FDA Requirements & Review

FDA Deploys Agentic AI to Modernize Regulatory Workflows

The FDA has taken a substantial step in its digital modernization strategy with the deployment of agentic AI capabilities across all agency employee groups. The move represents an expansion of the agency’s internal AI tools, intended to streamline complex, multi-step processes that support regulatory science, product review, and compliance activities. Read on to learn more.

From the Editor: FDA’s Big AI Moment Signals a New Era for Medtech

"If regulators are accelerating their digital transformation, the medtech community must be ready to meet them there." Read more about Editor and Director of Medical Content Sherrie Trigg's opinion in From the Editor.

Regulatory

In May 2004, FDA issued a guidance document that reclassified certain dental implants from Class III to Class II, thereby reducing regulatory burdens while maintaining safety standards. What type of dental implants were...

From the Editor - Bipartisan Legislation Could Fast-Track Breakthrough Medical Devices

The U.S. Senate's bipartisan legislation to expedite Medicare coverage of FDA-breakthrough-designated medical technologies and diagnostic tests could significantly impact the medical device industry and manufacturers, streamlining processes for breakthrough devices, enhancing patient access, and reducing barriers to market entry. Read on to see what Sherrie Trigg, Editor and Director of Medical Content, thinks about the matter.

From the Editor - FDA’s Final Rule on LDTs Raises Concerns for Personalized Medicine

Hear directly from Sherrie Trigg, Editor and Director of Medical Content, about the FDA's final ruling on LDTs and why that is raising concern.

Beware of FDA Multisite Inspections

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...

Regulatory

What government group was formed to study medical devices and recommend legislation, ultimately leading to the 1976 Medical Device Amendments?

Overcoming Challenges in Material Selection for 3D Printed Medical Devices

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...

From the Editor - FDA Releases Draft Guidance for Drug-Delivery Devices

At the end of June, FDA released a draft guidance that is designed to facilitate and streamline development of stand-alone devices and combination products by improving the consistency of drug-delivery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.

Medtech Theater: U.S. Food and Drug Administration to Adopt ISO 13485

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.

From the Editor - FDA's LDT Regulation Must Balance Safety and Innovation

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.

MasterControl Study: FDA, CPSC Recalls Up 115% Since 2018

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...

The Consultant, the FDA, and You

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.

FDA Establishes Advisory Committee on Digital Health Technologies

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...

FDA Awards Nearly $7.5 Million to Foster Pediatric Device Development

To foster the development and commercialization of medical devices designed for children, the Food and Drug Administration (FDA) has awarded a nearly $7.5 million grant to...

Paragonix Technologies Receives FDA Clearance for BAROguard Donor Lung Preservation System

Organ transplant developer, Paragonix Technologies has received FDA clearance for its next-generation donor lung preservation system, BAROguard™....

FDA Updates Catalog of Tools to Assess Medical Devices

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...

FDA Pilot Program Supports Streamlined Regulatory Submission Processes for Medical Device Manufacturers

The current U.S. regulatory framework for medical devices under the Center for Devices and Radiological Health (CDRH) includes extensive...

Movano Health to File First FDA Submission for Smart Ring’s SpO2 and Heart Rate Data

Movano Health, Pleasanton, CA, has announced successful preliminary results of its pivotal hypoxia trial, which was completed in conjunction with the...

Winter 2022 Resource Guide

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.

Summer 2022 Resource Guide

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.

First, Do No Harm: Changing Strategies to Prove Your Medical Device Is Safe

Modern evaluation of biocompatibility uses a risk-based approach.

Establishing Proper Validation of Extruded Silicone Tubing

Bring your project from the process development phase of manufacturing to a fully validated one.

From the Editor - Cybersecurity: Playbook for Threat Modeling Medical Devices

New best practices for understanding medical device security.

Winter 2021 Resource Guide

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.

The Three Challenges in Biomedical QC Testing

A robust, optimized mechanical testing program is essential to successful quality control testing.

Mastering the UKCA Compliance Challenge

Deadlines are approaching for compliance.

Summer 2021 Resource Guide

Our 2021 Resource Guide shows you the top manufacturers in materials, manufacturing, and a range of other medical-device categories.

Show Preview: Evolving to MedDev 2021

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.