Webinar Medical Device Changes and the 510(k)

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Webinar On Webinar On Medical Device Changes and
the 510(k)

Presented
By John E. Lincoln
Tuesday, March 31, 2015 at 1300 Hrs
Hosting By Compliance Trainings
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Webinar On Medical Device Changes and the 510(k)
Product Id
MD1541
Category
Medical Devices
Scheduled On
Tuesday, March 31, 2015 at 1300 Hrs
Duration
90 Minutes
Speaker
John E. Lincoln
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Webinar Description
This webinar will provide valuable guidance to
regulated companies in development and
implementation of formal, defined, documented
methods for analysis of product changes and when
to file a new 510(k). Consideration of the U.S.
FDA's current K-97-1 Memo / guidance document on
"510(k) Device Modifications Control of medical
device changes and a current 510(k) are big
issues in recent FDA studies. Companies are held
fully responsible for deciding when a new 510(k)
filing is warranted. Often this is a difficult
decision process.  Effective change control and
the power of current risk management tools must
be a major part of such an analysis. The U.S. FDA
has its current K-97-1 Memorandum (they recently
pulled their proposed new draft Guidance
Document, "510(k) Device Modifications Deciding
When to Submit a 510(k) for a Change to an
Existing Device"). K97-1 provides a tool to
assist in device and new 510(k) / change
analysis. The addition of such simple tools will
assist companies in implementing formal,
documented, repeatable methods with defensible
rationale for their decisions on when changes
trigger the need for a new 510(k) submission.
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The K97-1 analysis is the preferable tool to work
with a company's change control system to
document the need to file, or the rationale for
not submitting a 510(k). It is recommended as the
preferred method for documentation of each change
in a device during its lifecycle. Provides for a
Step-by-step analysis Manufacturing, Labeling,
Tech / Performance, and/or Materials Changes.
Consideration of which of the three major 510(k)
formats should be used Traditional, Special or
Abbreviated.
Areas Covered in the Session

• 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
  current Guidance on 510(k) Device Modifications.
  This session will cover
• Deciding When to Submit a 510(k) for a Change to
  an Existing Device, K97-1
• How to provide tools to document such decisions
• It will discuss how companies can best document
  their decisions -- whether or not a new 510(k)
  filing is warranted
• How to structure a decision matrix to document
  change decisions
• How to evaluate changes that could trigger the
  "Tipping Point"
• Who makes the decisions and how to defend them
• How to implement formal methods with documented,
  and defensible rationale
• Preparing for further 510(k) changes in the
  future

Who will Benefit

• This webinar is a must for companies in the
  Medical Device and combination products fields.
  The employees who will benefit include
• Research Development
• Engineering Staff
• Quality Assurance

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• Regulatory Affairs
• Lean Six Sigma staff
• New Product Development
• Marketing
• Mid-level and Senior Management
• Project Leaders
• Consultants

Speaker Profile
John E. Lincoln, is Principal of J. E. Lincoln
and Associates LLC, a consulting company with
over 33 years experience in U.S. FDA-regulated
industries, 19 years as a full-time consultant.
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 has held positions in
Manufacturing Engineering, QA, QAE, Regulatory
Affairs, to the level of Director and VP (RD).
In addition, John has prior experience in
military, government, electronics, and aerospace.
He has ptublished numerous articles in peer
reviewed journals, conducted workshops and
webinars worldwide on CGMP subjects. John is a
graduate of UCLA.
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DetailView.aspx?idMD1541
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