Introduzione
Do you want to bring a medical device to the US market, but feel you are entering a jungle of regulatory processes and requirements that are difficult to navigate and understand?
These are questions that sound all too familiar:
- What is the 510(k) procedure and how is it different from a Pre-Market Application (PMA)?
- What is the Code of Federal Regulations (CFRs) and how does it affect the general and special requirements of specific classes of medical devices?
- What are the 3-letter product codes assigned to devices and what do they mean?
- What is a Q-Sub? 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 identifies the difference in approach to EU requirements.
We will use interactive case studies to better understand the practical applications of the different possible submission pathways and processes.
We will discuss the basic expectations of the 510(k) procedure and pre-submission packets: what does and doesn’t belong in a pre-submission and what the manufacturer and FDA expectations are 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 is expected in FDA submissions.
Participant experience
No US FDA experience required.
Familiarity with Design History File (DHF) documentation is a plus.
Lecture series with integrated group-work and case-studies
Docente/i
Cherry Malonzo Marty
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 1st 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.
Online Training – 2 modules
MODULE 1 | 07 April 2025 from 1:30 pm to 5:00 pm CEST
MODULE 2 | 08 April 2025 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: € 790,00* (until 17 March 2025)
Ordinary: € 980,00*
Freelance – Individual – Academy – Public Administration: € 565,00*
* for Italian companies: +22% VAT
The fee includes: tuitions, organizational office assistance, teaching materials and attendance certificate that will be sent after the training via e-mail.
Registrati
Ilaria Butta
Events & Training Manager
Cosa saprai fare dopo il corso
Online interactive training on Zoom platform.
LS Academy will provide the access link to the virtual platform a few days before the training.