Design & Testing

FDA/​Regulatory

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

News : 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...

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....

News : 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...

News : FDA/Regulatory
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...

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...

Features : FDA/Regulatory
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...

News : 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...

Features : Design
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...

News : Connectivity
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 : IoMT
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 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...

Features : Medical
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 : Connectivity
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...

News : FDA/Regulatory
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...

News : FDA/Regulatory
FDA Announces First Patient Engagement Advisory Committee

While historically, the development of new technologies to improve patients’ lives has relied upon experts’ opinions rather than asking patients and families directly what they consider important, this may be about to change. Patients and their care partners are becoming intimately...

Briefs : FDA/Regulatory
Smooth Compliance: Considerations for UDI Labeling Initiatives

In September 2013, the FDA announced new regulations for medical device manufacturers known as UDI (Unique Device Identifier) that would require all medical devices to bear a label containing specific information by the year 2020. The regulations were designed to phase in over a...

News : FDA/Regulatory
FDA Revises Fees for Medical Device Export Certificates

The Emergo Group recently posted an advisory that the FDA has revised the fee charged for issuing medical device export certificates in response to higher costs and demand for these documents.

Features : IoMT
Standard Security Framework for Medical Device Technologies: A Work in Progress

Collaboration among healthcare technology stakeholders—from device manufacturers and healthcare delivery organizations to healthcare security intelligence organizations—is needed to integrate medical and IT security requirements and develop a standard security...

Briefs : FDA/Regulatory
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...

Features : FDA/Regulatory
A “Particle” of Prevention Is Worth a Pound of Cure: The Significant Benefits of Premarket and Postmarket Particulate Testing of Cardiovascular Devices

Particulate testing of cardiovascular medical devices is an important and valuable step on the road to regulatory clearance, market success, and patient safety. Device manufacturers that...

News : Medical
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...

Features : Medical
Do or Demise: Why It’s Crucial for Medical Device Manufacturers to Adhere to the FDA’s ABCs

Medical device manufacturers frequently face unique industry challenges, including the need to manage quality processes across disparate sites or business units and increased legal and regulatory scrutiny. The FDA requires that each medical device...

Features : FDA/Regulatory
Safety, Compliance, and Regulation: The Gateway for Laser-Based Products into the Marketplace

Many medical devices, both existing and new designs, are laser-based. For some time, lasers have been designed into medical devices from diagnostic, imaging, and therapeutic systems, to invasive treatment designs like those for cauterization, surgical...

News : FDA/Regulatory
FDA Issues Small Entity Compliance Guidance for UDI

On August 13, The FDA issued a guidance for industry and FDA staff called “Unique Device Identification System: Small Entity Compliance Guide”. This guidance is intended primarily to provide information to the medical device industry, including small businesses, concerning FDA’s...

News : Medical
New Proposed ASTM Standard

ASTM International, formerly known as the American Society for Testing and Materials (ASTM), West Conshohocken, PA, has proposed a new international standard to be used in the design, development, quality control, and comparison of a variety of collagen-based medical products, including surgical implants, delivery...

News : Medical
FDA Finalizes Rule on UDI

Today, the FDA issued its final rule on the unique device identification (UDI) system that, once implemented, will provide a consistent way to identify medical devices. The UDI system should improve the quality of information in medical device adverse events reports, which will help the FDA identify product problems...

News : Communications
FDA Issues Guidance on Wireless Technology in Medical Devices

The FDA Center for Devices and Radiological Health, Office of Science and Engineering Laboratories, Center for Biologics Evaluation and Research issued a Guidance document on “Radio Frequency Wireless Technology in Medical Devices” containing recommendations to assist industry and...

News : Communications
FDA Issues Guidance on Wireless Technology in Medical Devices

The FDA Center for Devices and Radiological Health, Office of Science and Engineering Laboratories, Center for Biologics Evaluation and Research issued a Guidance document on “Radio Frequency Wireless Technology in Medical Devices” containing recommendations to assist industry and...

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