Fraudulent and Unreliable Laboratory Testing Data in Premarket Submissions

FDA Reminds Medical Device Manufacturers to Scrutinize Third-Party-Generated Data

FDA recently issued a Letter to Industry regarding medical device submissions that contain fraudulent and unreliable third-party testing data.  In this letter, FDA reminds industry that they must carefully evaluate third parties with whom they engage to conduct performance testing.  Ultimately, it is the responsibility of the sponsor or device manufacturer to qualify third parties that generate data and ensure that all information submitted to FDA is truthful and accurate.

Many sponsors likely do not realize that they have outsourced their project to an unaccredited or unreliable test laboratory. However, MED Institute has a robust Quality System and maintains numerous accreditations undergoing multiple annual audits to provide the highest quality work product to our clients. Here are some examples specific to MED Institute:

• MED Institute has provided data for numerous submissions to FDA over the course of 40+ years
• Perry Johnson Laboratory Accreditation (PJLA) accredited to ISO/IEC 17025:2017 and audited on an annual basis
• FDA Accreditation Scheme for Conformity Assessment (ASCA) accredited; There are only 101 companies ASCA accredited and MED Institute is one of them
• MED Institute actively participates on many international standard committees and contributes to the development and revision of numerous standards.
• BSI certified to ISO 13485:2016 and audited to ISO 14155:2020 and audited on an annual basis
• Medical Device Development Tool (MDDT) qualified by FDA for virtual MRI safety evaluations
• MED Institute publishes in peer-reviewed journals and presents abstracts at leading industry and academic conferences
• Collaborated with the Center for Devices and Radiological Health (CDRH) at FDA during a multi-year Research Collaboration Agreement (RCA) regarding the assessment of RF-induced heating of passive implants during MRI

MED Institute takes pride in the work we do for our clients. With over 250 accredited test methods, we are committed providing accurate and reliable data to help bring new medical products and therapies to market that are safe and effective for patients. Contact us today to discuss your project needs 855.463.1633 |  medinstitute.com.