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Preparing for Medical Electronics RoHS Compliance

May 20, 2013 2:33 pm | by George Karalias, Director of Marketing & Communications, Rochester Electronics | Blogs | Comments

Next July, certain medical electronics will fall under the scope of RoHS—the European Union’s Restriction on Hazardous Substances. In terms of the electronics industry, that is now a tight deadline for manufacturers. Medical devices that have so far been exempt from RoHS fall into scope under the RoHS Recast (RoHS 2) beginning in July 2014.

Center for Devices and Radiological Health Appeals Processes: Questions and Answers About 517A - Draft Guidance for Industry and Food and Drug Administration Staff

May 16, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

This draft guidance document provides CDRH proposed interpretation of key provisions of Section 517A of the Food, Drug and Cosmetic Act (FD&C Act), which was added by section 603 of the FDA Safety and Innovation Act (FDASIA) of 2012, as those provisions..

Center for Devices and Radiological Health Appeals Processes - Guidance for Industry and Food and Drug Administration Staff

May 16, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

This guidance document describes the processes available to outside stakeholders to request additional review of decisions or actions by CDRH employees. This guidance supersedes “Medical Device Appeals and Complaints: Guidance for Dispute Resolution,” and “Resolving Scientific Disputes Concerning The Regulation of Medical Devices, A Guide to Use of the Medical Devices Dispute Resolution Panel; Final Guidance for Industry and FDA."


Why Medtech Startups Are Moving to Ireland

May 13, 2013 2:33 pm | by Eddie Goodwin, Manager, Boston Office, Enterprise Ireland | Blogs | Comments

It’s no secret that getting a medical device to market can be a lengthy, frustrating process. Facing the new medical device excise tax and lack of clarity from the FDA around regulatory policies, medtech startups are now starting to rethink launching in the U.S.

PatientsLikeMe and CISCRP Team up with Sanofi to Spotlight Medical Heroes and Clinical Trial Participation

May 13, 2013 10:00 am | by The Associated Press | News | Comments

CAMBRIDGE, Mass.--(BUSINESS WIRE)--May 13, 2013--PatientsLikeMe and the nonprofit Center for Information and Study on Clinical Research Participation (CISCRP) announce a new partnership with global healthcare leader Sanofi (NYSE: SNY) to raise awareness about the benefits of participating in...

Meeting Announcement: July 18, 2013 Dental Products Panel of the Medical Devices Advisory Committee

May 13, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

On July 18, 2013, the committee will discuss and make recommendations on the proposed regulatory classification for dental devices known as Endosseous Dental Implants (Blade-form), one of the remaining preamendments Class III devices. The Class III blade-form endosseous dental implant is a device placed into the maxilla or mandible and composed of biocompatible material with sufficient strength to support a dental restoration.

Medical Device Global Labeling Strategies Conference

May 9, 2013 2:07 pm | by MDT Staff | Events

Gain best practices in overcoming international labeling challenges at the Medical Device Global Labeling Strategies Conference, July 24-25, 2013 in Minneapolis, MN. This premier marcus evans event will bring together leading medical device labeling professionals to discuss how to successfully create a label on both a national and international scale.

Meeting Announcement: June 13, 2013 Microbiology Devices Panel of the Medical Devices Advisory Committee

May 8, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

The committee's discussion will involve making recommendations regarding regulatory classification to either confirm class I or reclassify these devices into class II with special controls. The committee will address issues such as device performance and public health impact to determine whether special controls are needed to ensure the safety and effectiveness of these tests through their total product life cycle.


Much Ado About Nothing: The Impact of the Medical Device Excise Tax

May 7, 2013 3:19 pm | by Michael Lewis, Writer, Money Crashers Personal Finance | Blogs | Comments

Critics of the new 2.3% medical device excise tax are hitting new heights with their claims of dire consequences. Conservative blogger and attorney Johnathan Emord blogged that the tax will "wipe out an entire industry," and further asserts that the tax is "one of the most draconian tax burdens in history." What are the facts? Is the industry overreacting?

Obesity Treatment Devices

May 3, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

Obesity is a major public health concern in the United States and has been linked to many health problems such as heart disease, stroke, diabetes, high blood pressure, sleep disorders, and breathing problems. Obesity (an excessive amount of body fat)...

Meeting Announcement: June 27, 2013 Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee

May 3, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

On June 27, 2013, during session I, the committee will discuss and make recommendations regarding the proposed classification of sorbent hemoperfusion systems, one of the remaining preamendments class III devices. The class III sorbent hemoperfusion system is a device intended for the treatment of poisoning, drug overdose, hepatic coma, and metabolic disturbances.

AACR Opposes Bill to Exempt Cigars From FDA Regulation

May 1, 2013 9:00 am | by AACR | News | Comments

The American Association for Cancer Research (AACR) formally issued letters to all members of the House of Representatives and the Senate urging them to oppose recently introduced legislation that would exempt many cigars from regulation. The FDA currently regulates cigarettes, smokeless tobacco and roll-your-own cigarette tobacco, and...

