FDA has created a “Catalog of Regulatory Science Tools,” in which it provides a comprehensive list of peer-reviewed resources for medical device developers. It is 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. “Ad-hoc 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 FDA-recognized 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.
Editor and Director of Medical Content
To access the Catalog of Regulatory Science Tools, go here .