Regulations/​Standards

FDA Compliance/​Regulatory Affairs

Stories

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Blog: Regulations/Standards
Recently, I came across an FDA regulatory situation you do not see too often. On the same day, FDA sent two teams of field investigators into two geographically different sites of the same company to...
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Trivia: Medical
What government group was formed to study medical devices and recommend legislation, ultimately leading to the 1976 Medical Device Amendments?
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Podcasts: Regulations/Standards
In this season, we are taking an in-depth look at Printed Health: Transforming Medicine with Advanced Manufacturing, and this episode will focus specifically on...
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From the Editor: Regulations/Standards
At the end of June, FDA released a draft guidance that is designed to facilitate and streamline development of stand-alone devices and combination products by improving the consistency of drug-delivery performance information included in applications and submissions. Read on to learn more about it.
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INSIDER: Regulations/Standards
On Tuesday, February 6 at 12:30 pm, Balazs Boznik, BSEE, Technical Director, Medical Audit, at SGS North America will discuss FDA’s plan to adopt ISO 13485.
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From the Editor: Regulations/Standards
Analytics firm GlobalData has weighed in on the U.S. FDA's proposal to reclassify laboratory-developed tests (LDTs) as medical devices. FDA historically exercised enforcement discretion over LDTs, meaning that it did not actively regulate them like it does for other medical devices, so this is a significant regulatory change.
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News: Regulations/Standards
MasterControl, a provider of quality and manufacturing software solutions for the life sciences industry, has released a new study analyzing five years of product recall data from...
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Blog: Medical
Understanding what the FDA really means by their time frames, knowing how to address their regulatory issues, and preparing a response to a 483 or Warning Letter is critical to showing the FDA that you understand what they expect from you and that you will work to bring your company into compliance. Another critical point is to understand that you can negotiate with the agency.
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News: Regulations/Standards
The U.S. Food and Drug Administration has created a new Digital Health Advisory Committee to help the agency explore the complex, scientific and technical issues related to...
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Briefs: Regulations/Standards
The EPA issued two separate proposals earlier this year covering the use of EtO for device sterilization: the National Emission Standards for Hazardous Air Pollutants and the preliminary interim decision under the Federal Insecticide, Fungicide, and Rodenticide Act.
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News: Regulations/Standards
The U.S. Food and Drug Administration (FDA) updated its Catalog of Regulatory Science Tools by adding four new tools and updating nine others. The catalog is a peer-reviewed resource...
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Supplements: Manufacturing & Prototyping
In our summer edition of the MDB Resource Guide, learn about new cleaning requirements and find the right company to match your medical-design needs.
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News: Medical
The current U.S. regulatory framework for medical devices under the Center for Devices and Radiological Health (CDRH) includes extensive...
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Features: Regulations/Standards
The Institute for Engineering in Medicine’s Innovation Week highlights events that focus on advances and new directions in medical engineering.
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News: Wearables
Movano Health, Pleasanton, CA, has announced successful preliminary results of its pivotal hypoxia trial, which was completed in conjunction with the...
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Supplements: Connectivity
In our summer edition of the MDB Resource Guide, learn about new cleaning requirements and find the right company to match your medical-design needs.
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Features: Medical
Medical device manufacturers face constant changes coming from both internal and external sources.
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Supplements: Packaging & Sterilization
In our summer edition of the MDB Resource Guide, learn about new cleaning requirements and find the right company to match your medical-design needs.
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Features: Mechanical & Fluid Systems
Although the pandemic has delayed the MDR’s validation date, it has not diminished the importance of this new regulation.
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Technology Leaders: Regulations/Standards
Modern evaluation of biocompatibility uses a risk-based approach.
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Features: Regulations/Standards
Bring your project from the process development phase of manufacturing to a fully validated one.
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From the Editor: Regulations/Standards
New best practices for understanding medical device security.
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Supplements: Connectivity
In our winter edition of the MDB Resource Guide, learn about new cleaning requirements and find the right company to match your medical-design needs.
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Features: Software
A robust, optimized mechanical testing program is essential to successful quality control testing.
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Briefs: Regulations/Standards
Deadlines are approaching for compliance.
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Features: Regulations/Standards
Rodd Turnquist tells Medical Design Briefs how to select the best pumps for medical devices and accelerating time to market.
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Supplements: Materials
Our 2021 Resource Guide shows you the top manufacturers in materials, manufacturing, and a range of other medical-device categories.
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From the Editor: Regulations/Standards
FDA has created a “Catalog of Regulatory Science Tools,” in which it provides a comprehensive list of peer-reviewed resources for medical device developers.
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Features: Manufacturing & Prototyping
The "Evolving To MedDev" 2021 digital event will provide automotive and aerospace companies with practical information about how they can enter into the medical device supply chain.
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Ask the Expert

Ralph Bright on the Power of Power Cords
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Understanding power system components and how to connect them correctly is critical to meeting regulatory requirements and designing successful electrical products for worldwide markets. Interpower’s Ralph Bright defines these requirements and explains how to know which cord to select for your application.

Inside Story

Inside Story: Establishing Safe EO Sterilization for Medical Devices
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To find out more about the expertise required to establish a safe and effective EO Sterilization for medical devices, MDB recently spoke with Elizabeth Sydnor, director of microbiology for Eurofins Medical Device Testing (Lancaster, PA).

Videos