ComplianceOnline

U. S. FDA Medical Device Approval Process

Instructor: John E Lincoln
Product ID: 700863
  • Duration: 60 Min

recorded version

$249.00
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: Apr-2008

Training CD / USB Drive

$500.00
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(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days

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Read Frequently Asked Questions

Where ever justified, the 510(k) submission process is the preferred method for obtaining marketing clearance in the U.S.

Description

In order to market a medical device in the U.S., manufacturers, foreign or domestic, must go through one of two evaluation processes by the U. S. FDA: Class 1 - exempt; Class II - Premarket Notification, 510(k); or Class III - Premarket Approval (PMA), a much more involved, costly and time-consuming process.

Where ever justified, the 510(k) submission process is the preferred method for obtaining marketing clearance in the U.S. How are such decisions arrived at? Differences from the EU MDD Annex IX schema. What is involved? Sequence of events? FDA expectations. What’s included? Desired format? Expected time frames and the post-submission review process "give-and-take".

Areas Covered in the seminar:

  • U.S. FDA Class I, II, and III products.
  • Similarities / differences with the EU MDD Annex IX Rules.
  • The importance of the “Intended Use” statement.
  • How to locate and choose predicate devices.
  • Exempt, 510(k), and PMA device categories.
  • Using the Code of Federal Regulations.
  • Risk Analysis; Software considerations / reporting.
  • Design Control, Change Control, and DHF files.
  • Cumulative changes; sale to product / IP to another company; follow-up actions.

Who will benefit:

  • Senior Management
  • New product project leaders / team members
  • Regulatory affairs
  • Quality systems personnel
  • R&D and engineering staff
  • All charged with new product development, risk analysis / management, regulatory submissions, and validations

Instructor Profile

John E. Lincoln,Consultant, has successfully developed and implemented and trained to device, pharma, medical gases, and dietary supplements CGMP-compliant systems. He has conducted compliance audits in all these areas. His systems have passed FDA audit or submission scrutiny, and have been described in peer-reviewed technical articles, and workshops, world wide. John has also managed pilot production, regulatory affairs, product development projects; with over 25 years of experience, in FDA-regulated industry - working with start-ups to Fortune 100 companies, including Abbott Laboratories, Hospira, Tyco / Mallinckrodt. John serves on the Reader and Editorial Review Boards of MDDI Magazine and the Journal of cGMP Compliance, and Intermountain Biomedical Association); he publishes a newsletter. He is a graduate of UCLA.

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Upcoming In-person Seminars by EX-FDA OFFICIALS
Medical Device Summit 2018

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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