Standards and Compliance

The U.S. Food and Drug Administration (FDA) has released a discussion paper on specific...

The U.S. Food and Drug Administration (FDA) has extended the public comment period on...

This article will discuss the basic kinds of defects that can be alleged in any product liability case, the law as it pertains to compliance with standards, and some tips on how to deal with the issue of standards compliance.

The U.S. Food and Drug Administration (FDA) has published a Final Guidance on the...

The U.S. Food and Drug Administration (FDA) has released a draft guidance detailing the...

This article describes the activities of the C63 Committee on EMC over the last two years. It summarizes how the Committee has been remotely meeting and reports on the progress the Committee has made on its active EMC standards.

This article discusses the legislation that applies when placing radio equipment on the Saudi market. For product manufacturers intent on exporting radio equipment to Saudi Arabia, the fact that the relevant legislation was adopted at the national level is significant. The article gives an overview of the Saudi legal framework, including obligations falling upon radio equipment manufacturers and importers.

The European Union’s (EU’s) new regulation for medical devices sold or imported into the...

The U.S. Food and Drug Administration (FDA) has published its most recent data on...

This article discusses techniques for assessing the effectiveness of existing shielding and penetration protection in power substations against early-time, high-altitude electromagnetic pulse (E1 HEMP) and intentional electromagnetic interference (IEMI).