The eSTAR Submission Program for 510(k)s, IDEs, De Novos, PMAs, and Q-Submissions

The regulation and control of new or substantially changed medical devices for sale in the US is based on the 510(k), PMA or DeNovo submission process; 510(k)s now can only be submitted to the FDA under the eSTAR (electronic Submission Template And Resource) Portal. Other submissions will be phased in using new guidance templates as they become available.

Live Online Training
May 28, Tuesday 10:00 AM PT | 01:00 PM ET (90 Min)

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Recorded Version Only

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rec Recorded Link and Ref. material will be available in My Account Section 48 hrs after completion of Live training

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Downloadable link along with the materials will be emailed within 2 business days after completion of Live training
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This webinar will discuss current US Federal law on the 510(k), IDE, DeNovo, and PMA and associated requiements for getting a new or substantially changed medical device through the US FDA review process and to market in the USA. US law and the FDA require that a device be the subject of an approved marketing application before it is transported or distributed across state lines. While ultimately all submissions will be by electronic means under the FDA's eSTAR submission template, currently only 510(k) have a final submission eSTART submission guidance, required to be used as of October 1, 2023. Other templates will be released in the future. Two Guidance documents, 1) a "Parent" / covering guidance discusses the entire eSTAR program for all types of submissions, and 2) the first, now finalized and operative as of October 2023, specific Guidance template, for 510(k)s, under the eSTAR program.

Why Should You Attend:

For decades, the regulation and control of new or substantially changed medical devices for sale in the United States (no matter where manufactured has been based on a paper and e-copy 510(k), PMA or DeNovo submission and FDA review process. That has all changedd as of October 2023. Now a 510(k) clearance for Class II devices required prior to comercialization, can only be submitted for review through the Agency's new eSTAR portal. IDEs, DeNovos, or of a higher risk requiring clinicals, the PMA, will be required to be submitted electronically through eSTAR at later dates as new guidance templates for each are published by the Agency. The 510(k) process has had some recient modification to allow for newer technology (Breakthrough) or increased safety (STeP). And new Cybersecurity, Machine Learning and Artificial Intelligence features add additional complexity to the process.

Areas Covered in the Webinar:
  • The new eSTAR Device Submissions and the US FDA
  • The 510(k) process
  • The "Parent" eSTAR Guidance
  • The first specific Guidance, the 510(k) eSTAR Submission Template
  • Cybersecurity Submission Requirements
  • New 510(k) Mod program and Q-Sub
  • Machine Learning and Artificial Intelligence Issues - FDA "Principles"
  • Post-market requirements
Who Will Benefit:
  • Senior management in Devices, Combination Products
  • QA / RA
  • Medical Device product development teams
  • R&D
  • Engineering
  • Production
  • Operations
  • Marketing
  • Consultants; others tasked with device product development, manufacturing, process / product / data analysis, regulatory submission responsibilities
Instructor Profile:
John E Lincoln 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 36 years’ experience in U.S. FDA-regulated industries, 22 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'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 CAPA, 510(k)s, risk analysis / management, FDA / GMP audits, validation, root cause analysis, and others. John is a graduate of UCLA.

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. FDATrainingAlert 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 call +1-888-771-6965 (Toll Free).

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