Medical Device US FDA Pre-Market Submissions

US FDA 101 - Fundamentals of Pre-market Submissions to CDRH

About

What is the 510(k) and how is it different from a Pre-market application (PMA)?
What are 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 and what do they mean?
How and when is a Q-Sub useful?

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

This workshop takes a deep dive into the fundamentals of the US FDA regulatory framework and identify the difference in approach to EU requirements.

We will use interactive case studies to better understand the practical applications of the submission pathway and process and discuss the basic expectations of the 510(k) and Pre-submission packets - what does and doesn’t belong in a Pre-Submission? What are the manufacturer and FDA expectations in a Pre-submission meeting?

Module 1

Overview of US FDA history and organization
Overview of submission pathways
Case Study (group-work): Submission Types

Module 2

510(k) sections – eSTAR platform and eCopy
Pre-Submission fundamentals
Case Study (group-work): Pre-submission Questions

EU Regulatory professionals who are unfamiliar with US FDA requirements and what are 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

Lecturers

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.

Useful information
Registration Fee

Online Training – 2 modules

MODULE 1 | 10 October 2024 from 1:30 pm to 5:00 pm CEST
MODULE 2 | 11 October 2024 from 1:30 pm to 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: € 795,00* (until 19 September 2024)

Ordinary: € 990,00*

Freelance – Individual – Academy – Public Administration**: € 515,00*

* for Italian companies: +22% VAT

**Early Bird discount not applicable to Freelance – Individual – 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.

Ilaria Butta
Events & Training Manager

Printable Version

At the end of the training, you will be able to

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