Manufacturers must remain “vigilant” to ensure device data integrity

Retrieved on: 2024-03-05 17:28:49

Tags for this article:

Pharmaceuticals policy

Food and Drug Administration

Medical devices

Regulation of medical devices

Clinical research

Medical device

Pharmacovigilance

Single Use Medical Device Reprocessing

Food and Drug Administration Amendments Act

u.s. food and drug administration

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Manufacturers must remain “vigilant” to ensure device data integrity. View article details on HISWAI: https://www.europeanpharmaceuticalreview.com/news/217601/medical-device-manufacturers-must-remain-vigilant-to-ensure-data-integrity/

Summary

MedTech article emphasizes FDA concerns over data integrity in medical device premarket submissions, highlighting increased fraudulent data incidences and stressing manufacturer vigilance in verifying third-party test results, relevant to medical device regulations and ensuring device safety and effectiveness.

Article found on: www.europeanpharmaceuticalreview.com

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