The FDA Group's CEO, Nick Capman, sits down with Regulatory Attorney Christine P. Bump to discuss the current regulatory landscape for medical devices and the importance of developing a thoughtful regulatory strategy.
Discussion points include:
» The three classifications of medical devices and the various regulatory submission types — each with different risk levels, required data, costs, and approval timelines.
» The costs associated with FDA approval.
» Why it's important to craft a regulatory strategy early, even at the product concept stage, to determine device functionality and anticipate FDA requirements.
» The challenges that the rapidly evolving nature of software, algorithms, and AI present for the FDA's traditional device paradigm.
» The benefits of pre-submission meetings with the FDA, which provide valuable feedback and insights to streamline the submission process.
» The differences between regulatory attorneys and consultants.
» The common pitfalls for companies navigating the FDA approval process, such as insufficient budgeting and lack in-house expertise.
» The importance of planning well in advance and adjusting operational goals to align with regulatory requirements.
» The importance of understanding product claims to avoid regulatory complications.
Christine is a regulatory attorney with more than 15 years of experience developing and implementing FDA strategies for cutting-edge technologies. As the founder of Penn Avenue Law & Policy, she focuses on devices, software as a medical device, digital health, diagnostics, wellness, genetics and genomics, and advertising and promotion. She advises CEOs, scientists, and teams of all levels regarding regulatory pathways, clinical investigations, premarket submissions, pre- and postmarket compliance, and promotional issues. She counsels a variety of clients, including start-ups, national and multi-national corporations, venture capital groups, and portfolio companies on navigating the FDA process. https://www.pennavenuelaw.com/
Who is The FDA Group? The FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus in Quality Assurance, Regulatory Affairs, and Clinical Operations. https://www.thefdagroup.com/