Specialty Fabrics Review November 2019 - 54

FOCUS

ADVANCED TEXTILES

FDA-approved Celliant® has
miniaturized minerals that
absorb heat and give off infrared
light to improve local circulation.
The minerals can be added to
nylon and then blended with
materials such as wool, cotton,
Lycra®, Tencel™ and others.
Photo: Hologenix LLC.

Quality and cooperation
The value and limitations of medical device master files.
BY ELAINE DUNCAN

What's a device
master file?
An MAF (device master file) is a
document filed with the Food and Drug
Administration (FDA) that offers a way
for a contractor to preserve proprietary
information. With different levels of
access, the supplier can limit exposure
and identify itself in different ways to
different customers.
For more information, visit
www.fda.gov/medical-devices/
premarket-approval-pma/master-files
and www.paladinmedical.com

54 REVIEW NOVEMBER 2019

edical device master files, known as MAFs, have value for textile contract manufacturers
and the medical device developer in many ways, but there are some practical
limitations. Most medical device manufacturers that incorporate a medical textile
into their products will seek a knowledgeable textile contractor who can address the quality
system needs of medical products. But some textile medical devices are built from the ground
up by the textile contractor, so device producers are looking for a knowledgeable partner.
When a textile contractor commits to a U.S. Food and Drug Administration (FDA) MAF,
the medical device producer can anticipate a facilitated medical device premarket application.
This is the application that provides scientific, regulatory documentation to the FDA to
demonstrate the safety and effectiveness of a new device.
TEXTILE SUPPLIERS AND THE FDA
From its inception, the FDA guidance document for the device master file submission said
that the MAF would "not be accepted if it was not substantive in nature and does not contain
information that may be reasonably regarded as trade secret or confidential." Originally
thought to be of value only for a premarket approval application (PMA) or investigational
device exemption (IDE) application, a master file now has broader utility.
Regardless of the type of premarket submission the medical device producer may require,
allowing the FDA to have access to proprietary information from the component supplier
can enhance the quality of the overall review process for the FDA.
The textile contract manufacturer has a great deal of intrinsic proprietary information to
protect, yet the textile chemicals and mechanical processes can affect the safety of a medical
device. Some contractors have been in business for many decades, and even the machines in
use are considered trade secrets.
It is not at all uncommon for the FDA to consider a full range of processes that may
contribute risk to the quality of the final device and, thus, it will want to understand more
about the overall risk mitigations in place for the textile when reviewing the final medical
device application.
If every time an FDA application is filed the entire playbook of the textile contractor were to
be made available, it would increase the potential for the contractor's proprietary information
to become inadvertently disclosed. Despite the good intentions of regulatory departments to
safeguard submission files, there are simply many opportunities for disclosures.

http://www.fda.gov/medical-devices/ http://www.paladinmedical.com

Specialty Fabrics Review November 2019

Table of Contents for the Digital Edition of Specialty Fabrics Review November 2019