2027 FDA Public Health 
HealthIT Answers
SEPTEMBER 27, 2023
Food and Drug Administration has released its comprehensive FDA Information Technology Strategy for Fiscal Years 2024 to 2027 (IT Strategy), marking a defining roadmap for the agency's technological advancement and the alignment with its broader public health mission. Berrellez - The U.S.
Healthcare Law Today
FEBRUARY 1, 2022
It also requires that the Secretary report to Congress on the state of the SNS, and to issue guidance and hold annual meetings with public health officials and stakeholders on how states, territories, and Tribes can access the SNS. Modernizes public health data through biosurveillance and infectious disease data collection.
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Hall Render
NOVEMBER 30, 2023
On September 29, 2023, the Food and Drug Administration (“FDA”) announced the issuance of a Notice of Proposed Rulemaking (the “Proposed Rule”) to expand the FDA’s regulatory scope over in vitro diagnostics products (“IVDs”) to specifically address Laboratory Developed Tests (“LDTs”).
Hall Render
JUNE 5, 2024
In April 2024, the Food and Drug Administration (“FDA”) issued a Final Rule amending the definition of in vitro diagnostics products (“IVDs”) found in 21 C.F.R. This phaseout is scheduled to occur over four years, starting from the publication date of the Final Rule on May 6, 2024.
SQA
FEBRUARY 15, 2023
Of interest is a reference to the FDA’s draft document “Computer Software Assurance for Production and Quality System Software,” which was recently published on 13 September 2022. A concerted and collaborative effort is essential to address this threat to global health, economies, and security effectively.
SQA
MAY 24, 2023
The deadline for reporting serious incidents not constituting serious public health threats, deaths, or unanticipated serious deteriorations in state of health was reduced to 15 calendar days. Following adoption by the European Council, the formal process of publication in the OJEU may begin, and typically takes up to 30 days.
SQA
MAY 24, 2023
The deadline for reporting serious incidents not constituting serious public health threats, deaths, or unanticipated serious deteriorations in state of health was reduced to 15 calendar days. Following adoption by the European Council, the formal process of publication in the OJEU may begin, and typically takes up to 30 days.
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