FDA identified new regulatory priorities for medical devices in its fiscal 2020 budget justification document, including proposals to safeguard against shortages of essential devices and to compel manufacturers to address cybersecurity.
The document offers more detail on the administration’s budget proposal released last week.
The agency also floated establishing alternative pathways to the premarket notification 510(k) process for certain devices in the nearly 400-page Justification of Estimates for Appropriations Committees report.
Another proposal would change the process for imposing special controls to allow use of an administrative order rather than regulation.
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