Medical Device Change Control and FDA Submissions

Pre Recorded

  • 90 minutes

This course is intended to provide an overview of 2 new FDA draft guidance documents that clarify when medical device and software manufacturers must file a 510(k) (premarket notification) for changes to an existing device and/or software integrated with a device. The FDA notes that while neither of these drafts specifically includes combination products, the general concepts may be helpful in determining whether changes to device constituent parts of combination products need a 510(k).

The critical decision is whether a proposed change to a legally marketed medical device subject to premarket notification requirements is significant enough to require FDA review. This includes any major change or modification to the intended use of the device that could have an impact on patient safety and effectiveness.

In this webinar expert speaker Carolyn Troiano will aid manufacturers of medical devices who intend to modify a 510(k)-cleared device or a preamendments device subject to 510(k) (i.e., “existing devices”) during the process of deciding whether the modification exceeds the regulatory for submission and clearance of a new 510(k).

Session Highlights:

  • To learn how to interpret and apply the two draft guidance set forth by FDA on submission of a 510(k) for changes to medical devices and/or software used in conjunction with medical devices

  • What device changes and/or software changes will likely require the submission of a 510(k) and what ones will not

  • Guiding Principles for filing 510(k)

  • How to make decision of submissions of 510 (k) (with flowcharts)

  • Cases of material changes

  • Requirements of 510(k)

  • Guidance effects on In-Vitro Devices

  • Three Categories referred in draft

  • Custom Device Exemption:- Requirements & What qualifies

Why You Should Attend:

This webinar is intended for those who are involved in manufacturing changes to medical devices and related software, and those conducting supporting clinical trials and other types of testing to demonstrate substantial equivalence in terms of a device’s safety and effectiveness. Understand the impact this guidance will have on the development, management and use of medical devices and software used in conjunction with medical devices that have been modified.

You should attend this webinar if you are responsible for planning, executing or managing the modification of any medical device governed by FDA regulations, or if you are providing testing support.

Who Should Attend:

Manufacturing, Testing, Packaging and Distribution companies in the following industries that are regulated by FDA are required to follow GDPs:

  • Pharmaceutical Medical Device

  • Biologicals

  • Tobacco

  • Personnel in the following roles will benefit:

  • QC/QA Managers and Analysts

  • Clinical Data Managers and Scientists

  • Quality Managers, Chemists and Microbiologists

  • Compliance Managers and Auditors

  • Computer System Validation Specialists

  • Regulatory Affairs Personnel

  • Consultants in the Life Sciences and Tobacco Industries

Ask your question directly from our expert during the Q&A session following the live event.

Carolyn  Troiano

Carolyn Troiano

Carolyn Troiano has more than 35 years of experience in computer system validation in the pharmaceutical, medical device, tobacco and other FDA-regulated industries. She is currently an independent consultant, advising companies on FDA compliance, computer system validation and large-scale IT system implementation projects. Carolyn participated in the Industry/FDA partnership that developed 21 CFR Part 11, the FDA’s guidance on electronic records and electronic signatures (ER/ES).

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