Medical Device US FDA Pre-Market Submissions

Fundamentals of Medical Device US FDA Pre-Market Submissions

Introduzione

What is the 510(k) and how is it different from a Pre-market application (PMA)?
What is the Code of Federal Regulations (CFRs) and how do they affect the general and special requirements of specific medical devices?
What are the 3-letter product codes assigned to devices?
How and when is a Q-Sub useful and is it the same as a Pre-Submission?

Let’s start with untangling nomenclature and understanding how the United States Food and Drug Administration (US FDA) regulates medical devices.

This workshop tackles fundamentals of the US FDA regulatory framework and we look into the basic expectations of the 510(k) and Pre-submission packets - what does and doesn’t belong in a Pre-Submission? Are there similarities between the US FDA submission documents and the EU submission requirements?

1st half-day:

Overview of US FDA history and organization
Overview of submission pathways
Case Study (group-work): submission types & database

2nd half-day:

510(k) sections and fundamentals
Pre-Submission purpose and expectations
Case Study (group-work): pre-submission questions

EU Regulatory professionals who are unfamiliar with US FDA requirements and what is expected in FDA submissions.

Participant experience
No US FDA experience required
Familiarity with DHF documentation is a plus

Lecture series with integrated group-work and case-studies

Docente/i

Info

Cherry Malonzo Marty

MD, MSc BME – M3W (Malonzo Marty Medical Writing)

Cherry Malonzo Marty is an MD and Biomedical Engineer by training. She has over 10 years of experience working in various functions in education, clinical settings, research, and regulatory affairs. She has co-authored the book chapter “Evolving Global Regulatory Landscape” in the 1^st edition of The Combination Products Handbook published in 2023. Since 2019, she has been working as a freelance regulatory writer and consultant for medical device and combination product submissions in the US and EU. Since 2021, she is the module leader for International Regulatory Affairs at the sitem Center for Translational Medicine and Biomedical Entrepreneurship in Bern, Switzerland. Apart from her freelancing projects, she currently works part-time as the Regulatory and Quality writer for a spin-off of ETH, Zürich.

Durata e Informazioni utili
Quote Iscrizione

Online Training – 2 modules

05 October 2023 1:30 pm – 5:00 pm CEST
06 October 2023 1:30 pm – 5:00 pm CEST

After the registration, you will receive all details about the connection.

The course will proceed with a minimum number of participants. Should this number not be reached the registered participants will be notified one week prior to the commencement of the course.

Early Bird: € 770,00* (until 14 September 2023)

Ordinary: € 960,00*

Freelance – Academy – Public Administration**: € 500,00*

* for Italian companies: +22% VAT

**Early Bird discount not applicable to Freelance – Academy – Public Administration fee

The fee includes: tuitions, organizational office assistance, teaching materials and attendance certificate that will be sent after the training via e-mail.

Versione Stampabile

Cosa saprai fare dopo il corso

Identify the different types of US FDA pre-market submission pathways

Understand the different US FDA search databases

Be familiar with the sections of a 510(k)

Understand the FDA expectations in a Pre-Submission

Online interactive training on Zoom platform.

LS Academy will provide the access link to the virtual platform a few days before the training.

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Medical Device US FDA Pre-Market Submissions