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

FDA Issues Draft Guidance on Expedited Approval for Select Medical Devices
The report pertains to devices that treat life-threatening or irreversibly debilitating illnesses.
» Download the Report

PMC News

PMC Continues Dialogue With Congress at Roundtable Discussion

After PMC submitted a letter to the U.S. House Energy and Commerce Committee on June 1, PMC President Edward Abrahams participated in a personalized medicine roundtable discussion with the Committee on July 23.
» Watch the Discussion

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 Provides Expert Analysis on Personalized Medicine Education
Alongside her colleagues, PMC Executive Vice President Amy Miller speculates on what the public needs to know about personalized medicine.
» Explore the Conversation

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