FDA’s Final Guidance on “Least Burdensome” Principles for Medical Devices
Products Liability and Mass Tort co-chair Michael C. Zogby and associate Abigail Luhn recently posted an article, “FDA’s Final Guidance on ‘Least Burdensome’ Principles for Medical Devices.” The “least burdensome” principles of the 2019 Guidance direct manufacturers to provide “the minimum amount of information necessary to adequately address a relevant regulatory question or issue through the most effective manner at the right time.” This guidance broadens the scope of impacted device submissions. The least burdensome concept applies “to all products that meet the statutory definition of a device, including device constituent parts of combination products.”
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