Decision Criteria: New FDA Guidance Impacting the Requirement for 510(K) Clearance of Modified Devices
Thursday January 18, 2018 – 12:00PM EST to 1:00PM EST
This course is forecasted for a 45 minute presentation followed by 10 to 15 minutes of Q&A.
In October 2017, the FDA issued two final guidance documents which outline when a change to an existing device necessitates a 510(k) filing, formally titled “Deciding When to Submit a 510(k) for a Change to an Existing Device” and “Deciding When to Submit a 510(k) for a Software Change to an Existing Device”. These guidances were originally published as draft recommendations in August 2016, and largely remain consistent with further explanation and details on guiding principles. Determining when a modification to a legally marketed medical device triggers the need for a 510(k) application is a significant and ongoing challenge for regulatory professionals, and the new guidance will provide manufacturers with a greater understanding of the FDA’s expectations in the current regulatory environment.
- Important changes in device and software modification guidances
- Common software changes that might require a 510(k) filing
- Case study analysis on instances requiring/not requiring a new 510(k)
Participants that will find this webinar most beneficial will be those involved in medical device companies. Job titles of attendees that will be most applicable for this session will be:
- Regulatory Affairs
- Regulatory Submissions
- Quality Assurance
Kelliann Payne’s science education and background in the medical device industry allow her to quickly understand emerging medical device technology and informs her current focus on related legal and business issues. Her experience includes the development, regulation, advertising, and litigation of medical devices.
Kelliann drafts premarket submissions for diagnostic and therapeutic medical devices, evaluates and formulates applicable regulatory strategies, and reviews the accuracy of marketing claims. She helps companies in their preclinical and clinical programs and leads due diligence reviews for investments and acquisitions.
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