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

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.

Next Date

Date: 

TBD
Time: 

14:00 – 17:00
Fees: 350 € Regular Price
300 € Early Bird

 

 

 

 

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