Medical Design Briefs - May 2021 - 4

FROM

THE EDITOR

FDA Catalog of Tools Helps
Accelerate Device Development

DA has created a " Catalog of Regulatory
Science Tools, " in which it provides a
comprehensive list of peer-reviewed resources for medical device developers. It
are intended to offer guidance where no
standard is available and where no qualified tool is offered through FDA's Medical
Device Development Tools program.

The methods presented in the catalog are meant to expand the scope
of existing innovative science-based
approaches that can " improve the
development and assessment of emerging medical technologies. " To help
medical device developers, the catalog
includes more than 100 tools, including
laboratory methods, tissue-mimicking
phantoms, and computational modelling and simulations.

The catalog " reduces the need for
device developers to design ad-hoc test
methods and allow them to focus their
limited resources on how well their new
product works, not how well it may be tested, " notes CDRH director Jeffrey Shuren,
MD, JD, in a recent FDA Voices op-ed. " Adhoc testing can slow the process of bringing innovative devices to market because
the developer must develop and validate a
testing methodology in addition to developing a new product. " Shuren adds that
these resources offer a common set of
methodologies and therefore help to
streamline the regulatory review process
for both the innovators and the regulators.
" Over time we would expect the most
useful regulatory science tools to progress through the qualification process to
become fully fledged MDDTs, " he says.
" These methodologies complement FDArecognized standards and qualified
MDDTs. They represent an important
contribution to reducing risk in all stages
of product development and are particularly important to the early inventors and
innovators, who often don't have the
means to evaluate their systems. In addition to helping device developers identify
appropriate tools for their needs, the catalog entries include detailed instructions
for use and, where appropriate, reference to the original peer reviewed source
for further detail. "
To become part of FDA's official
MDDT toolbox, FDA must evaluate the
tool and ensure that it " concurs with
available supporting evidence that the
tool produces scientifically plausible
measurements and works as intended
within the specified context of use. "
Why a toolbox of resources? The use of
consensus standards can provide clearer
regulatory expectations and facilitate market entry. Shuren acknowledges that while
standards are critical, the slow pace of standards development puts a heavy burden
on the innovators to create the tools to
properly evaluate a device category.
" Standards take a long time to gain
consensus and often are not approved
until the particular medical device category is well established, which means
that early developers do a lot of the
'heavy lifting,' " Shuren says.
Sherrie Trigg
Editor and Director of Medical Content
To access the Catalog of Regulatory Science
Tools, go to http://bit.ly/fda-toolbox.

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Medical Design Briefs, May 2021

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Medical Design Briefs - May 2021

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