Medical Device Manufacturers and the ASCA Pilot Program

In light of the rapid evolution of medical devices, the U.S. FDA has introduced an Accreditation Scheme for Conformity Assessment (ASCA) pilot program. This voluntary program seeks to increase confidence in test results as well as the consistency of information submitted to reduce the number of additional requests, evaluation time and delays to receiving FDA clearances, such as the 510(k) and De Novo review process. Learn about the program and why medical device manufacturers may want to consider participating.

Rapid product evolution brings more complex, connected medical devices to market each year. As a result, the FDA is working to advance the regulatory review process, which serves to demonstrate medical devices’ safety and effectiveness before being sold and used. For example, the 510(k) review process can take anywhere from 90 days to nearly a year, and the number of requests grows every day.

To ensure that patients have timely and continued access to safer, effective and high-quality medical devices, the FDA introduced the ASCA pilot program. Medical device manufacturers may choose to participate in this completely voluntary program, which involves selecting an ASCA-accredited laboratory to conduct testing to evaluate the registrants’ conformity to FDA consensus standards. Many manufacturers don’t have a clear understanding of the benefits of participating in this pilot program and how it will impact their products’ compliance with FDA standards for medical devices.

Benefits of ASCA participation

Currently a pilot program, ASCA seeks to increase confidence in test results and consistency of information submitted to reduce the number of additional requests, evaluation time and delays in the FDA regulatory review process. While the FDA does not promise a reduction in review cycle time, the new ASCA process will hopefully pave the way to a more efficient, streamlined process in the future.

Some of the benefits to participating manufacturers include:

• Increased confidence in test results
• Provision of test results and other information in a preferred format as outlined by the ASCA template submission form
• Greater predictability of compliance due to the comprehensive nature of data provided
• Increased time and money savings due to reduced retesting with limited documentation requirements

“Consistency is key to streamlining the review processes, such as 510(k). By providing all the information the reviewer needs in a single, consistent and complete format, it’s possible to reduce back-and-forth requests for additional information and clarification that can delay the process,” said Pamela Gwynn, principal engineer in UL’s Medical Device Testing and Conformity division. She works with dozens of customers to help them through this process.

Based on the program’s success and lessons learned, the ASCA program could easily provide the basis for modernizing the current review process, including the 510(k) process. Manufacturers that have engaged in the pilot may position themselves for streamlined adoption of the next generation of requirements.

Choosing a testing partner

In April 2021, the FDA announced the initial list of ASCA-accredited testing laboratories, which have undergone assessments to ensure that they demonstrate competence in testing to the safety and compliance standards relevant to medical devices. An experienced provider of medical equipment testing and support for filing 501(k) applications, UL earned that accreditation for laboratories across the U.S., Europe and Asia:

• Brea, California
• Fremont, California
• Mounds View, Minnesota
• Northbrook, Illinois
• Melville, New York
• Research Triangle Park, North Carolina
• Neu Isenburg, Germany
• Milan, Italy
• Warsaw, Poland
• Ise-Shi Mie-Ken, Japan
• Suzhou, China
• Guangzhou, China
• Taiwan

UL’s specialized qualifications for serving manufacturers of medical devices go far beyond ASCA accreditation.

The complexity of medical devices still challenges even the most streamlined compliance processes. With dozens of safety and performance standards applicable to medical devices, navigating the complex regulatory landscape can seem daunting. The ASCA pilot program places the burden of selecting appropriate standards applicable to any specific medical device on the manufacturer. For this reason, selecting an experienced testing partner is critical. UL has been a trusted name in safety and compliance testing for medical devices for more than two decades.

UL conducts testing according to international harmonized standards, assessing manufacturers’ devices for conformity with multiple markets simultaneously. This saves significant time and money by mapping a test plan that leverages each test to meet the maximum number of global market regulatory requirements. A trusted name in safety and compliance testing for medical devices, UL’s ASCA-accredited testing laboratories are also ISO/IEC 17025 accredited and staffed with experts dedicated exclusively to medical devices.

As you prepare to navigate the evolving regulatory landscape for healthcare and medical products, UL is here to help. Learn more about our capabilities and testing for medical devices.