Question

A key component of a new device for which a PMA is being prepared is manufactured by a second company. Without revealing proprietary information to the finished product manufacturer, how can the component manufacturer make critical information available to FDA for review?

A) Submit a Device Master File (MAF)
B) File its own PMA
C) Supply the applicable sections of the finished device manufacturer's PMA directly to FDA
D) Include a certification in the finished device manufacturer's PMA that the proprietary information meets FDA's requirements

Answer 1

The component manufacturer can submit a Device Master File (MAF) to the FDA as it contains proprietary information about the device component, which can be reviewed without revealing the details to other parties.

Step-by-step explanation:

To address the concern of a component manufacturer needing to make critical information available to FDA without revealing proprietary information to the finished product manufacturer, the appropriate course of action would be A) Submit a Device Master File (MAF). A Device Master File, commonly known as MAF, is a submission to the FDA that contains protected and proprietary information about materials, processes, or components used in the manufacture of a device or a drug. Because this information is submitted directly to the FDA, it can be reviewed without revealing the proprietary details to other parties, even the manufacturer of the finished product who incorporates the component into their medical device.

Different from the New Drug Application (NDA) used for drugs, which outlines manufacturing, packaging, and administration details post-approval, the Device Master File is specific to device components and relevant in the context of a Pre-Market Approval (PMA) application for medical devices. The MAF enables critical review by the FDA while ensuring confidentiality between the two companies.