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FDA Dataset Helps Firms Scrutinize Third-Party Chemistry Labs | Knobbe Martens

Medical devices that contact the human body undergo biocompatibility safety assessments prior to market release, including tests for physiochemical properties.  The Food and Drug...

More Lab Tests Will Soon Face Federal Scrutiny, FDA Says

FDA moves to regulate some tests it says may be unreliable

FDA Takes Action Aimed at Helping to Ensure the Safety and Effectiveness of Laboratory Developed Tests - Oskaloosa News

FDA finalizes lab developed test rule despite industry opposition

Healthcare

Insights from The Identity Jedi for shoring up healthcare's cybersecurity defenses

Ransomware and killware cyberattacks can pose lethal threats to hospitals and critical infrastructure.

FDA defends lab test rule, as critics fear industry upheaval

BioPharma

Enforcement Policy for Certain In Vitro Diagnostic Devices for Immediate Public Health Response in the Absence of a Declaration under Section 564

This draft guidance describes an enforcement policy for certain IVDs for immediate public health response in the absence of a declaration under section 564.

FDA Takes Action Aimed at Helping to Ensure the Safety and Effectiveness of Laboratory Developed Tests

Today, the U.S. Food and Drug Administration took action aimed at helping to ensure the safety and effectiveness of laboratory developed tests.

MIL-OSI USA: FDA Takes Action Aimed at Helping to Ensure the Safety and Effectiveness of Laboratory Developed Tests