HIPAA Journal

NOVEMBER 17, 2022

HIPAA Journal is conducting interviews with healthcare professionals and service providers to find out more about their compliance journeys, how the HIPAA Rules have affected their working lives, and the successes and challenges they have faced with HIPAA compliance. Tell the readers about your career in the healthcare industry.

Governance 105

Governance HIPAA Compliance Nursing Homes 105

SQA

FEBRUARY 22, 2021

Compliance with UDI requirements will now be enforced for the first batch of devices in the agency’s phased implementation plan. Since the introduction of the exemption in 2002, the technology and manufacturing processes used to produce medical devices have changed dramatically.

COVID-19 52

COVID-19 Compliance Licensing Governance 52

Health Law Advisor

AUGUST 10, 2023

FDA specifically identified the following as not having to register as device manufacturers: Licensed practitioners, including physicians, dentists, and optometrists, who manufacture or otherwise alter devices solely for use in their practice. [8] 8] We could go on, but hopefully you get the gist.

FDA 98

FDA Licensing Hospitals Medicaid 98

SQA

SEPTEMBER 2, 2022

The Regulations were first issued with immediate effect in 2002 and were later revised in 2016. Good Practice Guide: Membrane Based WFI Systems, May 2002. ISPE Good Practice Guide: Critical Utilities GMP Compliance. Affected needle kits should be destroyed in compliance with the health care institution’s process for disposal.

FDA 91

FDA COVID-19 Nursing Homes Public Health 91

SQA

DECEMBER 16, 2022

China’s Center for Medical Device Evaluation (CMDE) Update Compliance Guidelines and Recommended Paths for Clinical Evaluation Paths for Certain Medical Devices, 25 July 2022. 29 of 2022 , Technical Guidelines for Compliance with the Essential Principles of Medical Device Safety and Performance. CMDE Announcement No.

FDA 40

FDA Compliance COVID-19 Licensing 40

SQA

MAY 24, 2023

The vote occurred on 16 February 2023 following a plenary meeting of the European Parliament, and represents a significant step towards a formal extension of MDR and IVDR compliance deadlines for some device manufacturers. 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

SQA

MAY 24, 2023

The vote occurred on 16 February 2023 following a plenary meeting of the European Parliament, and represents a significant step towards a formal extension of MDR and IVDR compliance deadlines for some device manufacturers. The written procedure for recall was inadequate and this procedure had not been implemented.

FDA 40

FDA Licensing Governance Compliance 40