medical device? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 17
N Risk Management besides mandated FDA requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
M Informational US FDA – Ear, Nose, and Throat Devices; Classification of the Self-Fitting Air-Conduction Hearing Aid Medical Device and FDA Regulations and Standards News 0
L UDI Requirments Gap Analysis - EU MDR vs FDA CFR EU Medical Device Regulations 8
M Informational US FDA – Modifications to the List of Recognized Standards, Recognition List Number: 052 Medical Device and FDA Regulations and Standards News 0
M Informational US FDA Draft Guidance – Breast Implants – Certain Labeling Recommendations to Improve Patient Communication Medical Device and FDA Regulations and Standards News 0
M Looking for third party reviewers for FDA submissions US Food and Drug Administration (FDA) 2
M Informational Work in progress at the FDA for biological evaluation – Color Hazard and RISk calculator (CHRIS) Medical Device and FDA Regulations and Standards News 0
M Informational US FDA – CDRH Proposed Guidances for Fiscal Year 2020 (FY 2020) Medical Device and FDA Regulations and Standards News 0
M Informational US FDA Final Guidance – Coronary, Peripheral, and Neurovascular Guidewires – Performance Tests and Recommended Labeling Medical Device and FDA Regulations and Standards News 0
M Informational US FDA Final Guidance – Intravascular Catheters, Wires, and Delivery Systems with Lubricious Coatings – Labeling Considerations Medical Device and FDA Regulations and Standards News 0
T Clinical trial - Medical device product not cleared (without FDA approval) in a drug trial Other US Medical Device Regulations 9
William55401 How Often Does FDA State Consultant Recommended in a Pharma WL? US Food and Drug Administration (FDA) 1
M Informational US FDA – URGENT/11 Cybersecurity Vulnerabilities in a Widely-Used Third-Party Software Component May Introduce Risks During Use of Certain Medical Dev Medical Device and FDA Regulations and Standards News 0
M Informational US FDA paper – Epidemiological Evidence on the Adverse Health Effects Reports in Relation to Mercury from Dental Amalgam: Systematic Literature Review Medical Device and FDA Regulations and Standards News 0
M Informational US FDA paper – Biological Responses to Metal Implants Medical Device and FDA Regulations and Standards News 0
Similar threads
Top Bottom