FDA/​Regulatory

Regulatory & Guidance Documents

Medical Device regulatory documents can help you understand requirements for the software and instruments used in the healthcare field. Find guidance as you develop your medical devices.

Briefs: Manufacturing & Prototyping
Deadlines are approaching for compliance.
Supplements: AR/AI
Our 2021 Resource Guide shows you the top manufacturers in materials, manufacturing, and a range of other medical-device categories.
From the Editor: FDA/Regulatory
FDA has created a “Catalog of Regulatory Science Tools,” in which it provides a comprehensive list of peer-reviewed resources for medical device developers.
Features: FDA/Regulatory
The "Evolving To MedDev" 2021 digital event will provide automotive and aerospace companies with practical information about how they can enter into the medical device supply chain.
Features: FDA/Regulatory
While many devices have received Emergency Use Authorization (EUA) for short-term use, new testing procedures are needed for the long-term.
Technology Leaders: Robotics, Automation & Control
There are no true "medical robots," says an industry expert. Here's why.
Briefs: Medical
Regulatory changes have allowed these essential healthcare professionals to step in and help out more independently.
From the Editor: FDA/Regulatory
FDA just released the agency’s first action plan addressing artificial intelligence (AI) and machine learning (ML).
Blog: FDA/Regulatory

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
A number of manufacturers are still in the process of confirming who qualifies as an "Economic Operator."
Features: FDA/Regulatory
Philip Nelson, a partner with Knobbe Martens, provides some insights for device companies facing challenges with intellectual property.
Features: Test & Measurement
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.
Features: Medical
Why Class I manufacturers should not place European Medical Device Regulation (EU MDR) compliance at the end of their to-do lists.
Blog: Medical

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...

Blog: FDA/Regulatory

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

Blog: FDA/Regulatory

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...

Blog: FDA/Regulatory

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...

Blog: Medical

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

From the Editor: Medical

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...

Features: FDA/Regulatory

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...

From the Editor: FDA/Regulatory

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

Briefs: Test & Measurement

Calibration of a device is carried out to minimize the uncertainty in measurements. It helps in reducing the errors and brings the measurement to an acceptable level....

News: Medical

By the time you read this, Robert M. Califf, MD, a recognized global leader in cardiology, clinical research, and medical economics, will have been installed as the U.S. Food and Drug...

INSIDER: FDA/Regulatory

The FDA is seeking comments from the medical device industry and healthcare community that refurbish, recondition, rebuild, remarket, remanufacture, service, and repair medical...

Features: Medical

Some of the biggest stumbling blocks encountered by medical device firms on the way to clearance or approval of their devices by the U.S. Food and Drug...

INSIDER: FDA/Regulatory

Cybersecurity threats to medical devices are a growing concern that present a potential risk to the safety and effectiveness of medical devices. To address this, the FDA has...

INSIDER: Medical

In a draft guidance for industry and staff issued on December 31, the FDA proposed notifying the public about medical device “emerging signals that the agency is monitoring or...

INSIDER: Medical
FDA Announces Training Program for Medtech Reviewers

The FDA’s Center for Devices and Radiological Health (CDRH) announced the 2015 Experiential Learning Program (ELP) General Training Program, which is intended to educate CDRH staff regarding the policies, laboratory practices, and challenges faced in broader disciplines that impact the...

INSIDER: Medical
FDA Issues Draft Guidance for Animal Studies for Medical Devices

On October 14, the FDA issued a draft guidance document to assist industry in designing evaluation strategies for, and reporting the results of, animal studies for medical devices. The studies utilized for the assessment of these devices typically provide initial evidence of device...

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