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.

News : Medical
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.

From the Editor : Manufacturing & Prototyping
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 horizon.”

Features : Medical
Design Controls: Addressing Changes in ISO 13485

When ISO 9001 was produced by the International Standards Organization, it put forth the general quality standard that organizations could adopt to ensure that the organization is focused on quality, the basic structure is in place, and the product it is offering will be at acceptable levels. That...

Technology Leaders : Medical
Biocompatibility Evaluation of Breathing Medical Devices: Understanding ISO 18652
Biocompatibility Evaluation of Breathing Medical Devices: Understanding ISO 18652

Traditionally, toxicologists and biocompatibility experts considered the materials in breathing gas pathways as external communicating devices and evaluated...

Biocompatibility Evaluation of Breathing Medical Devices: Understanding ISO 18652
Features : FDA/Regulatory
Implementing IEC 62304 for Safe and Effective Medical Device Software, PART 2

The reliability of the embedded software used in medical devices and the risk associated with it has become a vital concern. IEC 62304, “Medical device software – Software life cycle processes,” has thus emerged as an internationally recognized mechanism for the...

Features : FDA/Regulatory
Implementing IEC 62304 for Safe and Effective Medical Device Software — PART 1
Implementing IEC 62304 for Safe and Effective Medical Device Software — PART 1

FDA’s introduction to its rules for medical device regulation states: “Medical devices are classified into Class I, II, and III. Regulatory control...

Implementing IEC 62304 for Safe and Effective Medical Device Software — PART 1
Features : IoMT
MAKING THINGS INTELLIGENT: The Advent of RFID in Medical Devices
MAKING THINGS INTELLIGENT: The Advent of RFID in Medical Devices

The Internet of Things (IoT) has been described as the interconnection via the Internet of computing devices embedded in everyday objects, enabling them to send and receive...

MAKING THINGS INTELLIGENT: The Advent of RFID in Medical Devices
Features : RF & Microwave Electronics
EMC Requirements: Pending Changes for the Fourth Edition of IEC 60601-1-2

Electromagnetic compatibility (EMC) requirements for medical devices and systems is defined by IEC 60601-1-2. The fourth edition implementation of this EMC standard is on the horizon and is a collateral standard to the IEC 60601-1 medical safety standard. It was issued by...

News : FDA/Regulatory
FDA Touts New AAMI Report on ‘Wireless Coexistence’ and Medical Devices

The Food and Drug Administration (FDA) is flagging a new technical information report (TIR) from AAMI that provides crucial guidance for “wireless coexistence” for a wide array of medical devices and systems.

News : FDA/Regulatory
FDA-Approved Algorithm Detects Hemorrhagic Shock

Researchers from the U.S. Army Institute of Surgical Research collaborated with scientists and engineers at the University of Colorado and Flashback Technologies, Inc., to develop an algorithm, the Compensatory Reserve Index (CRI), to detect when a patient experiences hemorrhagic shock, a leading...

Features : Manufacturing & Prototyping
Quality Assurance: Risk Mitigation for Lithium-Ion Battery Packs

Safety and reliability are the key concerns when determining the right power source for a medical device. Lithium-ion (Li-ion) batteries are often considered for their higher energy density, lighter weight, longer cycle life, superior capacity retention, and ability to withstand a...

Features : Medical
Design Validation and Regulatory Requirements
Design Validation and Regulatory Requirements

Design validation is one of the most important aspects of the design and development process for medical devices. It is at this stage that the medical device manufacturer confirms that the device...

Design Validation and Regulatory Requirements
Briefs : FDA/Regulatory
Cybersecurity Standards for Medical Devices

The U.S. Department of Veterans Affairs (VA) and UL (Underwriters Laboratories) announced a signed Cooperative Research and Development Agreement (CRADA) program to create medical device cybersecurity standards and certification approaches. CRADA was established as part of the Federal Technology...

Features : Test & Measurement
Solving the Compliance Puzzle for Medical Startup Companies: The Entrepreneur’s Basic Guide to Understanding Product Regulations & Testing

Often, the last thing first-time and even serial entrepreneurs think about is how the result of their passionate, innovative imagination is going to stand up to product testing and regulatory compliance...

