Easing Medical Device Regulatory Oversight: The FDA and Testing Amidst the COVID-19 Pandemic.
Am J Law Med
; 47(2-3): 291-326, 2021 07.
Article
in English
| MEDLINE | ID: covidwho-1361585
ABSTRACT
The FDA already subjects most medical devices to much less stringent approval requirements than drugs and biologics, and attempts to speed up rollout during the COVID crisis have been problematic. Agency decisions, including to allow antibody test marketing without emergency use authorization or review, and the back-and-forth guidance on laboratory-developed tests, have met harsh criticism and unreliable results. Though the long-term results of these decisions are unclear, the FDA's credibility, reliability, and commitment to safety are threatened by even further lessening medical device regulatory oversight during the coronavirus pandemic. The relaxed and fix-it-later approach to many of the FDA's public health emergency decisions regarding medical devices reflect the ongoing criticisms of medical device regulation in general, specifically the 510(k) process and laboratory developed test regulation, offering a point of reflection towards reform. Adaptive legislation and a risk-based and evidentiary approach to premarket and postmarket review can begin to address these issues both generally and in an emergency context.
Full text:
Available
Collection:
International databases
Database:
MEDLINE
Main subject:
United States Food and Drug Administration
/
Device Approval
/
Government Regulation
/
Medical Device Legislation
Type of study:
Prognostic study
Limits:
Humans
Country/Region as subject:
North America
Language:
English
Journal:
Am J Law Med
Year:
2021
Document Type:
Article
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