Regulatory & Guidance Documents

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.

Product of the Month

See the product of the month: SGS has received EPA approval as a recognized third-party certification body for testing and certification of magnetic resonance imaging (MRI) machines under the ENERGY STAR® label. The certification allows brands and manufacturers to demonstrate that a device uses less energy in ready to scan mode as well as via an automated power down to an energy saving low power state. Read on to learn more.

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...

Children’s National, FDA Collaborate to Advance Pediatric Device Regulatory Tools

In a significant collaboration to help advance pediatric health, Children’s National Hospital and the U.S. Food and Drug Administration’s (FDA) Office of...

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.

From the Editor - FDA Releases Draft Guidance for Drug-Delivery Devices

At the end of June, FDA released a draft guidance that is designed to facilitate and streamline development of stand-alone devices and combination products by improving the consistency of drug-delivery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

The Politics of Health: How Global Elections Will Impact on Life Sciences

The global landscape for medical technology, biotechnology, and life sciences is on the cusp of seismic change.

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.

MDR: Regulating Devices That Don’t Have an Intended Medical Purpose

Neither the MDR nor Annex XVI are new. Nevertheless, the entry into force of the common specifications now presents a new situation for manufacturers of devices without an intended medical purpose.

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 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...

TÜV SÜD Receives UKAB for Medical Devices

TÜV SÜD has received approval as a UK Approved Body (UKAB) for medical devices. With this approval, medical device manufacturers can implement UKCA certification for the UK market and CE...

Artificial Intelligence: Making Innovations Fit for the MDR

Thanks to artificial intelligence (AI), augmented reality (AR) has long shaped product development across a variety of areas, including the medtech industry.

Windsor Agreement: Changes to Northern Ireland Regulatory Landscape

An agreement reached by the UK and EU regarding the Windsor Framework brings changes to the Northern Ireland regulatory landscape. The agreement , in principle, was reached on...

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...

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.

Exploring Valve Technology Requirements Under the New MDR

Although the pandemic has delayed the MDR’s validation date, it has not diminished the importance of this new regulation.

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.

New Products and Services

Linear stepper stages, tubing, Bluetooth modules, and more.

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.