Bonnie Odom and Megan Robertson, attorneys in the Health Care & Life Sciences practice, co-authored the chapter “In Vitro Diagnostic (IVD) Devices,” in the Medical Devices Law and Regulation Answer Book, published by the Practising Law Institute (PLI).
Following is a summary:
- Overview of the legal framework of FDA regulation of medical devices
- Pre-market considerations, including clinical trials, IDEs, 510(k) and PMA submissions, 3D printed devices, devices used with regenerative therapies, combination products, restricted devices, custom devices, and radiological products
- Special FDA COVID-19 policies, emergency use authorizations, cybersecurity, laboratory-developed tests, new technologies, medical device licensing, and pandemics beyond COVID-19
- Manufacturing compliance, FDA inspections, and in vitro diagnostics
- The Quality System Regulation, post-market issues, including device promotion, adverse event reporting, and international considerations
- Interacting with FDA and government enforcement and device commercialization and related issues, including industry-supported scientific activities, intellectual property, licensing, reimbursement, privacy, product liability, preemption, criminal enforcement, and oversight by other federal agencies