FDA Takes Shot Across the Bow with LDT Rulemaking
The FDA has issued proposed LDT rulemaking. Laboratories have an opportunity to make comments before it becomes official.
The FDA has issued proposed LDT rulemaking. Laboratories have an opportunity to make comments before it becomes official.
In CLP's July cover story, we’re examining how the proposed VALID regulations will affect the laboratory industry and society as a whole.
The i.C3 monitors the temperature inside a laboratory refrigerator or freezer and activates alarms if the temperature rises or falls outside of the acceptable range.
I want to take a moment to reaffirm FDA’s commitment to transparency around the EUA process and share some updates on our plan to provide more information about FDA’s decisions to issue, revise or revoke EUAs for drugs and biological products, including vaccines.
Read MoreThe changes make it easier to navigate to questions by topic.
Read MoreThe FDA has issued and immediately implemented a new guidance: Enforcement Policy for Modifications to FDA-Cleared Molecular Influenza and RSV Tests During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.
Read MoreToday, the FDA will host a virtual Town Hall for clinical laboratories and commercial manufacturers that are developing or have developed diagnostic tests for SARS-CoV-2.
Read MoreThe “Laboratory Quick Start Guide for CLIA Certification” outlines all of the necessary steps laboratories must follow.
Read MoreCMS’s quick-start guide helps laboratories with the application process for CLIA certification and includes information on the expedited review process.
Read MoreA memo recommends that facilities conducting patient lab tests use authorized detection antigens to prevent the spread of covid-19 in nursing homes.
Read MoreThe page offers resources such as emergency use authorization templates and FAQs regarding surveillance testing and the testing of asymptomatic individuals.
Read MoreThe virtual laboratory survey process consists of three parts: documentation, review, and a video conference.
Read MoreThe template will help developers submit EUA requests for covid-19 diagnostics that can be performed entirely in settings such as homes, offices, or schools.
Read MoreOn July 29, the FDA will host a virtual Town Hall for clinical labs and commercial manufacturers involved in developing diagnostic tests for SARS-CoV-2.
Read MoreThe updates clarify FDA’s previous recommendations for demonstrating clinical performance and presenting validation data and provide new recommendations.
Read MoreAI-driven software can help labs expertly navigate the prior authorization landscape.
Read MoreIf the agency’s proposed reclassification is finalized, devices of this type may go through the 510(k) pathway for clearance instead of the premarket approval (PMA) pathway.
Read MoreThe waiver will provide temporary relief from federal regulations requiring pathologists to render primary diagnoses onsite at healthcare facilities.
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