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Healthcare › Food and Drug Administration (FDA) › Recordkeeping Requirements

Wiley Rein LLP

CISA’s Proposed Cyber Incident Reporting Requirements Would Hit a Range of Industries and Sectors

Wiley Rein LLP on

The U.S. Department of Homeland Security’s (DHS) Cybersecurity and Infrastructure Security Agency (CISA) is publishing a proposed rule (Proposal or NPRM) that will require broad segments of industry to meet onerous and quick...more

Stinson LLP

FDA Eases Medical Evaluation and Recordkeeping Requirements for Hearing Aids

Stinson LLP on

On Wednesday, the Food and Drug Administration (FDA) released a new guidance document indicating that it will not enforce the medical evaluation and recordkeeping requirements (21 CFR §801.421(a) and (d)) prior to the...more

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