Medical Device Change Control and FDA Submissions

This course is intended to provide an overview of 2 new FDA draft guidance documents that clarify when medical device and software manufacturers must file a 510(k) (premarket notification) for changes to an existing device and/or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To learn how to interpret and apply the two draft guidance set forth by FDA on submission of a 510(k) for changes to medical devices and/or software used in conjunction with medical devices
The 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
The course will provide useful information to medical device and software developers who manage changes to these devices and/or software
The audience will learn what device changes and/or software changes will likely require the submission of a 510(k) and what ones will not
We will discuss when and how the draft guidance documents should be applied in industry
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.
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.

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