Dive Brief:

• FDA issued final guidance to explain its procedures and criteria, including the types of information needed, for assessing whether a device manufacturer’s De Novo classification request should be accepted for substantive review. The document, dated Sept. 9, finalizes draft guidance issued on Oct. 30, 2017.
• The purpose of the acceptance review is to assess whether a De Novo request is administratively complete and includes all the information necessary for FDA to conduct a substantive review. The acceptance review should be completed within 15 calendar days of FDA receiving the De Novo request, according to the agency.
• The guidance document includes both an "acceptance checklist" and a "recommended content checklist."

FDA Insight:

A De Novo marketing authorization establishes a new classification category for low- to moderate-risk, first-of-a-kind products. FDA wants to steer device makers away from the old 510(k) predicates in favor of the De Novo premarket approval pathway. By encouraging more manufacturers to use the De Novo pathway, the agency can establish more new predicate devices as it seeks to phase out 510(k) predicates older than 10 years.

In its final guidance on acceptance reviews, FDA said its staff should answer a set of seven questions intended as an initial screening of the De Novo request within 15 calendar days of receiving the request. The questions address whether the product is a device or combination product with a device constituent part, whether the request has been made with the appropriate center, how to handle a request for designation, how to handle a combination product that contains certain drugs, whether there is a pending premarket notification for the same device, and whether the requester is subject to the application integrity policy.

The question on combination products that contain a drug with "the same active moiety as an approved drug with exclusivity" is an addition to the final guidance that wasn't included in the draft version. Three more sections addressing combination products have been added to the checklist for acceptance review. FDA also added a paragraph explaining it doesn't expect De Novo requests for the same device type from different requesters to frequently be under review at the same time.

In December, FDA proposed a rule seeking to clarify minimum content criteria for classifying devices through the De Novo pathway. The proposed regulation provides descriptions for the format and content of De Novo requests as well as processes and criteria for accepting, granting, declining, and withdrawing a request.

So far this year, FDA has granted 15 De Novo clearances, a slower pace compared to the 26 it awarded by Aug. 30 last year. This year's approvals through the pathway include Tandem Diabetes' interoperable insulin pump, a wearable wireless neuromodulation patch for acute treatment of migraine and a temporary coil embolization assist device to help treat aneurysms.