Healthcare IT Today
JUNE 27, 2023
Food and Drug Administration (FDA) has recognized the problem and issued multiple guidance documents over the years—as recently as this March —to ensure the cybersecurity of medical devices. Although none of the FDA recommendations are legally enforceable, device manufacturers no longer have a choice but to comply.
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”).
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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. Stage 3: Effective May 6, 2027 Three years after the Final Rule’s publication, the FDA will enforce all remaining quality system requirements (under 21 C.F.R.
Dot Compliance
JUNE 16, 2022
The two most relevant quality regulations for medical device manufacturers are the FDA 21 CFR Part 820 and the ISO 13485:2016. The QMS supports the manufacturers, leading to ISO confirmation and FDA compliance. The FDA 21 CFR Part 820 is the mandatory standard for medical devices distributed in the US.
Dot Compliance
JANUARY 14, 2022
between 2021, and 2028. FDA’s Safer Technologies Program (SteP) for Medical Devices. The Safer Technologies Program (SteP) is a new, voluntary FDA program for medical devices and device-led combination products that enhance the safety of treatments for non-threatening conditions. It’s currently worth $7.7
Health Populi
MAY 20, 2024
The annual report details trends in health services utilization, the use of prescription drugs, patient financing of those costs, the drivers underpinning the medicines spending, and an outlook to 2028. Oncology and obesity will drive significant growth through 2028, IQVIA expects.
HIT Consultant
FEBRUARY 22, 2022
Simple-to-use and portable consumer EKG devices that are FDA-cleared allow patients to capture this information at home and as symptoms occur, providing another window into the patient’s health that goes beyond the four walls of the traditional healthcare provider.
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