webinarbrite


Breakthrough Devices Program Updated Final Guidance

John E. Lincoln
Date & Time: All Days
Duration: 90 Minutes
Category: Pharmaceutical
Type: Recorded Webinar

Description

Join us for an informative webinar on the updated final guidance for the Breakthrough Devices Program. The FDA has issued critical updates to the program, addressing various aspects, including health equity, innovation, pain, addiction management, and transparency in device designation. Learn about these changes and gain valuable insights from industry experts.

Key Highlights:

  • What is the Breakthrough Devices Program?
  • Benefits of the program.
  • Clarifications on eligible devices, including those promoting health equity.
  • When and how to request a Breakthrough Device designation.
  • What to include in your request.
  • What to expect from the FDA if your device is designated as a Breakthrough Device?
  • She related expedited programs for specific devices.
  • FDA's disclosure process for Breakthrough Device status.
  • How many devices have received Breakthrough Device designation?
  • How many have received marketing authorization?
  • Available guidances related to the Breakthrough Devices Program.

Why Attend?

  • Introduction to the Breakthrough Devices Program
  • Eligibility and Designation
  • FDA Support and Disclosures
  • Breakthrough Device Statistics

Who Should Attend?

  • Medical device developers
  • Regulatory affairs professionals
  • Healthcare innovators
  • Industry stakeholders
  • Anyone interested in the latest developments in medical device regulation

Price Details

Speaker Profile : John E. Lincoln

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 of which are as an independent 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 QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files, CAPA systems and analysis.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. He writes a recurring column for the Journal of Validation Technology. John is a graduate of UCLA.