Learn about FDA medical device regulations and how to achieve approval. Our news and expert advice provides an overview of regulatory requirements for Class I, Class II, and Class III devices.

Latest Briefs & News

FDA has issued multiple emergency use authorizations, loosened regulations for telemedicine, and eased the requirements for production...

The U.S. Food and Drug Administration (FDA) has authorized the first diagnostic test with a home collection option for COVID-19. Specifically, the FDA re-issued the...

The U.S. Food and Drug Administration (FDA) has established new program specifically geared toward expediting the development of potentially safe and effective...

FDA has kicked off a new voluntary electronic submission program for 510(k)s.
Features: Test & Measurement
Your MDR Strategy: Start with a Gap Analysis
How to make sense of the 566-page Medical Device Regulation (MDR). This article focuses on a strategy to address material information and what should be included in a gap analysis.
Why Class I manufacturers should not place European Medical Device Regulation (EU MDR) compliance at the end of their to-do lists.

The U.S. Food and Drug Administration (FDA) has made policy changes to respond to the urgent need for even faster testing availability. Although laboratories could use the EUA...

The U.S. Food and Drug Administration (FDA) took action May 25, 2020, to make more ventilators available to healthcare personnel in the United States. FDA issued an emergency use...

The U.S. Food and Drug Administration took significant action to help increase the availability of ventilators and accessories, as well as other...

On Wednesday, March 25, 2020 (3–4 p.m. Eastern), the U.S. Food and Drug Administration (FDA) will host a virtual Town Hall for clinical laboratories and commercial...

The Food and Drug Administration (FDA) has issued a new guidance to provide a policy to help expand the availability and capability of noninvasive remote monitoring devices to facilitate...

The U.S. Food and Drug Administration (FDA) has taken two additional significant diagnostic actions during the coronavirus outbreak (COVID-19)...

FDA is postponing most foreign and domestic inspections through April, effective immediately. Inspections outside the U.S. deemed mission-critical will still be considered on a...

FDA says it is continuing to advance its scientific and technical capabilities, but a recent New York Times editorial says the agency is...

Medical device manufacturers have a big challenge in preparing for their regulatory device submissions for 2020. In addition to the European Union’s new Medical Device...

Medical device companies recognize that having an emphasis on design controls helps to assure good design and engineering practices that yield high-quality solutions. This is critical...

Under new rules to market medical devices in the European Union (EU), only 27 percent of respondents said they will be fully compliant with the...

As a first step toward implementation of its recently established Safety and Performance Based Pathway for medical devices, FDA is issuing draft guidances outlining the...

In 2018, an update on regulations for respiratory medical devices meant that volatile organic compounds (VOCs) emitted from the devices...

Gradient Valves

Clippard, Cincinnati, OH, has released gradient valves that feature multiple two-way, normally closed solenoids connected around a central body. The...

The test phase of FDA’s Software Precertification (Pre-Cert) Program has hit its halfway point. The agency has released an update on its progress and the...

Now that medical devices are being labeled and uniquely identified to meet the requirements of the U.S. Food and Drug Administration (FDA) Unique Device Identifier...

Orthopedic devices play a crucial role in providing pain relief, improving mobility, and enhancing the quality of life for patients suffering from musculoskeletal...

While the regulatory and validation burden can be high, it's not surprising that the medical device industry is one of the earliest adopters of additive manufacturing (AM, aka...

Companies regulated by the U.S. Food and Drug administration (FDA) need to establish current good manufacturing practices (CGMPs) as part of Title 21 CFR part 820 requirements. This...

In the spirit of promoting public transparency, the U.S. Food and Drug Administration’s Center for Devices and Radiological Health is taking a number of...

Ovarian cancer is usually diagnosed only after it has reached an advanced stage, with many tumors spread throughout the abdomen. Most patients undergo surgery to remove as many of...

Spurring Innovation of Brain-Computer Interface Devices FDA is continuing to encourage innovation in novel areas — the latest being novel brain implants, often...

The Luer connector is arguably one of the most important developments in the biomedical industry. Because it is reliable, simple to use, and economical to produce, the Luer connector...

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