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Policy Updates

FDA Makes LDT Guidance Documents Available for Comment

On Oct. 3, the FDA released documents outlining the agency's risk-based plan for regulating laboratory-developed tests (LDTs) as well as its reporting requirements for LDTs and related adverse events. The documents are subject to a 120-day public comment period. Use the links below to access the agency's latest LDT regulation updates and download the documents.
» Follow LDT regulation updates from the FDA
» Download: Framework for Regulatory Oversight of LDTs
» Download: FDA Notification and Medical Device Reporting for LDTs

FDA Issues Final Guidance on In Vitro Companion Diagnostic Devices
The report pertains to devices that are used to guide safe and effective treatment of corresponding therapeutic products.
» Download the Report

21st Century Cures Invites Feedback on FDA's LDT Regulation Framework
The white paper invites responses to 11 issue areas as well as suggestions on the role of Congress in addressing these and related questions.
» View the Announcement


PMC News

PMC Suggests Guidances on Risk, CLIA Accompany LDT Framework

In its response letter to the U.S. House Energy and Commerce Committee's white paper on diagnostic test regulation, PMC suggests that FDA publish draft guidance documents on risk classification and Clinical Laboratory Improvement Amendments (CLIA) harmonization alongside a second draft of its framework for the regulation of laboratory-developed tests (LDTs).
» Download the Letter

PMC Summarizes Proposed Framework for LDT Regulation
In this blog post, PMC Executive Vice President Amy Miller provides an overview of FDA's proposed framework for LDT regulation.
» Read the Post

PMC Discusses Cost and Value
In this blog post, PMC Executive Vice President Amy Miller examines how to define and assess value in cancer care.
» Read the Post

PMC Continues Dialogue With Congress at Roundtable Discussion
On July 23, PMC President Edward Abrahams participated in a personalized medicine roundtable discussion with lawmakers.
» Watch the Discussion

PMC Engages CMS on APMs
PMC advocates for alternative payment models (APMs) that encourage personalized medicine in this letter to CMS.
» Download the Letter