Developing an FDA Regulatory Strategy (Part 2)

In this two-part webinar series, R&Q presents the definitive resource for bringing your medical device to market in the United States. Part 1 of the series was presented in January 2020 and focused on Class I and Class II devices — it's available on demand here.

Part 2 will address Class III devices.

This webinar is designed to help you create a comprehensive regulatory strategy that enables you to successfully enter the US market.

This webinar is not is a rehash of the regulations (we'll provide references, however).

We'll begin by looking at everything that needs to be included in a thorough regulatory strategy. While viewing the big picture can be daunting at first, it's a critical step to understanding the strategic process and formulating an efficient, cost-effective plan... that works.

Webinar breakdown:

• PMA Overview (e.g. requirements, cost, timing)
• How to determine if a PMA is necessary vs De Novo vs HDE
• Evaluating alternative sources for clinical evidence
• Discussion of PMA programs designed to help expedite patient access
• Update on CDRH structure and how it affects the PMA review process
  

Considering the challenges related to EU MDR, this webinar series may be especially helpful to European companies considering the US as a new market. 

Presenters

Kevin Go, MBA, CQA – Senior Engineer (former FDA)
Regulatory & Quality Solutions (R&Q)

Kevin has experience working in both the public and private sector, as well as various-sized organizations ranging from small start-ups to multi-national corporations. He recently joined R&Q Solutions, after working at FDA for over 5 years. In his time at FDA, he served as a Lead Reviewer in the Division of Orthopedic Devices, where he reviewed numerous pre- and post-market submissions. Additionally, he also served as an Advisor to the CDRH Innovation group and Payor Communication Task Force, where he provided early regulatory and reimbursement assistance to small businesses. Kevin has Bachelor of Science in Biomedical Engineering, a Masters in Business Administration, and CQA certification.

Bryan Pinder, MBA, CQA – Project Engineer (former FDA)
Regulatory & Quality Solutions (R&Q)

Bryan Pinder has almost 14 years of experience in the medical device industry. After graduating with bachelors and masters degrees in biomedical engineering, Bryan started his career with FDA. He spent 9 years at CDRH as a lead reviewer of orthopedic devices. Bryan specialized in small joint and fracture fixation reviews and also advised guidance document development. Prior to coming to R&Q, Bryan spent 4 years as a Risk Manager and Regulatory Engineer for a manufacturer of electro-mechanical and software-only medical devices.