FDA/​Regulatory

Briefs: Manufacturing & Prototyping

Disposable Device Treats Severe Side-Effect of Cancer

The device eliminates oral mucositis, a side effect of chemo- and radiation therapy.

Features: FDA/Regulatory

Q&A: How Do You Protect Your IP?

Philip Nelson, a partner with Knobbe Martens, provides some insights for device companies facing challenges with intellectual property.

From the Editor: FDA/Regulatory

From the Editor - COVID-19 Ushers in New Technologies and a New Paradigm for the Medical Device Industry

FDA has issued multiple emergency use authorizations, loosened regulations for telemedicine, and eased the requirements for production...

Blog: Design

FDA Authorizes First COVID-19 Test for Patient At-Home Sample Collection

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: Medical

FDA Creates New Program to Expedite Development of Coronavirus Treatments

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

From the Editor: FDA/Regulatory

From the Editor — FDA Launches eSTAR: Voluntary Electronic Submission Program for 510(k)s

FDA has kicked off a new voluntary electronic submission program for 510(k)s.

Features: Test & Measurement

Your MDR Strategy: Start with a Gap Analysis

How to make sense of the 566-page Medical Device Regulation (MDR). This article focuses on a strategy to address material information and what should be included in a gap analysis.

Features: FDA/Regulatory

Class I Manufacturers: 8 Steps to Tackle EU MDR Compliance

Why Class I manufacturers should not place European Medical Device Regulation (EU MDR) compliance at the end of their to-do lists.

Blog: FDA/Regulatory

FDA Expedites Review of Diagnostic Tests to Combat COVID-19

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: FDA/Regulatory

FDA Issues Emergency Use Authorization for Ventilators

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: FDA/Regulatory

COVID-19: FDA Continues to Facilitate Access to Crucial Medical Products, Including Ventilators

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

Blog: Medical

FDA Adds More Dates for Town Halls for COVID-19 Test Developers

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: FDA/Regulatory

COVID-19: FDA Expands Remote Patient Monitoring

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: FDA/Regulatory

COVID-19: FDA Issues Diagnostic Emergency Use Authorization; Expedites Availability of Diagnostics

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

Blog: FDA/Regulatory

FDA Suspends Foreign and Domestic Inspections Due to Coronavirus

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...

From the Editor: Medical

From the Editor — Is FDA Making Progress or Still a Victim of Too Few Resources and Too Little Power?

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

Technology Leaders: Test & Measurement

Preparing for MDR? Don’t Overlook the Analytical Evaluation Threshold

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...

Briefs: FDA/Regulatory

Good Design Controls Are Critical to Avoiding FDA Issues

Medical device companies recognize that having an emphasis on design controls helps to assure good design and engineering practices that yield high-quality solutions. This is critical...

From the Editor: Medical

From the Editor — Most Medical Device OEMs Not Ready to Comply with 2020 EU Regulation

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...

From the Editor: Medical

From the Editor — The Modern FDA: A New Pathway Gets Under Way

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...

Briefs: Medical

A Fast, Simple Sampling Method for Characterizing Volatile Organic Compounds Emitted from Medical Devices

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

Products: Manufacturing & Prototyping

Medical Design Briefs Product Focus (September 2019): Pumps/Valves

Gradient Valves

Clippard, Cincinnati, OH, has released gradient valves that feature multiple two-way, normally closed solenoids connected around a central body. The...

From the Editor: Wearables

From the Editor — Digital Health: Lessons Learned So Far from FDA’s Test Phase

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: FDA/Regulatory

Capturing Unique Device Identifier Data on Non-Sterile Orthopedic Implants

Now that medical devices are being labeled and uniquely identified to meet the requirements of the U.S. Food and Drug Administration (FDA) Unique Device Identifier...

Features: Design

Industrial CT is Hip: Quality of Life Enhanced with Additive Manufacturing

Orthopedic devices play a crucial role in providing pain relief, improving mobility, and enhancing the quality of life for patients suffering from musculoskeletal...

Briefs: FDA/Regulatory

Advanced Design Tools for Additively Manufactured Medical Devices

While the regulatory and validation burden can be high, it's not surprising that the medical device industry is one of the earliest adopters of additive manufacturing (AM, aka...

Features: FDA/Regulatory

Why Cloud QMS Better Supports Regulatory Compliance

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: Medical

From the Editor — FDA Moves to Increase Transparency of Medical Device Reporting

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...

Briefs: Imaging

Imaging System Helps Surgeons Remove Tiny Ovarian Tumors

Ovarian cancer is usually diagnosed only after it has reached an advanced stage, with many tumors spread throughout the abdomen. Most patients undergo surgery to remove as many of...