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: Most Medical Device OEMs Not Ready to Comply with 2020 EU Regulation

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 regulations...

From the Editor : Medical
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:

Briefs : FDA/Regulatory
A Fast, Simple Sampling Method for Characterizing Volatile Organic Compounds Emitted from Medical Devices

In 2018, an update on regulations for respiratory medical devices meant that volatile organic compounds (VOCs) emitted from the devices...

Products : Mechanical & Fluid Systems
Medical Design Briefs Product Focus (September 2019): Pumps/Valves

Gradient Valves

Clippard, Cincinnati, OH, has released gradient valves that feature multiple two-way, normally closed solenoids connected around a central body. The...

From the Editor : Software
From the Editor — Digital Health: Lessons Learned So Far from FDA’s Test Phase

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...

Features : Medical
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...

Features : Manufacturing & Prototyping
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...

Briefs : Software
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...

Features : Medical
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...

From the Editor : Medical
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 : FDA/Regulatory
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...

From the Editor : Medical
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...

Features : Connectivity
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...

News : Electronics & Computers
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...

Features : Design
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...

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 : Test & Measurement
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...

Features : Medical
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,...

News : FDA/Regulatory
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....

Features : Packaging & Sterilization
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,...

From the Editor : Manufacturing & Prototyping
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 : Medical
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...

News : Medical
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...

Briefs : Test & Measurement
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....

Features : Packaging & Sterilization
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...

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3D Printed Metals Are Not All the Same

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Testing and Inspecting 3D-Printed Parts

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Using Simulation to Design Robust Adhesively Bonded Structures

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Electric-Vehicle Transmission Development and Simulation

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Thermal Management Crisis: Knowing Your Passive Solution Options

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IoT’s Role in Today’s Transportation Systems

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