Standards and Compliance

The U.S. Food and Drug Administration (FDA) has issued an updated guidance to explain...

Safety management programs are necessary to help a company make safe products and monitor safety for products in use. The CPSC has provided lots of guidances and mandates over the years on what constitutes an adequate program. These guidances are potentially useful to those companies seeking to establish a CPSC-compliant safety program and should be considered as part of the program development process.

The U.S. Food and Drug Administration (FDA) reports that it has granted more than...

The U.S. Senate has introduced a bipartisan measure that would help to ensure the...

The U.S. Food and Drug Administration (FDA) has issued an updated draft guidance that...

The Medical Device Coordination Group (MDCG) of the Commission of the European Union (EU)...

The U.S. Food and Drug Administration (FDA) has issued an alert to medical device...

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

Two leading medical industry groups in the European Union (EU) are calling on the...

The U.S. Food and Drug Administration (FDA) has requested public comment on its plan...