FDA Boot Camp Devices Edition
The clearance and approval process…pre-approval concerns…product labeling… clinical trials and IDEs…MDRs… QSRs… post-market controls…recalls and withdrawals…enforcement – all are critical aspects in the commercialization process for medical devices, which are governed by FDA law and regulation.
Recent court cases, and high-profile trials concerning FDA-regulated products have made it clear that it is essential for attorneys who do not have regulatory practices — but who do deal with FDA-regulated medical devices — to have a familiarity with these concepts. The changing business dynamics of the life sciences industry have also made it critical for business executives, policy analysts and securities experts who work in this field to have a clear understanding of the dynamics of the FDA.
Many products liability lawyers, patent counsel, business and investment experts, medical and regulatory affairs professionals, and those involved in pricing and reimbursement — despite their tenure in working with FDA-regulated devices — are not well-versed in the essentials of the approval process and the regulatory hurdles of the post-approval period. Whether you are a products liability or patent litigator, in-house counsel, in-house business development or federal affairs professional, FDA Boot Camp – Devices Edition will provide you the insights you need.
Learn about the FDA approval process and the ins and outs of post-approval challenges
ACI’s second annual FDA Boot Camp – Devices Edition has been designed to give products or patent litigators, as well as patent prosecutors, industry in-house counsel, and life sciences investment and securities experts, a strong working knowledge of core FDA competencies.
A distinguished faculty of top FDA regulatory device experts — a “Who’s Who of the FDA Bar” — will share their knowledge and give you critical insights on:
- The organization, jurisdiction, functions, and operations of the FDA
- An overview of medical device regulations
- The classification of devices and the concept of “risk-based” classification
- Clinical trials and IDEs
- The 510(k) clearance process – what you need to know now and what to expect in the future
- The premarket approval process (PMAs) and drug labeling and promotion
- General post-market controls and MDRs
- QSRs vs. cGMPs and ISO
- Mitigating the impact of enforcement actions
- Recalls, product withdrawals, and FDA oversight authority
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