Features : IoMT
The Internet of Things and UDI Compliance

Consider for a moment the modern automobile. A car’s computer can pinpoint for a mechanic exactly what’s going wrong, and provide a thorough history of how things have been working (or not) in recent weeks. Data networks keep tabs on recalls and alert drivers when parts need to be replaced. In some...

Features : Medical
New Medical Device EMC Requirements

Implementation of IEC 60601-1-2, 4th edition is on the horizon. This collateral standard to the IEC 60601-1 medical safety standard specifies the electromagnetic compatibility (EMC) requirements for medical devices and systems. The fourth edition was issued by the International Electrotechnical Commission...

News : Medical
UL and VA Sign CRADA for Medical Device Cybersecurity Standards

The U.S. Department of Veteran Affairs (VA), Washington, DC, and UL (Underwriters Laboratories), Northbrook, IL, a global safety science organization, have signed a Cooperative Research and Development Agreement (CRADA) for current and emerging medical devices cybersecurity...

News : Medical
Diabetes Technology Society Develops Cybersecurity Standard for Devices

The Diabetes Technology Society recently announced its new cybersecurity standard for interconnected diabetes devices called DTSec. The standard specifies performance requirements utilizing the ISO/IEC 15408 framework used to define security requirements on “smart”...

Features : Medical
Changes at FDA and New Publication Launch

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 Administration’s new Commissioner of Food and Drugs. As the top official of the FDA, he is committed to strengthening...

Features : Medical
Chemical Characterization Can Supplement and Support Biocompatibility Testing

Manufacturers producing medical devices that involve patient contact are typically required to perform biological safety evaluations, including biocompatibility tests to ensure patient safety, as specified by ISO 10993. Chemical characterization can help support the...

News : Medical
FDA Seeks Comments on Refurbishing of Medical Devices

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

News : FDA/Regulatory
Transition Planning for ISO 13485:2016

The International Organization for Standardization (ISO), Geneva, Switzerland, late last month released its long-awaited revision to ISO 13485, the global standard for medical device quality management systems (QMS), which was revised to respond to the latest developments in quality management, technology,...

Features : Medical
9 Tips for Addressing the Documentation Burden of the FDA’s Design Control Regulation

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 Administration (FDA) are related to design control.

News : Medical
New FDA Chief Confirmed by Senate

Dr. Robert M. Califf, a cardiologist, researcher, and founder of the Duke Clinical Research Institute, was confirmed by the Senate on February 24 as the next Commissioner of the U.S. Food and Administration by a wide margin. The Senate voted 89 to 4 in favor of placing Califf in the position, where he replaces...

Features : FDA/Regulatory
Selecting Power Supplies for Medical Equipment Designs

When it comes to medical equipment, nothing is more important than the safety of patients and health care personnel. From diagnostic tools such as ultrasound devices to home health equipment like dialysis machines, human safety is top priority. To ensure that devices and equipment are not...

News : Medical
FDA Recommends Cybersecurity Measures for Device Manufacturers

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 issued a draftguidance outlining important steps medical device manufacturers should take to continually...

News : FDA/Regulatory
FDA Proposes Early Warning for Device Safety Failures

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 analyzing, and for which the agency does not yet have specific recommendations" of possible device risk.

News : FDA/Regulatory
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...

News : Electronics & Computers
IEEE Advances Standards and Works to Expand Interoperable eHealth Communications

IEEE, Piscataway, NJ, has announced a new standard and two new standards development projects designed to support plug-and-play, interoperable communications across eHealth devices. The new eHealth standard is IEEE 2410™-2015, Biometrics Open Protocol Standard,...

News : 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...

Free Product Samples

New Polyimide Products from Zeus

Zeus is now able to fill your polyimide (PI) needs with the introduction of our new polyimide and PI Glide™ tubing and coated wire capabilities. Our polyimide tubing and coated wire is available in the smallest dimensions and in a high lubricity form, PI Glide™.

Request your free sample now! >>