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FDA Cannot Claim Regulatory Authority Over LDTs – But Labs Must Be Mindful, and Public Health Remains a Priority

by admin | Aug 24, 2020 | News

FDA Cannot Claim Regulatory Authority Over LDTs – But Labs Must Be Mindful, and Public Health Remains a Priority On August 19, 2020, HHS settled a debate that began nearly 30 years ago: FDA cannot regulate laboratory developed tests (LDTs) until and unless the agency...

Opportunity for Stakeholders to Impact FDA’s “Non-Device” Software Report

by admin | Jul 15, 2020 | News

Opportunity for Stakeholders to Impact FDA’s “Non-Device” Software Report There is still time for stakeholders to impact FDA’s 2020 update to its congressionally mandated report on best practices for “non-device” software, i.e., software functions excluded from the...

Recent Posts

  • Christine P. Bump to Speak at FDLI Enforcement Conference
  • FDA Cannot Claim Regulatory Authority Over LDTs – But Labs Must Be Mindful, and Public Health Remains a Priority
  • Opportunity for Stakeholders to Impact FDA’s “Non-Device” Software Report
  • Penn Avenue Law & Policy Evaluates COVID-19 Tests for Healthcare Client

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