Get our free email newsletter

medical devices

FDA Issues Guidance on Recognition of Voluntary Consensus Standards

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

FDA Clarifies Registration, Listing Requirements for Medical Device Manufacturing Facilities During Pandemic

The U.S. Food and Drug Administration (FDA) has provided updated clarification on its requirements...

EU Commission Issues Regulation Regarding Single-Use Medical Devices

The Commission of the European Union (EU) has issued common specifications for the reprocessing...

FDA Issues Initial Guidance on Medical Device Regulatory Submissions in Electronic Format

The U.S. Food and Drug Administration (FDA) has issued initial guidance on its general...

EU Commission Releases Report on Notified Body Response to Medical Device Conformity Assessments During Pandemic

The Commission of the European Union (EU) has published the results of its survey...
- From Our Sponsors -

U.S. FDA Issued Guidance on Enforcement of Non-Invasive Remote Monitoring Devices

As the impact of the COVID-19 pandemic continues to challenge the nation’s healthcare system,...

U.S. FCC Grants Healthcare Waiver to Expedite Medical Equipment

In the midst of the COVID-19 pandemic, the U.S. Federal Communications Commission (FCC) has...

EUs MDR Date of Application Delayed Until 2021

In a major development for medical device manufacturers, the Parliament and Council of the European...

U.S. FDA Temporarily Eases Enforcement Policies for Certain Digital Health Devices

Moving quickly to address the need for advanced medical technologies during the COVID-19 outbreak...

U.S. FDA Allows Expanded Use of Medical Devices for Remote Patient Monitoring

In an action to support the healthcare system care for patients during the COVID-19...
- From Our Sponsors -

Digital Sponsors

Become a Sponsor

Discover new products, review technical whitepapers, read the latest compliance news, and check out trending engineering news.

Get our email updates

What's New

- From Our Sponsors -

Sign up for the In Compliance Email Newsletter

Discover new products, review technical whitepapers, read the latest compliance news, and trending engineering news.