Special Report: Preparing for Stage 1 of the FDA’s LDTs Final Rule
Considerations for addressing compliance with Stage 1 of the FDA’s lab-developed tests final rule
FDA-lca
Subscribe today for access to
Articles and Reports
How the LDT Final Rule’s Exemptions Apply to Oncology Labs
Regulatory expert explores whether any exclusions might benefit cancer laboratories trying to navigate upcoming compliance deadlines
FDA Watch: FDA Approves Enhanced Cologuard Cancer Test
Test maker Exact Sciences says it expects Cologuard Plus to cut false positives by more than 30 percent
Liquid Biopsies Get FDA Attention
...
This content is for Paid Members only.
Register
Register
Already a member? Log in here
Congressional Leaders Query FDA and CMS about Theranos
...
This content is for Paid Members only.
Register
Register
Already a member? Log in here
FDA Guidance Addresses NGS Testing, Espousing Flexibility in Oversight
...
This content is for Paid Members only.
Register
Register
Already a member? Log in here
FDA’s LDT Oversight Framework Could Impact 60,000+ Tests
...
This content is for Paid Members only.
Register
Register
Already a member? Log in here
FDA’s 2016 Guidance Plans Include LDTs and Other Diagnostics Topics
...
This content is for Paid Members only.
Register
Register
Already a member? Log in here
FDA Workshop Addresses Security of Medical Devices
From - G2 Compliance Advisor
The U.S. Food and Drug Administration (FDA) is joining the cadre of government agencies calling attention to the cybersecurity risks of wireless, internet-and network-connected devices and…
FDA and CMS Address LDT Regulation Before Energy and Commerce Committee
...
This content is for Paid Members only.
Register
Register
Already a member? Log in here
FDA Details Oversight of Medical Applications On Smart Phones and Tablets
...
This content is for Paid Members only.
Register
Register
Already a member? Log in here