Webinar: Where should medical device companies launch products first?

This webinar was presented live on Tuesday, Feb. 27, 2018. Click below to watch on demand.     The regulatory environments are changing, particularly in Europe. In the next few years, we are expecting a complete overhaul of the regulatory standards practiced by the E.U. These events will dramatically change how (and where) medical device

Software is a top cause of medical device recalls: Here’s what you can do

Stericycle Expert Solutions recently conducted a five-year assessment of recall trends, based on its quarterly Recall Index studies. The results show surprising missteps from medical device companies, especially where software is concerned. We asked Chris Harvey, director of recall solutions at Stericycle to answer some questions about the recall trends and offer some advice on

Charting the FDA’s course for 2018-2020

By: Jeff Shuren, M.D., J.D. Since 2012, we at the Center for Devices and Radiological Health have set as our North Star the vision of patients in the U.S. having access to high-quality, safe, and effective medical devices of public health importance first in the world. “First in the world” is not about a competition

Webinar: The top medtech stories of 2017

This webinar was presented live on Tuesday, January 30, 2018. Click below to watch on demand.     The medtech industry saw its transformation accelerate in 2017: Whether it’s the roster of largest companies, business models or the regulatory environment, times are a-changing. Competition is also heating up in areas including diabetes care and robotic

FDA delays contentious medical device intended use rule

By Stewart Eisenhart, Emergo Group US medical device regulators at the Food and Drug Administration has indefinitely delayed implementation of part of a final rule covering intended use determinations by the agency following industry questions and concerns. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are

FDA announces deadline for UDI compliance for low-risk medical devices

By Stewart Eisenhart, Emergo Group The US Food and Drug Administration has formally pushed back some Unique Device Identification (UDI) compliance deadlines by two years for qualifying low-risk medical devices. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not necessarily

FDA, FTC warn companies over deceptive opioid cessation products

The FDA and the Federal Trade Commission have posted joint warning letters to companies that make and distribute opioid cessation products. The two watchdogs warned that the companies are illegally marketing their unapproved products as treatments or even cures for people with opioid addiction and withdrawal. Selling unapproved products as therapies for opioid addiction is

How FDA’s digital health plan is shaking up its review process

FDA is asking questions about how to overhaul digital health product regulation and relying on expertise within the industry to do so, according to Bakul Patel, FDA’s associate center director for digital health, who recently spoke with MDO. In late 2017, FDA launched the Digital Health Innovation Action Plan. Within that plan is a recipe

What should really trigger a CAPA?

When should a problem with a medical device trigger a CAPA (Corrective Action and Preventative Action)? Jon Speer at Greenlight Guru has some thoughts.  Jon Speer, Greenlight Guru After years of working with medical device companies, we’ve found that there is a particular area that is often rife with issues for companies: CAPA (Corrective Action and Preventative Action).

3M submits 510(k) for steam sterilization system

3M has submitted an application to receive FDA 510(k) clearance for its Attest Super Rapid System for steam sterilization. The steam sterilization system can provide biological indicator results in 24 minutes. A faster readout time for steam will help improve patient safety while increasing workflow for sterilization professionals. “The focus of our sterilization science at

NSF International appoints new executive director of medical device certification and training

NSF International has appointed FDA veteran Robert Ruff to the role of executive director of medical device certification and training. Ruff will offer expert training and certification services to NSF International’s medical device industry clients. He will be responsible for managing key sectors of the company’s medical device business. “Rob brings the utmost integrity and

Medtech stories we missed this week: Jan. 19, 2018

From Privi Medical’s FDA clearance to OrthoXel getting FDA clearance and CE Mark approval, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. Privi Medical wins FDA nod for hemorrhoid device Privi Medical has received FDA clearance for its Instalief Hemorrhoids Treatment device, according to a Jan. 18 news

FDA to expedite release of recall information

Douglas Stearn, FDA When FDA identifies that a product it regulates violates the law, it protects the public by working with the manufacturer and distributors to facilitate the product’s recall (i.e., removal from the marketplace or product correction). Among other actions, FDA assures that the public is warned when products present the most significant public

FDA releases top 3 medical device regulation goals

FDA medical device regulators’ top priorities over the next three years include improving employee engagement, increasing simplicity and building collaborative communities, according to a new Strategic Priorities paper that FDA’s CDRH released today. The agency said the priorities further its overall goal of providing Americans with more timely access to the latest high-quality, safe and effective medical devices.

FDA needs to improve medical device regulation, GAO says

FDA is lacking performance metrics when it comes to tracking whether its medical device regulators are following a “least burdensome” approach toward asking applicants for additional information, according to a new report from the U.S. Government Accountability Office. The GAO says in the report highlights: “Until such measures are developed and used, FDA will not