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Diagnostic Testing and Emerging Technologies

LAB COMPLIANCE ADVISOR

LABORATORY INDUSTRY REPORT

NATIONAL LAB REPORTER

The Year in Lab Compliance: The 6 Biggest Stories of 2022

The Year in Lab Compliance: The 6 Biggest Stories of 2022

by Glenn S. Demby | Dec 14, 2022 | Compliance-nir, National Lab Reporter

The year was certainly an interesting one in terms of regulatory change in the medical laboratory space.

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Want Breakthrough Device Designation? You’ll Need to Consider Health Equity

Want Breakthrough Device Designation? You’ll Need to Consider Health Equity

by Glenn S. Demby | Nov 21, 2022 | Diagnostic Testing and Emerging Technologies, FDA-dtet

In draft guidance, the FDA is proposing that medical device makers will need to consider how accessible their products are to underserved populations.

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FDA to Consider Health Disparities in Granting Breakthrough Device Designation

FDA to Consider Health Disparities in Granting Breakthrough Device Designation

by Glenn S. Demby | Nov 14, 2022 | News

Medical device makers will have to show that their products will be accessible to disadvantaged populations.

How COVID-19 Transformed Healthcare Delivery

How COVID-19 Transformed Healthcare Delivery

by Waqaas Al-Siddiq | Oct 14, 2022 | Industry Perspectives

The pandemic came with great pain and suffering for many, but it also allowed telehealth and other technologies to flourish.

HHS’ Proposed New Anti-Discrimination Rule & What You Can Do to Comply with It

HHS’ Proposed New Anti-Discrimination Rule & What You Can Do to Comply with It

by Glenn S. Demby | Oct 14, 2022 | Health care reform-nir, National Lab Reporter

What you need to know about the 308-page proposed rule and its potential impact on your lab, along with a basic strategy to implement it.

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