Free Labeling

Much can be learned by reading “other Company” medical device labeling and promotional materials

– particularly Instructions For Use (IFUs) and other safety-related information. The IFUs of your competitors or quasi-competitors are excellent tools to facilitate product development and risk management. However, when it comes to finding labeling content on the internet, beggars cannot be choosers. Here is what this beggar has found so far:

Boston Scientific Products
Keep clicking and you should find “Prescriptive Information” and sometimes “Directions For Use”. You can even sign up for email updates when the “DFU” is revised.

How helpful!

Cook Medical

CR Bard

No IFUs – just general product information.

ev3/Covidien Product Catalogs

ev3/Covidien “Peripheral” Products (brochures/IFUs)
For IFUs, click until you see “Resources” at bottom right of screen.

Johnson & Johnson e-IFUs
JNJ Cordis IFUs
Bulls-eye! Nice simple drop-down!

Good stuff!

No IFUs, mostly product listings, but for neuro products keep clicking and you should find “Prescriptive Info”.

Stryker Reprocessed Device IFUs

St. Jude Medical
Click on “Products” page you are interested in. Keep clicking and you should find “Product Overview” and below that “Indications, Contraindications, Warnings, Precautions & Potential Adverse Events”.

Cool graphics, product information, surgical technique guides, etc.

Published by Sam Lazzara

Sam Lazzara is a Biomedical Engineer (MS Case Western, BS Brown University) and Certified Biomedical Auditor with 30+ years medical device experience. Sam’s systems and documents have delighted dozens of regulatory auditors from the United States FDA, the California Department of Health, and a flock of European Notified Bodies. He has guided quality system implementation for over 20 firms, leading to third-party certification and government approvals. A medical device start-up specialist, Sam provides state-of-the-art solutions tailored to the needs of each client. He mentors clients on all aspects of quality assurance and regulatory affairs. Sam gets particularly excited about design control, risk management, and post-market surveillance.

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