ComplianceOnline

Selecting the Most Appropriate Predicate Device(S) for your 510(k) Application

Instructor: Cheryl Wagoner
Product ID: 703438
  • Duration: 60 Min

recorded version

$229.00
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Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Jun-2014

Training CD

$399.00
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CD and Ref. material will be shipped within 15 business days

Customer Care

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Read Frequently Asked Questions

This webinar will provide tips and techniques on how to research and identify appropriate predicate devices for a 510(k) application.

Why Should You Attend:

The goal of a 510(k) application is to demonstrate substantial equivalence. Historically, it was common to use multiple predicates to show substantial equivalence of a new device. More and more, it is preferable to rely on a single predicate or at least the fewest number possible. It is still appropriate at times to have multiple predicates, but one must exercise caution in order to not give the impression the subject device is not very similar to other marketed devices.

This webinar will discuss search techniques for identifying appropriate predicates for a 510(k) application. It will provide tips and techniques on how to determine a predicate or multiple predicates that are suitable for supporting a decision of substantial equivalence.

Areas Covered in the Webinar:

  • What should be the basis of the predicate?
  • When is it appropriate to have multiple predicates?
  • When is it not appropriate to have multiple predicates?
  • You must have head-to-head comparative test data?
  • How can I use standards to demonstrate equivalency?
  • Search tips for identifying a predicate for your device.
  • How do you get enough information to determine if your device is substantially equivalent?

Who Will Benefit:

  • Regulatory Managers or Project Managers
  • Regulatory Specialists who Compose 510(k) Applications
  • Product Development Managers or Project Managers
  • Quality Systems Personnel
  • Engineering/R&D/Technical Services

Instructor Profile:

Cheryl Wagoner, has 20 years of experience in quality assurance, and regulatory affairs. She currently is the Principal Consultant/Owner of Wagoner Consulting LLC, where she provides consulting services to medical device and pharmaceutical companies. Previously, she has held various positions in Quality, Regulatory, Clinical and Compliance in the medical device and pharmaceutical industries.

Cheryl is a member of Regulatory Affairs Professionals (RAPS), Association for the Advancement of Medical Instrumentation (AAMI), Medical Device Manufacturers (MDMA) FDA Working Group, and the MDMA Compliance Working Group. She completed the RAPS Executive Development Program at the Kellogg School of Management.

Follow us :
Upcoming In-person Seminars by EX-FDA OFFICIALS
CLIA Waiver and Dual 510(k) CLIA Waiver Submissions to FDA

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.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email customercare@complianceonline.com call +1-888-717-2436 (Toll Free).

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