CDRH lab chief encourages stakeholders to suggest regulatory science tools

COLLEGE PARK, MD – The head of the Center for Devices and Radiological Health’s (CDRH) laboratory research office said the center has been building a library of regulatory tools that the medtech industry can use to develop new products. He also said they are open to hearing from stakeholders about what new regulatory tools they should work on that can make the biggest impact on bringing promising products to markets.

Ed Margerrison, director of the Office of Science and Engineering Laboratories (OSEL), spoke at the REdI conference on 29 June about what the team of scientists and engineers who work under him do to help develop regulatory science tools. He noted that his office consists of about 20 programs, of which some are based around specific disease areas, such as cardiovascular and orthopedic devices, but others are more technology-based and cut across disease areas.

Margerrison said that while his office in the past was more focused on publishing papers that could be used by industry to inform how to assess their products, his office today is more focused on pushing out regulatory science tools that they hope are more practical and tangible across the whole product lifecycle of a device. He said such tools could include lab methods, training sets for artificial intelligence (AI) enabled products, and tools to validate AI models.

Margerrison said that what keeps him up at night the most is if sponsors come to CDRH with promising products that could save or improve people's quality of life, but the agency doesn’t have the tools or knowledge to evaluate them.

"What we need to do is to make sure our reviewers know what questions they need to ask, and similarly what questions they don't need to ask," he said. "That really is the function of what we're trying to do in my part of the center."

According to Margerrison, developing standards is an important aspect of OSEL's mission. He noted that if CDRH reviewers can rely on standards to understand how a device has been tested, they can halve the number of questions they have about a product.

“They don't need to ask how has it been tested and how good is it, because the first parts are answered,” he added. “We can really then focus as reviewers on how good the device is, and that's really important for our reviewers.”

Over the past three years ago, Margerison said that OSEL has developed a growing catalog of RSTs to help evaluate a product's safety and efficacy. So far, the agency has added about 150 such tools to the catalog, and his vision is that industry, and especially start-ups, will use it as a central library to evaluate new products.

“What we don't want to do is to have [industry] invest too much money in method development because if you run out of money, the lights go off and they don't come back on, and that's a valuable lesson that we understand at CDRH,” said Margerrison. “We're trying to do whatever we can to keep those early-stage companies alive.”

During the Q&A portion of the talk, Margerrison said that his office welcomes suggestions for regulatory science tools that CDRH could develop. He noted that they only have about 130 scientists who cannot take on all the workload, so they are looking to collaborate on such projects.

“We have a lot of collaborations with industry already, we have a lot of collaborations with academia, but we're looking for big collaborations and less interested in tiny projects," he said. "We welcome dialogue at any stage, [but] I want to know where the big problems are to solve."

Margerrison also added that regulatory science tools are not mandatory, and sponsors should use the method that they think is best to evaluate their product.

Regulatory Science Tools Catalog

CDRH lab chief encourages stakeholders to suggest regulatory science tools

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