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New FDA Program Could Help Standardize Regulatory Submissions


NEW YORK – A new program from the US Food and Drug Administration could speed up the process for receiving regulatory clearance and alleviate headaches for diagnostic test manufacturers.

The Accreditation Scheme for Conformity Assessment, or ASCA — which has been in the works for the past couple of years but released an initial list of laboratories covered under it only last month — grants recognition to accreditation bodies that allows them to accredit testing labs to perform premarket testing for medical device manufacturers.

Scott Colburn, director of the Standards and Conformity Assessment Program at the FDA's Center for Devices and Radiological Health, said the pilot program is a "modernization approach" intended to add efficiency to the agency's premarket submission process.

Under the program, a medical device manufacturer can have an accredited laboratory perform testing for its products for premarket submissions to the FDA in two areas, biocompatibility and basic safety. To meet ASCA standards, a product must abide by international safety standards as well as additional ASCA-specific standards that assess certain kinds of testing methods, Colburn said.

Some of the major additions above what the international standards require are a focus on training and equipment requirements, method validation, and reporting, said Tracy Szerszen, president of Perry Johnson Laboratory Accreditation, one of the ASCA-recognized accreditation bodies.

The agency began building the scheme for the program in 2018 and worked with other regulatory bodies that have similar standards programs, such as the Occupational Safety and Health Administration.

Through interagency communications about standards and policies, as well as meetings with stakeholders such as accreditation bodies, laboratories, and device manufacturers, the agency decided to focus on biocompatibility and basic safety because those two standards could impact a wide variety of products, Colburn said. The program currently looks at more than 80 standards, he added.

Part of the reason for the creation of the program is a general misunderstanding of what the FDA is looking for in a premarket submission, he said. As a result, there is back-and-forth between the FDA and the manufacturer as they work out what's needed to continue on the regulatory pathway, which takes time and resources.

With the addition of accredited labs that have experience performing this testing, the process can be streamlined. According to Jack Steiner, operations manager at UL, formerly Underwriters Laboratories, one of the accredited labs, test reports from manufacturers to the FDA could be hundreds of pages in different formats depending on the lab and manufacturer, leading to a "long, drawn-out process."

The pilot program, however, has the laboratory submit a report in a specific format to reduce the length of that process.

When a manufacturer approaches a lab with its product, the two parties develop a test plan, with the lab helping to guide the process. The laboratory then performs the testing using the plan, documenting the process. It issues a summary test report following guidance from the FDA that includes basic information on the product, its essential performance, and the use environment, Steiner said.

The report includes which parts of the standards were tested, if and where the product failed, any modifications that were made or need to be made, and which configurations of the product were tested.

A reviewer from the FDA then looks at the report and determines whether the lab's protocol and training are sufficient, and a manufacturer signs a declaration of conformity saying it's the responsible party for the product and discussing any limitations of the product. Then the manufacturer sends its premarket submission to the FDA for further review.

To be accredited, laboratories had to be audited by accreditation bodies to ensure they met general lab standards and receive an expansion of scope for the ASCA standards, Steiner said. While third-party accreditors that received ASCA recognition are in charge of accrediting, the FDA can also audit the labs themselves if there are any issues with the reports a lab is submitting.

Accreditation bodies also had to apply to be recognized by the program, showing what they were qualified to look for and that their accreditors underwent specific training. When accrediting a lab, they look at a variety of different aspects, including the lab's record keeping, personnel training, equipment, data, and reporting criteria, Szerszen said

Kelli Ramos, technical program manager of medical/general testing at PJLA, said that receiving ASCA accreditation "speaks highly about the operations of a medical device testing laboratory in regard to operating under a standard of good laboratory practice." Ramos added that “medical device testing laboratories are likely to see an increase in business once they become accredited and accepted into the ASCA Pilot program," which could be "due to the recognition the FDA provides by publishing the laboratory on their website."

Colburn noted that the program is entirely voluntary, but there are benefits for both labs and manufacturers in participating. Labs can learn what regulatory bodies want to see and learn how to better set up their standard operating procedures while also having clearly defined responsibilities. Labs want "that gold star" of accreditation, Szerszen said. Manufacturers, meanwhile, can get help if they're new to FDA processes or if they've had issues in the past, Steiner said.

Bill Bisenius, president and cofounder of North Carolina-based laboratory Certifigroup, said that while the FDA was not promising a benefit, his lab was "hoping there's some upside" to being in the program. He noted that the FDA likely wanted to divert its attention to more complicated issues rather than spending its time dealing with delays in premarket submissions. The agency also may not have enough time, people, or money to spend on the basics of these submissions.

He added that although the FDA was not guaranteeing faster turnaround times, allowing third-party labs to help with the submission process could speed up reviews.

Bisenius echoed Steiner's assessment that manufacturers don't always know what regulatory bodies are looking for and said his lab can work as a team with them to "help them get to that finish line." Many manufacturers think creating the test is all they need to do, but there are construction requirements and other standards to be met.

Bisenius said that often products need to be reworked multiple times before they're ready for submission, and labs can serve as teachers for the manufacturers.

Steiner said that his lab has seen a lot of interest from manufacturers as a result of the accreditation, although there is one challenge of the program — labs can only use US-based accreditors for the program. Some UL labs had accreditation from bodies in China, so they needed to switch the accreditation to join the program.

Another challenge Bisenius noted is a lack of promotion from the FDA and the need for labs to market the program to manufacturers, although Colburn said the FDA was working with trade associations such as AdvaMed and providing webinars to get the word out.

The program is still in its early stages, but if it's successful Colburn said it could expand to more standards and help improve international standard development.

"The fact that we have a huge interest from the testing laboratory and accreditation body community already, we feel very confident that the foundation has been established so far," Colburn said.