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?”
Critics of the new 2.3% medical device excise tax are hitting new heights with their claims of...
Center for Devices and Radiological Health Appeals Processes: Questions and Answers About 517A - Draft Guidance for Industry and Food and Drug Administration StaffMay 16, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments
This draft guidance document provides CDRH proposed interpretation of key provisions of Section 517A of the Food, Drug and Cosmetic Act (FD&C Act), which was added by section 603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 StaffMay 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."
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 ParticipationMay 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...
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.
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 CommitteeMay 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.
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 CommitteeMay 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.
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, 2013April 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.
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...
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.
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.
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.
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.
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 9.12April 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...
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.
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.
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.
Medical Device Classification Product Codes - Guidance for Industry and Food and Drug Administration StaffApril 11, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments
Since the passage of the May 28, 1976 Medical Device Amendments to the Food, Drug and Cosmetic Act (FD&C Act), the Classification Regulation Panels (21 CFR Parts 862-892) have been the basis for CDRH's Classification Product Code structure and...
Federal law (Federal Food, Drug, and Cosmetic Act, section 513), established the risk-based device classification system for medical devices. Each device is assigned to one of three regulatory classes: Class I, Class II or Class III, based on the level...
Meeting Announcement: May 21-22, 2013 Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory CommitteeApril 9, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments
On May 21, 2013, the committee will discuss and make recommendations regarding the classification of one of the remaining preamendments class III devices, shortwave diathermy for all other uses except for the treatment of malignancies. The class III shortwave diathermy is a device that applies electromagnetic energy to the body in a radiofrequency band ranging between 13 megahertz to 27.12 megahertz
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