The FDA's New Draft Guidance on Medical Device Change(s) and the 510(k)

Instructor: John E Lincoln
Product ID: 702100
  • Duration: 90 Min

recorded version

1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Oct-2011

Training CD / USB Drive

One CD/USB is for usage in one location only.
(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-362-2367


Read Frequently Asked Questions

This training on FDA's new Draft Guidance will discuss how companies can best document their decision when a new 510(k) filing is warranted. It will assist in the implementation of formal methods with documented, and defensible rationale; which will also prepare industry for further 510(k) changes in the future.

Why Should You Attend:

The FDA has published a New Draft Guidance Document, "510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device", on July 27, 2011, that shows how companies are to perform meaningful, results driven 510(k) / change analysis activities. However, companies are not yet fully utilizing the power of current risk management tools, which must be a part of such an analysis.

This webinar will provide valuable guidance to regulated companies in development and implementation of Product Risk Management Planning. It will expand this tool into training, marketing, validation, root cause analysis, CAPA / failure investigations, GMP auditing, and liability reduction. Regular use of these few simple but powerful tools in a Product Risk Management File and Report template can contribute greatly to reduction of product liability, company-wide cost reduction efforts, less chance of recalls, and an improved bottom line.

Areas Covered in the Seminar:

  • Key requirements of the new Draft Guidance on Changes and the 510(k).
  • Fully capture your device change control process.
  • Expected sources of information for evaluation and inclusion.
  • Two approaches to the use of FDA's K97-1 Memo.
  • Step-by-step analysis: Manufacturing, Labeling, Tech / Performance, and/or Materials Changes.
  • Change reporting "tipping point" -- with one change or cumulative.
  • Which of the three major 510(k) formats should be used.
  • How to complete, document and control as a 'living' document.

Who Will Benefit:

This webinar will provide valuable assistance to all regulated companies performing and documenting meaningful, results driven 510(k) / change analysis activities, based on the FDA's new Draft Guidance, "510(k) Device Modifications:  Deciding When to Submit a 510(k) for a Change to an Existing Device", dated July 27, 2011.

The employees who will benefit include:

  • Senior management
  • Regulatory Affairs
  • Quality Assurance
  • Production
  • R&D and Engineering
  • All personnel tasked with product hazard reduction and problem solving

Instructor Profile:

John E. Lincoln , is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 29 years experience in U.S. FDA-regulated industries, 16 years as a full-time consultant. John has worked with companies from start-up o 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 published numerous articles in peer reviewed journals, conducted workshops and webinars worldwide on all CGMP subjects.   John is a graduate of UCLA.

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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

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