Dive Brief:

• In comments filed in response to FDA's proposed rule on the De Novo classification process for medical devices, AdvaMed said it is concerned the framework imposes some requirements that replicate the premarket approval (PMA) application review.
• Such requirements conflict with the intent of the De Novo pathway to limit unnecessary expenditure of FDA and industry resources, the medical device lobby said.
• AdvaMed advised FDA to conduct quality system and clinical data inspections only after making a De Novo decision for a device. The group also took issue with a requirement for submission of study data, suggesting that FDA's description of the information it seeks is unclear.

Dive Insight:

FDA has been trying to encourage manufacturers to utilize the De Novo pathway for new medical devices and lessen reliance on older 510(k) predicate devices. If more manufacturers use the De Novo pathway, the agency can establish more new predicate devices while evaluating its idea of phasing out older 510(k) predicates.

The agency, in proposing the new De Novo classification rule, said it aims to make the pathway more efficient and transparent by clarifying submission requirements and review processes. If finalized following the comment period, the rule would add a new section to the Medical Device Code of Procedures.

AdvaMed, in its comments, commended the agency's goal of improving clarity and predictability in the review process. But it found fault with a provision of the proposed rule that authorizes FDA to inspect facilities before making a De Novo decision. "We believe that this approach is misaligned with applicable statutory and regulatory provisions and that it will disrupt timely review of De Novo submissions," the trade group said.

FDA should conduct facility inspections after making its De Novo decision, AdvaMed said, noting that the process puts a device into Class I or II, for which premarket review does not include quality system inspection.

Another requirement under the proposed rule, that device makers submit studies, data and other information that is "known or reasonably known," creates an unclear standard and raises the risk of inconsistent submissions, the group argued. It advised FDA to change the criteria to "known by or reasonably available to the requester."

Echoing some of AdvaMed's concerns, medical device maker Cook Group said in its own comments that many of the regulatory submission requirements for the De Novo application are nearly identical to those for PMA approval.

"Requirements such as facility inspections, labeling approval, comparisons to existing procedures and products, and detailed analyses of benefit and risk add needless burden to what is essentially a classification process. This additional burden may effectively nullify a significant advantage of going through the De Novo pathway and result in many developers abandoning development of novel lower-risk products due to artificially high regulatory barriers," Cook warned.

The American College of Cardiology urged FDA to retain patient safety as its top priority as it modifies the De Novo process and continues to refine oversight of medical device safety.

"It is important for the FDA to balance the reduction of regulatory burdens that inflate the cost and time associated with new therapy development with the need for regulatory decisions that protect patient interests and public health through rigorous scientific merit," the medical group said.