Comparative Study of Pre-Market Approval Process and Denovo Process for Medical Devices

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Akash Dambal
Harrison Michael Zaphrey
M. P. Venkatesh
Kaushik Devaraju
T. M. Pramod Kumar

Abstract

FDA’s Center for Devices and Radiological Health (CDRH) is responsible for regulating firms who manufacture, repackage, relabel, and/or import medical devices sold in the United States. Regulatory control increases from Class I to Class III. Most Class I devices are exempt from Premarket Notification 510(k); most Class II devices require Pre-market Notification 510(k); and most Class III devices require Pre-market Approval.The Food and Drug Administration Modernization Act of 1997 (FDAMA) added the De Novo classification option as an alternate pathway to classify novel medical devices that had automatically been placed in Class III after receiving a “not substantially equivalent” determination in response to a pre-market notification [510(k)] submission.Class III Devices are those considered as high risk along these lines requiring the regularly lengthier Pre-market Approval (PMA) process. The new De Novo process was designed to usher through any new device that was both Unprecedented (novel) and Low to moderate risk (or with a risk that was easily mitigated). The most inventive gadgets are considered high-hazard due to the non-attendance of equivalent items and follow either the De Novo or PMA path. Truly high-risk devices, in which deficient data exists to decide if general and special controls are sufficient to give sensible attestation of the item’s safety and effectiveness, follow the PMA pathway. Novel devices that do not have a predicate are classified in the highest risk class,despite the level of genuine risk it postures or the capacity of general and special controls to guarantee safety and effectiveness. The De Novo process allows these novel devices with low to moderate risk to be reclassified from a high-risk class, which requires a PMA.

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How to Cite
1.
Dambal A, Zaphrey H, Venkatesh M, Devaraju K, Pramod Kumar T. Comparative Study of Pre-Market Approval Process and Denovo Process for Medical Devices. IJPQA [Internet]. 25Jan.2013 [cited 2Jul.2020];11(01):74-2. Available from: https://www.ijpqa.com/index.php/IJPQA/article/view/983
Section
Research Article