FDA/​Regulatory

FDA Requirements & Review

Explore Medical Device FDA guidelines and requirements for labeling, training, distributing, tracking, and reporting.

Latest Briefs & News

Magnetic angle sensors, heat-staking platforms, regulatory software, and more.
When the Emergency Use Authorization Act is lifted, the FDA will have a real device review in place, says our guest editor.
To produce an additively manufactured prosthesis, REJOINT starts by 3D modelling the patient’s CT scan.

As summer 2020 gives way to fall and we continue grappling with unprecedented challenges, healthcare industry efforts persist to ensure that medical supplies are available when and where they are...

Yes, there will be a day when the U.S. EUA, Emergency Use Authorization Act, will be lifted, the medical device industry goes back to reality, and the FDA regains control of the medical approval process...

Features: FDA/Regulatory
Q&A: How Do You Protect Your IP?
Philip Nelson, a partner with Knobbe Martens, provides some insights for device companies facing challenges with intellectual property.

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 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.

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...

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 in...

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...

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...

When digital devices and technologies became the rule rather than the exception, FDA had to rethink its regulatory framework and evaluation process...

On October 10, 2018, FDA will host a webinar to share information and answer questions about the Quality in 510(k) (“Quik”) Review Program pilot....

Earlier this year, FDA sent a challenge to the medical device industry: develop devices and diagnostics to help combat, prevent, and treat the opioid...

The Food and Drug Administration (FDA) has announced the fee rates and payment procedures for medical device user fees for fiscal year (FY) 2019. The Federal Food, Drug, and Cosmetic Act (FD&C...

News: FDA/Regulatory
FDA Launches Innovation Challenge for Devices to Prevent and Treat Opioid Use

FDA has launched an innovation challenge to spur the development of medical devices, including digital health and diagnostic devices, to help combat the opioid crisis and to help prevent and treat Opioid Use Disorder — a serious health condition that can be a...

FDA is monitoring the emerging field of 3D printing and additive manufacturing, an area FDA once considered a “futuristic technology on the distant...

News: Connectivity
FDA Touts New AAMI Report on ‘Wireless Coexistence’ and Medical Devices

The Food and Drug Administration (FDA) is flagging a new technical information report (TIR) from AAMI that provides crucial guidance for “wireless coexistence” for a wide array of medical devices and systems.

R&D: Medical
FDA-Approved Algorithm Detects Hemorrhagic Shock

Researchers from the U.S. Army Institute of Surgical Research collaborated with scientists and engineers at the University of Colorado and Flashback Technologies, Inc., to develop an algorithm, the Compensatory Reserve Index (CRI), to detect when a patient experiences hemorrhagic shock, a leading...

Design validation is one of the most important aspects of the design and development process for medical devices. It is at this stage that the medical device manufacturer confirms that the device...

Dr. Robert M. Califf, a cardiologist, researcher, and founder of the Duke Clinical Research Institute, was confirmed by the Senate on February 24 as the next Commissioner of the U.S. Food and...

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