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.

Latest Briefs & News

FDA just released the agency’s first action plan addressing artificial intelligence (AI) and machine learning (ML).

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...

A number of manufacturers are still in the process of confirming who qualifies as an "Economic Operator."
Philip Nelson, a partner with Knobbe Martens, provides some insights for device companies facing challenges with intellectual property.
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) 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)...

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...

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...

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

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....

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...

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

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...

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: FDA/Regulatory
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...

INSIDER: FDA/Regulatory
FDA Releases Cache of Medical Device Data

OpenFDA is releasing a treasure trove of information on medical devices that could help spur innovation and advance scientific research. OpenFDA’s Application Programming Interface (API) expands the previous resources about medical device-related adverse events and recalls by incorporating information...

INSIDER: Medical
FDA Piloting Program for Quarterly Device Malfunction Reporting

The FDA is seeking companies to take part in a pilot program that would allow medical device manufacturers to report malfunctions of certain low- and medium-risk devices on a quarterly basis. This pilot program will help the agency develop criteria for quarterly malfunction...

Briefs: Medical
FDA Draft Guidance for Adaptive Designs

The FDA is seeking comments of a new draft guidance that it recently issued for industry called “Adaptive Designs for Medical Device Clinical Studies.” An “adaptive design” for a medical device clinical study is defined as a clinical trial design that allows for prospectively planned modifications...

INSIDER: Medical
FDA Withdraws 47 Draft Guidance Documents

The U.S. Food and Drug Administration has withdrawn 47 draft guidance documents published before December 31, 2013, which were never finalized or acted on. The announcement was posted in the Federal Register, stating that this move was made to improve the efficiency and transparency of the guidance...

The FDA recently adopted three nanotechnology standards as part of a major update to the administration’s List of Recognized Standards. The documents comprise a Technical Specification (TS)...

INSIDER: Medical
FDA Amends Reporting Rules to Align with UDI Program

Medical device regulators at the FDA have issued correcting amendments to their post-market electronic Medical Device Reporting (eMDR) requirements to eliminate any disparities between those rules and their Unique Device Identification (UDI) system.

News: FDA/Regulatory
Health Canada to Require CMDR Compliance for Single-Use Devices

Health Canada, the Canadian medical device market regulator, is set to require all reprocessed single-use medical devices to Canadian Medical Device Regulations (CMDR) by September 1, 2015. According to MEDEC, the national association created for the Canadian medical technology...

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John Chandler on Achieving Quality Motion Control

FAULHABER MICROMO brings together the highest quality motion technologies and value-added services, together with global engineering, sourcing, and manufacturing, to deliver top quality micro motion solutions. With 34 years’ experience, John Chandler injects a key engineering perspective into all new projects and enjoys working closely with OEM customers to bring exciting new technologies to market.

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