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OpinionOpen Access

FDA Approvals of Medical Devices Under the De Novo Automatic Class 3 Regulations: An Opinion

Volume 8 - Issue 2

Michael AB Naafs*

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    • Dutch Internist, Endocrinologist, Health Consultant at Naafs, International Health Consultancy, Rhodoslaan Netherlands

    *Corresponding author: Michael AB Naafs, Dutch Internist-Endocrinologist, Health Consultant at Naafs, International Health Consultancy, Rhodoslaan 20,7577KN, Oldenzaal, The Netherlands

Received: August 18, 2018;   Published: August 22, 2018

DOI: 10.26717/BJSTR.2018.08.001623

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The new FDA class 3 automatic medical devices regulations were recently introduced to meet criticism of all sides on the past regulations. An evolving Essure scandal accelerated the launching of this ambitious new plan. Unfortunately, the last FDA approvals, a transcranial magnetic deep brain stimulation system (TMS) and a vaginal hormonal contraceptive ring, don’t reflect this new wave.

Keywords: Cervical Intraepithelial Neoplasia; Repair Process

Abstract | Introduction | Conclusion | References |