FDA Hot Topics

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


The Special 510(k) Program


Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program


Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions


FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act


For multiple attendees, we can also conduct on-site seminars.
Please contact seminar@kenblockconsulting.com for further information.

Next Date




14:00 – 17:00

Fees: 350 € Regular Price
300 € Early Bird





Please register here if you wish to receive information on future seminars.


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