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

Briefs : Medical
Advanced Design Tools for Additively Manufactured Medical Devices
Advanced Design Tools for Additively Manufactured Medical Devices

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...

Advanced Design Tools for Additively Manufactured Medical Devices
Features : FDA/Regulatory
Why Cloud QMS Better Supports Regulatory Compliance
Why Cloud QMS Better Supports Regulatory Compliance

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...

Why Cloud QMS Better Supports Regulatory Compliance
News : Medical
From the Editor — FDA Moves to Increase Transparency of Medical Device Reporting
From the Editor — FDA Moves to Increase Transparency of Medical Device Reporting

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...

From the Editor — FDA Moves to Increase Transparency of Medical Device Reporting
Briefs : Robotics, Automation & Control
Imaging System Helps Surgeons Remove Tiny Ovarian Tumors
Imaging System Helps Surgeons Remove Tiny Ovarian Tumors

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...

Imaging System Helps Surgeons Remove Tiny Ovarian Tumors
News : Medical
From the Editor — Spurring Innovation of Brain-Computer Interface Devices
From the Editor — Spurring Innovation of Brain-Computer Interface Devices

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

From the Editor — Spurring Innovation of Brain-Computer Interface Devices
Features : Test & Measurement
Luer Connectors: Testing to the New International Standard
Luer Connectors: Testing to the New International Standard

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...

Luer Connectors: Testing to the New International Standard
News : Electronics & Computers
FDA: Cybersecurity Vulnerabilities Affecting Medtronic's ICDs, Programmers, Home Monitors
FDA: Cybersecurity Vulnerabilities Affecting Medtronic's ICDs, Programmers, Home Monitors

The U.S. Food and Drug Administration (FDA) issued a safety communication to alert healthcare providers and patients about cybersecurity...

FDA: Cybersecurity Vulnerabilities Affecting Medtronic's ICDs, Programmers, Home Monitors
Features : Connectivity
Electrical Connectors: Design Considerations for Medical Devices
Electrical Connectors: Design Considerations for Medical Devices

The myriad of devices used in surgical, interventional, imaging, diagnostic and therapeutic, sensors, and single-use medical applications use some form of transmission medium...

Electrical Connectors: Design Considerations for Medical Devices
News : Medical
From the Editor — Reimagining Digital Health Devices: FDA’s New Precertification Model
From the Editor — Reimagining Digital Health Devices: FDA’s New Precertification Model

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

From the Editor — Reimagining Digital Health Devices: FDA’s New Precertification Model
News : AR/AI
From the Editor — Giving the 510(k) Pathway a Much-Needed Makeover
From the Editor — Giving the 510(k) Pathway a Much-Needed Makeover

Making changes to a regulatory process is usually difficult, slow, and often painful — after all, it involves lots of bureaucracy and many “cooks in the kitchen.” But...

From the Editor — Giving the 510(k) Pathway a Much-Needed Makeover
News : Medical
Instron’s Calibration Laboratory Goes Global
Instron’s Calibration Laboratory Goes Global

As of September 2018, Instron’s Calibration Laboratory in Norwood, MA USA (NVLAP Lab Code 200301-0) expanded its global reach to include Europe into its existing operations. This addition...

Instron’s Calibration Laboratory Goes Global
Features : Medical
Power Architectures for Patient-Connected Medical Devices
Power Architectures for Patient-Connected Medical Devices

Meeting the requirements for patient-connected medical devices can present challenges for power system designers. There are several key elements to consider, including isolation,...

Power Architectures for Patient-Connected Medical Devices
News : FDA/Regulatory
FDA to Address New “Quik” Review Program Pilot for Faster Review of Certain 510(k)s
FDA to Address New “Quik” Review Program Pilot for Faster Review of Certain 510(k)s

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....

