Standards by Topic

As part of its effort to evaluate its precertification framework for software with medical...

The U.S. Food and Drug Administration (FDA) has issued a guidance that addresses comparable...

The U.S. Food and Drug Administration (FDA) has issued a new guidance intended to...

The Center for Devices and Radiological Health (CDRH) of the U.S. Food and Drug...

The U.S. Food and Drug Administration (FDA) has issued a final guidance clarifying the...

Despite the month-long partial shut-down of the U.S. federal government, the Food and Drug...

The European Commission's Low Voltage Directory (LVD) legal obligations vary for economic operators, with most falling upon manufacturers. The new LVD Guide offers interpretation and instruction on these obligations, clarifying when importers and distributors might take on manufacturer responsibilities among other issues.

This article provides information on the changes found in Amendment 1 to the 6th Edition of UN 38.3, which details recommended testing to assess potential hazards associated with lithium-ion batteries in transit.

The U.S. Food and Drug Administration (FDA) has issued a proposed rule intended to...

The U.S. Food and Drug Administration (FDA) has issued a final guidance intended to...