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

Medtech stories we missed this week: Jan. 26, 2018

From Attune Medical receiving FDA 510(k) clearance to Synapse Medical having CE Mark approval, here are some medtech stories we missed this week but thought were still worth mentioning. 1. Attune Medical gets FDA 510(k) clearance Attune Medical announced in a Jan. 8 press releasethat it has received FDA 510(k) clearance for its EnsoETM model

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

Report: CMS nixes plans for pathway for expedited medical device coverage

The Centers for Medicare & Medicaid Services has cancelled plans to create a new regulatory pathway that aimed to accelerate medicare coverage for medical devices, according to a ModernHealthcare report. The federal agency reportedly withdrew the proposition, known as Excite, from review at the White House’s Office of Management and Budget this month, nine months after […]

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

Northwire expands biocompatibility compliance

Northwire (Osceola, Wis.) announced that it has finished additional testing to certify its BioCompatic material line to be in accordance with ISO 10993-10 irritation and skin sensitization requirements. The company’s BioCompatic material is designed to create optimized, safe and dependable medical cables while meeting biocompatibility standards under USP Class VI and compliance to ISO 10993-5 cytotoxicity.

Light-based medical products: What you need to know

Photonics technologies are everywhere but need a deft touch to integrate into light-based medical products. Scott Wohlstein, The Photonics Group Much like electronics is the study of the electron, photonics is the study of the photon and includes its generation/emission, transmission, detection and analysis. Incandescent/fluorescent light sources, UV lamps, lasers, LEDs, lenses, fiber optics, detectors

How laser marking could solve the medical device industry’s UDI challenges

Here are five ways that laser marking could provide advantages to medical device companies when it comes to meeting permanent marking requirements under FDA’s Unique Device Identification program. Ashir Thakore, SABIC As the U.S. Food and Drug Administration (FDA) implements its phased Unique Device Identification (UDI) program across medical device classes, OEMs are considering methods