CPC Provides Comments on FDA’s Proposed Rule for the Medical Device De Novo Classification Process

On March 7, 2019, CPC provided feedback on the proposed rule for the Medical Device De Novo Classification Process. As part of this feedback, CPC notes that it concurs with and supports the applicability of the De Novo process to the device constituent of what are commonly referred to as “cross-labeled” combination products, and asks FDA to consider including “co-packaged” combination products (per 21 C.F.R. § 3.2(e)(2)) that are designated as device mode of action in the De Novo process, as such products would also benefit from the application of least burdensome provisions and potentially classification as Class II devices.