USA – FDA updates Q-Sub guidance ahead of new Pre-Sub draft guidance
The US Food and Drug Administration has updated its final guidance on its Q-Submission program in line with changes negotiated in the recent medical...
USA – FDA’s CDRH releases list of proposed guidances for FY 2024
The US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) has named the guidance documents it plans to publish during Fiscal...
USA – FDA official says pandemic reauthorization bill could drive VALID across finish line
A top US Food and Drug Administration (FDA) official said that a pandemic funding reauthorization bill could act as a vehicle for in vitro...
USA – FDA finalizes COVID-era guidance on container closure changes
The US Food and Drug Administration (FDA) has finalized a guidance to assist sponsors in reporting common changes made to glass vials and stoppers,...
USA – FDA drafts guidance on device production and quality system software assurance
The US Food and Drug Administration (FDA) has issued a draft guidance on software assurance for computer and data processing systems associated with medical...
USA – FDA updates guidance on remote regulatory assessments
The US Food and Drug Administration (FDA) has revised its draft guidance on remote regulatory assessments (RRAs), outlining how it plans to use both...
USA – Clinical Considerations for Studies of Devices Intended to Treat Opioid Use Disorder
The opioid epidemic is a serious and complex public health emergency facing the United States. The Agency has already taken significant steps to decrease...
USA – FDA releases draft guidance on use-related risk analysis for combo products
The US Food and Drug Administration (FDA) has released a draft guidance outlining the purpose and content of a use-related risk analysis (URRA) for...
USA – Use of International Standard ISO 10993-1, « Biological evaluation of medical devices –...
FDA has developed this guidance document to assist industry in preparing Premarket Applications (PMAs), Humanitarian Device Exceptions (HDEs), Investigational Device Applications (IDEs), Premarket Notifications...
USA – FDA authorizes marketing of first diagnostic test for detecting Zika virus antibodies
Today, the U.S. Food and Drug Administration authorized marketing of a diagnostic test to detect Zika virus immunoglobulin (IgM) antibodies in human blood. The ZIKV Detect...
