This on-demand session gives a basic understanding of the U.S. regulations for medical and in vitro diagnostic devices. The regulatory path to the U.S. market and essential items related to the FDA and the U.S. Food and Drug Administration are reviewed.
All health tech developers and other stakeholders interested in how to enter the US market and which are the main issues to be considered when submitting a sales approval application to the FDA.
After this session, you
Know the typical routes to the U.S. market and what is required in terms of contents and quality of the submission package.
Understand the fundamental differences between the European and U.S. regulations for medical device manufacturers.
Have a basic understanding of approaches by the FDA reviewers and “the U.S. way of thinking.”
Notice
Following the Regulatory Essentials sessions 1-5 before this on-demand session is recommended.
Read the billing and cancellation policy for online trainings here.
Participation in the training can be cancelled two weeks (14 days) before the event free of charge. For cancellations made after this, we will charge 50% of the participation fee, except for cancellations made one week before the event, we will charge a 100% participation fee.
Cancellations are always made in writing to: koulutus@labquality.fi. The participating organization may, if it wishes, change the participant free of charge by notifying it in writing before the event to:
koulutus@labquality.fi. The participation fee will be invoiced immediately after the event. The training session will be confirmed to the participant by e-mail about a week before the event. Labquality reserves the right to cancel the training session due to a small number of participants.
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