Keyword: FDA Compliance/​Regulatory Affairs

Medical

Stories

Features: Software

Radiation medicine pioneer Elekta is growing fast. In anticipation of regulatory changes requiring more documentation and labeling, the company implemented a...

News: Medical

Boston Scientific Corporation has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its EMBOLD™ Fibered Detachable Coil, a device that is...

From the Editor: Medical
FDA has created a “Catalog of Regulatory Science Tools,” in which it provides a comprehensive list of peer-reviewed resources for medical device developers.
Features: Medical
Understand what part 18 of the 1099318 standard means for your product’s overall life cycle.
Briefs: Medical
The updated standard allows the manufacturer to assess and mitigate risks that are associated with correct use and use errors.
Features: IoMT

As summer 2020 gives way to fall and we continue grappling with unprecedented challenges, healthcare industry efforts persist to ensure that medical supplies are available when and where they are...

Blog: Medical

Yes, there will be a day when the U.S. EUA, Emergency Use Authorization Act, will be lifted, the medical device industry goes back to reality, and the FDA regains control of the medical approval process...

Features: Medical
A number of manufacturers are still in the process of confirming who qualifies as an "Economic Operator."
Blog: Medical

The U.S. Food and Drug Administration (FDA) has authorized the first diagnostic test with a home collection option for COVID-19. Specifically, the FDA re-issued the...

Blog: Design

The U.S. Food and Drug Administration (FDA) has established new program specifically geared toward expediting the development of potentially safe and effective...

Features: Regulations/Standards
Why Class I manufacturers should not place European Medical Device Regulation (EU MDR) compliance at the end of their to-do lists.
From the Editor: Regulations/Standards
FDA has kicked off a new voluntary electronic submission program for 510(k)s.
Blog: Medical

The U.S. Food and Drug Administration (FDA) has made policy changes to respond to the urgent need for even faster testing availability. Although laboratories could use the EUA...

Blog: Regulations/Standards

The U.S. Food and Drug Administration (FDA) took action May 25, 2020, to make more ventilators available to healthcare personnel in the United States. FDA issued an emergency use...

Blog: Regulations/Standards

The U.S. Food and Drug Administration took significant action to help increase the availability of ventilators and accessories, as well as other...

Blog: Regulations/Standards

On Wednesday, March 25, 2020 (3–4 p.m. Eastern), the U.S. Food and Drug Administration (FDA) will host a virtual Town Hall for clinical laboratories and commercial...

Blog: Medical

The Food and Drug Administration (FDA) has issued a new guidance to provide a policy to help expand the availability and capability of noninvasive remote monitoring devices to facilitate...

Blog: Medical

The U.S. Food and Drug Administration (FDA) has taken two additional significant diagnostic actions during the coronavirus outbreak (COVID-19)...

Blog: Regulations/Standards

FDA is postponing most foreign and domestic inspections through April, effective immediately. Inspections outside the U.S. deemed mission-critical will still be considered on a...

Ask the Expert: Medical
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.
Technology Leaders: Test & Measurement

Medical device manufacturers have a big challenge in preparing for their regulatory device submissions for 2020. In addition to the European Union’s new Medical Device...

From the Editor: Regulations/Standards

FDA says it is continuing to advance its scientific and technical capabilities, but a recent New York Times editorial says the agency is in...

From the Editor: Medical

Under new rules to market medical devices in the European Union (EU), only 27 percent of respondents said they will be fully compliant with the...

Briefs: Regulations/Standards

In 2018, an update on regulations for respiratory medical devices meant that volatile organic compounds (VOCs) emitted from the devices...

From the Editor: Medical

As a first step toward implementation of its recently established Safety and Performance Based Pathway for medical devices, FDA is issuing draft guidances outlining the...

From the Editor: Regulations/Standards

The test phase of FDA’s Software Precertification (Pre-Cert) Program has hit its halfway point. The agency has released an update on its progress and the...

Features: Regulations/Standards

Companies regulated by the U.S. Food and Drug administration (FDA) need to establish current good manufacturing practices (CGMPs) as part of Title 21 CFR part 820 requirements. This...

From the Editor: Regulations/Standards

In the spirit of promoting public transparency, the U.S. Food and Drug Administration’s Center for Devices and Radiological Health is taking a number of...

From the Editor: Regulations/Standards

Spurring Innovation of Brain-Computer Interface Devices FDA is continuing to encourage innovation in novel areas — the latest being novel brain implants, often...

Ask the Expert

John Chandler on Achieving Quality Motion Control

FAULHABER MICROMO brings together the highest quality motion technologies and value-added services, together with global engineering, sourcing, and manufacturing, to deliver top quality micro motion solutions. With 34 years’ experience, John Chandler injects a key engineering perspective into all new projects and enjoys working closely with OEM customers to bring exciting new technologies to market.

Inside Story

Rapid Precision Prototyping Program Speeds Medtech Product Development

Rapid prototyping technologies play an important role in supporting new product development (NPD) by companies that are working to bring novel and innovative products to market. But in advanced industries where products often make use of multiple technologies, and where meeting a part’s exacting tolerances is essential, speed without precision is rarely enough. In such advanced manufacturing—including the medical device and surgical robotics industries — the ability to produce high-precision prototypes early in the development cycle can be critical for meeting design expectations and bringing finished products to market efficiently.