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. The name and address of manufacturers provided by the company on its establishment license application were not accurate.

FDA 40

FDA Licensing Governance Compliance 40

Health Law Advisor

AUGUST 10, 2023

5] But that Interstate Commerce Clause needs to be viewed also in balance with the 10th Amendment of the Constitution, which reserves to the states any powers not delegated to the federal government. Implementing a Constitutional limit, FDA does not regulate a licensed practitioner who makes devices for use in his or her own practice.

FDA 98

FDA Licensing Hospitals Medicaid 98

SQA

FEBRUARY 26, 2024

This standard is a globally recognized standard that provides guidelines for the governance and management of AI technologies. These are requirements of the Therapeutic Goods (Medical Devices) Regulations 2002. Schedule 10 lists substances of such danger to public health as to warrant their prohibition from supply and use.

FDA 52

FDA Compliance COVID-19 Public Health 52