FDA suggests improvements to De Novo pathway for novel medical devices
USA: The Food & Drug Administration (FDA) has published the De Novo Classification Proposed Rule, which proposes improvements to the De Novo pathway for novel medical devices to advance safe, effective and innovative treatments for patients.
The De Novo pathway is used for the review of novel, moderate to low 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 in determination of substantial equivalence.
If the proposed rule is finalized, it would establish procedures and criteria for the De Novo classification process and become part of the Medical Device Classification Procedures (21 CFR Part 860). The proposal allows sponsors to submit a De Novo classification request with or without first receiving a NSE (Not Substantially Equivalent) determination on pre-market notification (510(k)) submission. The FDA would still have authority to refuse a De Novo request that is ineligible or is incomplete on its face in the proposed rule.
Dr Om Singh, Senior Scientific Consultant, TSG Consulting says: “The proposed rule provides a pathway for certain new types of device to obtain marketing authorization as a class I or class II device, rather than remaining automatically designated as a class III device, which would otherwise require pre-market approval (PMA). If finalized, the proposed rule will help bring greater efficiency in the De Novo classification process for both industry and the FDA.”