FDA's quality system regulation (QSR) details specific activities that mustoccur for a new medical device to be made and commercialized in theUnited States. QSR ...

A new guidance document published by the US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) updates the agency's thinking on how to ensure that medical devices ...

The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...

The FDA released updated guidance on May 29, 2026, formalizing expectations for human factors information in medical device ...

As noted in Chapter 1, the committee was charged by the Food and Drug Administration (FDA) to review the 510(k) clearance process and answer two principal questions: Does the current 510(k) clearance ...

The US Food and Drug Administration (FDA), through its Center for Devices and Radiological Health (CDRH), regulates medical devices and radiation-emitting products. 1 The 510(k) clearance process, ...

Why is it necessary to develop human resources for developing medical devices? Muragaki: Medical devices tend to be over-imported, with data for 2021 showing a trade deficit of 1.8 trillion yen. In ...

The FDA recently issued draft guidances for the use of AI in medical devices, drugs, and biologics. The guidances emphasize the need for comprehensive AI policies addressing risk evaluation, data ...

This course acts as a primer—a basic introduction to medical devices and general aspects of product and regulatory lifecycles. Medical devices go through a long and complex process of development ...

The Food and Drug Administration designates as “breakthrough” technologies certain drugs and devices. This designation helps expedite the development and review of therapies intended to treat serious ...

Discover how software developers for medical-device OEMs are balancing innovation and safety, and the challenges they face in making it happen. The medical-device industry is rapidly advancing, from ...

Precision molded thermoplastic parts are used in everything from catheters and IVD cartridges to drug-delivery systems. In fact, the vast majority of medical devices include precision molded ...