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FDA Approvals of Medical Devices Under the De Novo Automatic Class 3 Regulations: An Opinion
2018
Biomedical Journal of Scientific & Technical Research
Preserved Fulltext
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.
doi:10.26717/bjstr.2018.08.001623
fatcat:fl4aq3udznc2rjmw66ij4fxa6y