510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device, May 17, 2013

April 25, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

The purpose of the meeting is to discuss FDA’s past, present, and future policy on 510(k) Modifications with external stakeholders. FDA seeks comment from stakeholders on different options, both in the form of submissions to the docket for the Federal Register notice associated with this meeting and in discussion during the public meeting.


FDA's next-gen medtech surveillance bets heavily on unique device identifiers

April 24, 2013 1:47 pm | by Mass Device | News | Comments

The FDA laid out plans to revamp its postmarket surveillance of medical devices, and a large part of that has to do with finalizing and implementing a long-awaited Unique Device Identifier program to better track and monitor devices. The federal watchdog agency aims this year to finalize a UDI rule...

Medical device tax: Sen. Max Baucus's retirement and its effect on repeal

April 24, 2013 12:57 pm | by Mass Device | News | Comments

It's unlikely that his waning days as chairman of the Senate Finance Committee will see Sen. Max Baucus (D-Mont.) having a "Come-to-Jesus" moment on the medical device tax, but his retirement does change the game on repealing the levy.

Medical device tax helps push Spectranetics further into the red in Q1

April 24, 2013 12:49 pm | by Mass Device | News | Comments

Colorado-based medical device maker Spectranetics (NSDQ:SPNC) broke out the red ink in 2013, blaming the swing partly on the newly implemented medtech excise tax, which requires that companies pay a 2.3% levy on all U.S. sales of applicable medical devices.

Reports: Obamacare architect Baucus to step down at year's end

April 23, 2013 2:34 pm | by Mass Device | News | Comments

Sen. Max Baucus (D-Mont.) is reportedly planning to retire when his current term ends this year, according to multiple news outlets today, potentially removing a key opponent to the medical device industry's push to repeal a 2.3% tax on U.S. medtech sales.

FDA Announces Medwatcher—A Mobile App to Submit Device Problems

April 23, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

MedWatcher is a mobile application (app) that allows individuals to submit voluntary reports of serious medical device problems to the FDA using a smart phone or tablet. The app makes it easier and faster for healthcare professionals, patients and caregivers to send voluntary reports of medical device problems to the FDA, compared to the traditional reporting methods.

The Malware Threat

April 22, 2013 2:06 pm | by Sean Fenske, Editor-in-Chief, MDT | Blogs | Comments

When my mother tells me that her computer is running slow and she needs me to “clean it up” for her, I never imagined the day she might be calling about the same problem with a medical device. While I’d obviously not have the same access to it that I have on a computer, it does reflect a scary situation in medical device technology today.

"It's Time to Act" on MedTech Tax Repeal, Reps Paulsen and Kind Say

April 22, 2013 1:15 pm | by Mass Device | News | Comments

House Representatives Erik Paulsen (R-Minn.) and Ron Kind (D-Wisc.) are looking for immediate action on the medical device tax. The House of Representatives' lead medtech tax repeal bill co-sponsors urged immediate action to strike what they called an "onerous policy that is harming the great American success story."

Class I Medical Device Recall: CareFusion Corporation, Alaris PC Unit (Model 8015) with Software Version 9.12

April 22, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

Reason for Recall: CareFusion has received reports of a communication error on the Alaris PC unit (model 8015) with software version 9.12 when the Alaris EtCO2 module or Alaris SpO2 module is attached. Use of this product may cause serious adverse...

Class I Medical Device Recall: Stryker Orthopaedics - ShapeMatch Cutting Guide

April 18, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

Stryker Orthopaedics has become aware of potential issues associated with internal processes for planning cases and producing ShapeMatch Cutting Guides. The parameters of the manufactured cutting guides did not meet the surgeon’s pre-operative planning parameters entered via the web application.

60601 Ed 3, What Happened?

April 17, 2013 4:53 pm | by Rob Keur, Regulatory Affairs Expert, StarFish Medical | Blogs | Comments

60601 edition 3 is possibly the biggest change in the regulatory side of medical device development since the introduction of the FDA’s QSR. Until now, electrical safety testing was a black box test wherein a sample device was submitted and it passed or failed depending on a set of specific physical tests. There was no consideration of how the device was developed, just, “Is the device electrically safe?”

FCC names new healthcare initiatives director

April 16, 2013 9:12 am | by Mass Device | News | Comments

After announcing the search back in December, the FCC hired Matthew Quinn as director of healthcare initiatives. Quinn is a veteran of U.S. government agency positions, including at the National Institute of Standards & Technology, and the Agency for Healthcare Research & Quality.

Court: Can Human Genes be Patented?

April 15, 2013 10:29 am | by Jesse J. Holland, Associated Press | News | Comments

DNA may be the building block of life, but can something taken from it also be the building block of a multimillion-dollar medical monopoly? The Supreme Court grapples Monday with the question of whether human genes can be patented.

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