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

From the Editor : FDA/Regulatory
From the Editor — The Modern FDA: A New Pathway Gets Under Way

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 recommended premarket performance criteria and testing methodologies for four specific types of devices:

Features : Data Acquisition
Capturing Unique Device Identifier Data on Non-Sterile Orthopedic Implants
Capturing Unique Device Identifier Data on Non-Sterile Orthopedic Implants

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...

Capturing Unique Device Identifier Data on Non-Sterile Orthopedic Implants
Features : Wearables
Industrial CT is Hip: Quality of Life Enhanced with Additive Manufacturing
Industrial CT is Hip: Quality of Life Enhanced with Additive Manufacturing

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

Industrial CT is Hip: Quality of Life Enhanced with Additive Manufacturing
Briefs : Design
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
From the Editor : FDA/Regulatory
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 important steps to update its Medical Device Reporting (MDR) Program, says Dr. Jeffrey E. Shuren, MD, JD,...

Briefs : Imaging
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
From the Editor : FDA/Regulatory
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 : Medical
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 : Design
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
From the Editor : FDA/Regulatory
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 for getting these devices to market. In January, FDA issued its new Software Precertification (Pre-Cert)...

From the Editor : AR/AI
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 I’m encouraged by FDA’s recent announcement that it plans to modernize the 510(k) pathway. In...

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 : IoMT
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 : Test & Measurement
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
From the Editor : FDA/Regulatory
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 crisis.

INSIDER : FDA/Regulatory
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 : FDA/Regulatory
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 : Manufacturing & Prototyping
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 : 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...

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 : IoMT
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,...

Free Product Samples

FluoroPEELZ® – Peelable Heat Shrink

High-ratio FluoroPEELZ® helps overcome the difficulty of removing traditional heat shrink from the assembled device without damaging the shaft. Available in ratios up to 2:1, FluoroPEELZ® leaves a super-smooth surface when removed and saves inspection time and waste.

Request your free sample now! >>