FDA to Address New “Quik” Review Program Pilot for Faster Review of Certain 510(k)s
Features : Medical
Reusable Medical Devices: BI Selection, Overkill Validation Approaches, and First-Time Validation Pass Rates in Common Healthcare Steam Sterilization Cycles
Reusable Medical Devices: BI Selection, Overkill Validation Approaches, and First-Time Validation Pass Rates in Common Healthcare Steam Sterilization Cycles

When validating the steam sterilization instructions for a reusable medical device,...

Reusable Medical Devices: BI Selection, Overkill Validation Approaches, and First-Time Validation Pass Rates in Common Healthcare Steam Sterilization Cycles
News : Manufacturing & Prototyping
From the Editor — Can Your Medical Device Help Solve the Opioid Crisis? Tell FDA
From the Editor — Can Your Medical Device Help Solve the Opioid Crisis? Tell FDA

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

From the Editor — Can Your Medical Device Help Solve the Opioid Crisis? Tell FDA
INSIDER : Medical
NIST Grant to Develop Standards for Biomaterial Manufacturing
NIST Grant to Develop Standards for Biomaterial Manufacturing

A grant from the National Institute of Standards and Technology (NIST) will be used to to develop standards for regenerative medicine and biomaterial manufacturing. NIST awarded a...

NIST Grant to Develop Standards for Biomaterial Manufacturing
News : Medical
FDA Sets 2019 Medical Device User-Fee Rates
FDA Sets 2019 Medical Device User-Fee Rates

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...

FDA Sets 2019 Medical Device User-Fee Rates
Briefs : Test & Measurement
Guide to FDA Requirements and Importance of Medical Device Calibration
Guide to FDA Requirements and Importance of Medical Device Calibration

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....

Guide to FDA Requirements and Importance of Medical Device Calibration
Features : FDA/Regulatory
Disposables Lead the Way to Fighting HAIs, Preventing Errors
Disposables Lead the Way to Fighting HAIs, Preventing Errors

A key driver of the medical disposables market is the desire to minimize the risk of healthcare-associated infections (HAIs). Healthcare providers are turning to disposable...

Disposables Lead the Way to Fighting HAIs, Preventing Errors
News : Medical
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...

News : Test & Measurement
Medical Device Preclinical Bootcamp to Explore Testing Pathway

An upcoming seminar will explore the preclinical testing pathway for medical devices. The event will cover everything from concept to regulatory submission, including relevant regulations and standards, as well as the role each type of test plays in the overall testing program. It...

Features : Imaging
Software: Improving Risk Management in Medical Device Manufacturing
Software: Improving Risk Management in Medical Device Manufacturing

In an industry where people's health and wellness are on the line, manufacturers can't afford to let risk go unaddressed. As the International Organization for...

Software: Improving Risk Management in Medical Device Manufacturing
News : Medical
New Exoskeletons and Exosuits Standards Group Outlines First Steps

ASTM International’s new committee on exoskeletons and exosuits (F48) held its first meeting Feb. 13–14 in Philadelphia, PA, near the organization’s global headquarters. The need for technical standards has grown alongside the rising use of exoskeletons in manufacturing,...

News : Test & Measurement
Biocompatibility Expert to Discuss Successful Sample Preparation for Medical Device Testing

Properly prepared test articles are critical for accurate biocompatibility testing. As a sponsor of a medical device, it is imperative for medical device manufacturers to understand what to do to ensure a successful test of a proposed medical device.

News : Medical
From the Editor – FDA Ushers in a New Era of 3D Printing and Additive Manufacturing
From the Editor – FDA Ushers in a New Era of 3D Printing and Additive Manufacturing

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

From the Editor – FDA Ushers in a New Era of 3D Printing and Additive Manufacturing
News : Medical
From the Editor – FDA Ushers in a New Era of 3D Printing and Additive Manufacturing
From the Editor – FDA Ushers in a New Era of 3D Printing and Additive Manufacturing

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

From the Editor – FDA Ushers in a New Era of 3D Printing and Additive Manufacturing

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The Future of Modeling is Here

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Freeform Optics Design for Illumination Applications

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Infrared Imaging Technology

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Cooling Strategies for High-Power Electronics Cabinets

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Online Design Tools for Thermal Applications