Fraudulent and Unreliable Testing Data – FDA Notice Why Accreditation Matters
The Corner Office
Wayne Moore
3/12/2024
We have been asked multiple times over the past two decades why Acertara goes to such pains and expense in testing diagnostic ultrasound probes. Two words say it all – The Patient. It is because of the patient that Acertara Labs testing facility sought to be accredited both through ISO/IEC 17025:2017 and more recently through the FDA’s ASCA accreditation program to be recognized as the finest ultrasound testing facility in the world. Our clients range from a one-person startup with a great product idea, to the largest OEMs in the world – and we don’t stop there. We have also tested ultrasound probes that NASA was sending to the international space station to use on astronauts – we were the first extraterrestrial probe testing company!
So, what, do you ask, is the FDA ASCA program and how does it fit into the medical device market? Excellent question! Simply put, the FDA ASCA program focuses on medical device manufacturers who require a 510(k) premarket notification and other regulatory reviews in order to sell their devices in the United States. Many people are surprised to learn that the FDA clears more than 3,000 devices per year through the 510(k) pathway. Due, in part, to that volume of submissions the FDA created the ASCA program to support more efficient and consistent FDA evaluations of manufacturers’ (OEMs) compliance with voluntary consensus standards. By utilizing ASCA-accredited laboratories such as Acertara for their ultrasound device and probe safety and performance testing, OEMs decrease the likelihood of significant clearance delays or additional questions from the FDA as their devices undergo review. The benefit to patients of these more efficient reviews can be the more rapid introduction of new life-saving technologies into the healthcare system. The patient benefits and that’s our goal.
Below you will read a recently FDA issued “letter to industry” regarding fraudulent and unreliable medical laboratory testing data being discovered by the FDA reviewers in more and more premarket submissions. They caution OEMs, amongst others, to scrutinize third-party generated data and select wisely the test labs that will be used. Acertara conducts all testing in our ISO/IEC 17025:2017 and FDA ASCA accredited lab located in Longmont, Colorado to produce data that is, as the FDA puts it, “truthful and accurate”.
Through our ISO/IEC 17025:2017 and FDA ASCA accredited testing for external and internal clients (we also use our accredited laboratory testing to verify and validate our probe repair processes), Acertara demonstrates its commitment to patient safety. It is worth meeting the stringent requirements of the ISO/IEC standard and the FDA regulations to do so!
Until next month,
Wayne
Fraudulent and Unreliable Laboratory Testing Data in Premarket Submissions: FDA Reminds Medical Device Manufacturers to Scrutinize Third Party-Generated Data
Date Issued: February 20, 2024
“The U.S. Food and Drug Administration (FDA) is reminding sponsors of device studies and manufacturers of devices (“device firms”) to carefully evaluate the third parties they engage to conduct performance testing and to independently verify all testing results before submitting to the FDA. 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. In recent years, the FDA has observed that an increasing number of entities that contract with device firms to conduct testing on medical devices (“third-party test labs”) are generating testing data that are fabricated, duplicated from other device submissions, or otherwise unreliable. When such data are submitted to the FDA, the agency is unable to rely on them to grant marketing authorization and it calls into question the data integrity of the entire file.
The FDA has identified an increase in submissions containing unreliable data generated by third-party test labs, including from numerous such facilities based in China and India. This alarming trend has resulted in the FDA being unable to reach a substantial equivalence determination or otherwise authorize marketing for medical devices whose submissions include such data. Sponsors and manufacturers making submissions are obviously directly impacted in these cases when the device cannot be authorized. An additional effect of these negative decisions is reduced access to new devices for patients and healthcare providers and potential disruption in the supply chains for devices. Device firms need to be diligent in order for this to stop.
To reverse the trend of unreliable data being submitted to the FDA, it is incumbent on device firms to take proactive steps to qualify third-party test labs and to closely scrutinize all testing data that a firm does not perform itself, especially relating to biocompatibility and other performance testing, that are included in a submission to the FDA. We acknowledge it may be difficult for individual device firms to know if certain data have been copied from an unrelated marketing submission, but we expect device firms to identify testing results that are improbable or impossible on their face or do not seem consistent with known information about the device. While the FDA encourages device firms to partner with third-party labs that have been voluntarily accredited under the Accreditation Scheme for Conformity Assessment (ASCA) program, doing such does not substitute for conducting an independent assessment of all third-party data.
To protect patients and healthcare providers from substandard products and ensure that U.S. patients have access to safe, effective, and high-quality medical devices, the FDA is pursuing various actions to identify and confront data integrity violations including through our Bioresearch Monitoring Program. At the same time, the FDA is calling upon the medical device industry to be vigilant and proactive about ensuring the integrity of all data they include in medical devicesubmissions(/inspections-compliance-enforcement-and-criminal-investigations/fda-bioresearchmonitoring-information/bioresearch-monitoring-program-information).”