Have you heard about FDA’s new guidance documents?
Join us for an overview of a selection of new FDA guidance documents.
We will focus on recent guidances that are related to pathways to the US market.
Note: This seminar will be held in French.
Seminar Contents
Guidance Title | Issued Date |
Breakthrough Devices Program |
2018-12-18 |
The Special 510(k) Program |
2019-09-13 |
Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program |
2019-05-07 |
Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions |
2019-08-30 |
FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act |
2019-12-16 |
For multiple attendees, we can also conduct on-site seminars.
Please contact seminar@kenblockconsulting.com for further information.
Date: |
TBD |
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Time: |
14:00 – 17:00 |
Fees: | 350 € Regular Price 300 € Early Bird |
Please register here if you wish to receive information on future seminars.