FDA Wants to Change the De Novo Pathway

Last week, FDA revealed plans to modernize the 510(k) clearance pathway, which was adopted in 1976 and now accounts for the majority of medical devices the agency reviews. This week, the agency has turned its attention to the de novo pathway for medical devices. The de novo pathway is used for the review of novel, low to moderate risk devices for which general controls, or general and special controls, provide a reasonable assurance of safety and effectiveness, but for which there is no existing predicate to use to determine substantial equivalence. According to FDA Commissioner Scott Gottlieb, MD, the de novo pathway for novel medical devices allows the agency to review new technologies so that patients have timely access to safe and effective devices to improve their health. As FDA works to modernize the 510(k) pathway, Gottlieb said the de novo pathway provides a vehicle for establishing new predicates that can reflect modern standards for performance and safety and can serve as the basis for future clearances. FDA published the De Novo Classification Proposed Rule would, if finalized, facilitate appropriate classification of new types of medical devices, according to the agency. For example, the proposed regulations and requirements will provide structure, clarity, and transparency on the de novo classification process, including requirements related to the format and content of de novo re...
Source: MDDI - Category: Medical Devices Authors: Tags: Regulatory and Compliance Business Source Type: news