The agency is reminding medical device companies to evaluate reliability of third-party testing before FDA submission citing uptick of fabricated, duplicated, and unreliable data.

Katie Hobbins, Managing Editor

February 21, 2024

2 Min Read
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FDA recently published a statement reminding medical device study sponsors and medical device manufacturers to evaluate third party’s contracted to conduct performance testing, urging independent verification of all testing results before submission to the agency.

“It is the responsibility of device firms to qualify third parties that generate data and to ensure that all information submitted to the FDA is truthful and accurate,” according to FDA.

The agency said it has identified an increase in submissions containing unreliable data from third-party test labs, including numerous facilities in China and India. These third-party labs are reportedly creating fabricated, duplicated, or otherwise unreliable data for device submissions which, in-turn, has resulted in FDA’s inability to reach substantial equivalence determinations or authorize marketing for devices which include the data. Additionally, identifying the unreliable data could further call into question the entire files data integrity, the statement wrote.

Device manufacturers and study sponsors, FDA noted, are directly impacted by these issues because the device will not be authorized, leading to reduced access to new technology for patients and healthcare providers, and potential supply chain disruptions.

To stop the trend, FDA is urging device study sponsors and manufacturers to take proactive steps to qualify third-party test labs, scrutinizing all testing data not undertaken by the device makers themselves, especially related to biocompatibility and other performance testing included in an FDA submission.

While the agency said it encourages device firms to partner with third-party labs that have been voluntarily accredited through the Accreditation Scheme for Conformity Assessment (ASCA) program, it is also imperative to conduct an independent assessment of all third-party data.

After acknowledging that it may be difficult for individual device companies to know if certain data has been copied from unrelated marketing submissions, FDA said it does, however, expect companies to identify testing results that are improbable, impossible, or do not seem consistent with known device information.

FDA is pursuing actions to identify and confront data reliability violations, including through its Bioresearch Monitoring Program and is calling upon the industry to be vigilant and proactive to ensure data integrity.

About the Author(s)

Katie Hobbins

Managing Editor, MD+DI

Katie Hobbins is managing editor for MD+DI and joined the team in July 2022. She boasts multiple previous editorial roles in print and multimedia medical journalism, including dermatology, medical aesthetics, and pediatric medicine. She graduated from Cleveland State University in 2018 with a bachelor's degree in journalism and promotional communications. She enjoys yoga, hand embroidery, and anything DIY. You can reach her at [email protected].

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