Device Changes and the 510(k) – Hardware and Software

Duration 90 Mins
Level Intermediate
Webinar ID IQW20B0245

  • The old K-97-1
  • Product changes and filing a new 510(k) – who’s responsible
  • Documenting the process / rationale
  • Resolving a “wrong decision”
  • The Two U.S. FDA Guidance Documents on 510(k) Device Modifications:  Deciding When to Submit a 510(k) for a Change to an Existing Device – 1) the Device, and 2) the Device Software / Firmware -- key areas
  • Tracking and evaluating changes – 1) A major single change, or 2) a collection of minor changes, and 3) the “tipping point”

Overview of the webinar

This webinar will evaluate two recently published U.S. FDA Guidance Documents on device changes: 1) “Deciding When to Submit a 510(k) for a Change to an Existing Device Final Guidance for Industry and FDA Staff”; and 2) “Deciding When to Submit a 510(k) for a Software Change to an Existing Device Final Guidance for Industry and FDA Staff”; both published October 25, 2017. Such changes pertain to change to a medical device that a company currently has in commercial distribution or is reintroducing into commercial distribution.Such a device is about to be significantly changed or modified in design, components, method of manufacture, or intended use.Significant changes or modifications that require a premarket notification are: 1) A change or modification in the device that could significantly affect the safety or effectiveness of the device, e.g., a significant change or modification in design, material, chemical composition, energy source, or manufacturing process; 2) A major change or modification in the intended use of the device.The guidances’ also address when a series of less significant changes, evaluated collectively, trigger such premarket notification ( a new 510(k)).Methods to control, track, evaluate and document the change evaluation process. The importance of design control / change control in this process.

Who should attend?

  • Senior management
  • Middle management / staff
  • Operations / manufacturing
  • R&D
  • Engineering
  • Marketing and Sales
  • QA / RA

Why should you attend?

The Device CGMPs require (21 CFR 820.30(i) Design changes) that each manufacturer “shall establish and maintain procedures for the identification, documentation, validation or where appropriate verification, review, and approval of design changes before their implementation.” How can this be done?  Systems / documentation  required? What device and/or software changes trigger the requirement to file a new 510(k)? Analysis of the two U.S. FDA Guidance Documents on device and doftware dhanges to determine regulatory expectations. What single changes trigger such action? When a collective series of smaller changes trigger such action? 

Faculty - Mr.John E. Lincoln

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 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 including 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 ptublished 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.


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