FDA/​Regulatory

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...

Proposed Surgical Devices Standard Covers Properties for Nickel Titanium Alloy

ASTM International’s medical and surgical devices committee (F04) is developing a proposed standard for a wrought nickel-titanium alloy. The alloy covered by the...

Landmark FDA Clearance May Accelerate Compelling Digital Therapeutics

Read on to learn more about a significant step forward in the rapidly evolving field of digital therapeutics (DTx).

From Manufacturing to Medicine: A Shared Mission

Through collaboration SAE International, Performance Review Institute (PRI) and Medical Design Briefs (MDB) extend their knowledge throughout the life sciences industry, driving innovation in...

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.

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.

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...

Why Standardization Matters in Pulsed Electric Field Generation for Clinical Electroporation

Pulsed field ablation is a nonthermal method of tissue ablation technology that uses high amplitude pulsed electrical fields to create irreversible electroporation in tissues. Read on to learn more about it.

A Look at Vaporized Hydrogen Peroxide as a Sterilization Option

The changing regulatory landscape and innovation of medical products is driving an interest in additional options for medical product sterilization. Read on to learn what this means.

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...

ANSI/AAMI ST24 Updated to Reflect Technological Changes

As leaders in the medical device industry seek ways to optimize the application of ethylene oxide (EO) sterilization, it is more important than ever to ensure that medical device...

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.

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.

ISO 80369-7: Changing the Standard for Luer Connectors

ISO 80369 Part 7, the long-awaited replacement to ISO 594, introduced a number of changes to the standard governing dimensions and performance requirements of Luer connectors.

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...

MedAccred: NuVasive, Zimmer Biomet Become Pending Members

NuVasive and Zimmer Biomet, both leading innovators in the medical devices industry, have become Pending Subscribers to the MedAccred accreditation program.

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 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...

Guest Editorial

Written by Katie Falcone, Scientific Support Manager, Datwyler, this article addresses the dangerous implications of micro material contamination.

AdvaMed: EPA’s EtO Proposals Create Significant Risk of a Healthcare Crisis

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.

PRI Launches New Program to Help Companies Improve Manufacturing, Quality

The Performance Review Institute (PRI) has launched a new service designed to help companies improve manufacturing and quality management and improve business...

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™....