De Novo Rule Clarifies Device Inspections

A new FDA final rule on the medical device de novo marketing pathway has modified earlier language contained in the proposed rule to now permit manufacturing inspections in limited scenarios. The rule establishes procedures and criteria for submitting a de novo request, which can occur after a device sponsor receives a 510(k) “not substantially equivalent determination,” or if there is no legally marketed device upon which to base a substantial equivalence determination.

Several commenters on the earlier proposed rule said that FDA requiring inspections before a de novo is granted/denied is “unduly burdensome” or statutorily authorized to assess implementation of the Quality System Regulation (QSR). In rejecting this premise, FDA’s final rule now clarifies the limited scenarios when an inspection may occur.

Under the final rule, an inspection would occur under two circumstances: 1. To verify clinical and nonclinical data, and 2. To verify Quality System Regulation and GMP requirementss for certain devices with critical and/or novel manufacturing processes.

According to the agency, an inspection prior to deciding on the de novo submission may be necessary to help FDA determine whether the clinical or nonclinical data were collected in a manner that ensures the data accurately represents a device’s risks and benefits. “FDA has been conducting such inspections when data integrity and quality concerns arise during its review of a de novo request, and information from these inspections has been critically important to the agency’s de novo determination,” the rule says.

Inspections for devices with critical or novel manufacturing processes will not occur to review compliance with the QSR. “Rather, the purpose of such an inspection is to gather information on critical and/or novel manufacturing processes, the methods and procedures used, and such additional information as may be necessary to assess the safety and effectiveness of a drug or biologic constituent part of a combination product,” the rule says. The information will help classify the device type by providing an understanding of the manufacturing processes (low to moderate risk) to determine if general controls and special controls can effectively mitigate the probable risks to health, and to determine if the product specifications can reasonably be met.

The rule provides more precise examples of the certain instances when an inspection will be required (begins page 22).