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.

Doctors 91

Doctors FDA Hospitals Telemedicine 91

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.

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FDA Regulatory Compliance Compliance Governance 52

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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FDA Public Health Compliance Hospitals 40

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

Compliance 52

Compliance FDA Regulatory Compliance Governance 52

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. PCPC looks forward to working with the FDA and key stakeholders to implement this important legislation.

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US Department of Health and Human Services FDA COVID-19 World Health 40

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.

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Ransomware FDA Governance Hospitals 86

SQA

MAY 24, 2023

As in the past, the PCPC stands ready to collaborate with the FDA and other stakeholders to ensure any reorganization enables the beauty and personal care industry to continue to provide innovative, safe, and effective products while maintaining consumer trust. The PCPC looks forward to working with FDA Chief Scientist Namandjé Bumpus, Ph.D.,

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FDA Licensing Governance Compliance 40