US FDA Labeling Requirements for Medical Devices

Why Should You Attend:

Labels and Labeling. Label for various typeds of products or types of submissions. All can be confusing. The FDA looks very carefully at labeling during both device submissions reviews as well as CGMP compliance audits. Problems in label composition, application, and also in their control, handling, issuance, and reconciliation can get a company quickly in trouble. Review the basics of labels / labeling, and see the various areas of application in this webinar, including some little known or controlled areas which are subject to regulatory scruinty by both the FDA, and even a competitor trying to "level the playing field" with their competition.

FDA medical device labeling requirements are found in several CFRs, i.e.,

• General Device Labeling - 21 CFR Part 801;
• Use of Symbols - 21 CFR Part 801.15;
• In Vitro Diagnostic Products - 21 CFR Part 809;
• Investigational Device Exemptions - 21 CFR Part 812;
• Unique Device Identification - 21CFR Part 830;
• Good Manufacturing Practices - 21 CFR Part 820;
• General Electronic Products - 21 CFR Part 1010.

Add to this the UDI / GUDID requirements, and also court decisions that marketing is labeling. Confusing? This webinar will break these requirements down into the basics and examine means to comply with each category of requirement.

Areas Covered in the Webinar:

• Label vs. Labeling
• Basic CGMPs and Labeling
• Submission categories of labeling.
• Specific required controls.
• On product, on carton, on shipper labels; IFUs
• Shipper labels - their differences
• UDI (and GUDID)
• Product category differentiation
• Marketing and "labeling".

Who Will Benefit:

This webinar will provide valuable assistance to all regulated medical device companies that need to review and ensure their labels / labeling meet current US FDA requirements. The employees who will benefit include:

• Senior management
• Regulatory Affairs
• Quality Assurance
• Production
• Engineering
• Sales and Marketing

John E Lincoln
Principal, J E Lincoln and Associates

John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 41 years experience in U.S. FDA-regulated industries, 27 years as head of his own consulting company. John has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment including QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files. He's held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D). In addition, John has prior experience in military, government, electronics, and aerospace. He has ptublished numerous articles in peer reviewed journals, 5 chapters in the RAPS textbook on validation, conducted workshops and webinars worldwide on CGMP subjects. John is a graduate of UCLA.

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