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”).
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.
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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.
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.
Healthcare IT Today
MAY 18, 2023
Nutromics’s measurement solution will be available commercially in 2028. This diagnostic tool is a big advance, and won FDA approval in 2022. Having completed their clinical study, Cordio Medical is submitting the app for FDA approval. They plan many other applications for the Nutromics patch. This can save lives.
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.
SQA
OCTOBER 18, 2024
Processes and Practices Applicable to Bioresearch Monitoring Inspections, Draft Guidelines for Industry, 04 June 2024 The FDA is announcing the availability of draft guidelines for industry entitled Processes and Practices Applicable to Bioresearch Monitoring Inspections. The deadline to submit feedback for this plan is 25 July 2024.
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