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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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Medical Device Classification Product Codes - Guidance for Industry and Food and Drug Administration Staff

April 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...

Regulatory Controls

April 11, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

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 Committee

April 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

AdvaMed 2013: The MedTech Conference

April 8, 2013 3:37 pm | by MDT Staff | Events

AdvaMed 2013 is the leading MedTech conference in North America, bringing more than 1,000 companies together in a uniquely multifaceted environment for business development, capital formation, innovative technology showcasing, world-class educational opportunities and networking.

FDA Postpones Orthopedic Devices Panel on Shortwave Diathermy Devices

April 5, 2013 9:29 am | by Mass Device | News | Comments

The FDA's Orthopaedic & Rehabilitation Devices Panel postponed today's meeting over scheduling conflicts that meant key players couldn't attend. The meeting was convened to discuss a possible reclassification of shortwave diathermy devices, which are used to therapeutically heat tissue with an electric current with applications in joint inflammation treatments and physiotherapy.

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Class I Medical Device Recall: Animas Corporation 2020 Insulin Infusion Pump

April 5, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

Animas has identified a component issue affecting Animas(R) 2020 Infusion Insulin Pumps manufactured from March 1, 2012 to November 30, 2012. The component issue may trigger the pumps to sound a false alarm or warning related to one of the following...

POSTPONED: April 5, 2013 Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Meeting Announcement

April 4, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

The Food and Drug Administration (FDA) is postponing the meeting of the Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee scheduled for April 5, 2013.  The meeting was announced in the Federal Register of November 29, 2012 (77 FR 71195). The meeting is postponed because key participants were unavailable due to unforeseen scheduling conflicts.

FDA's New Global Cardiovascular Registry to Start with Transcatheter Heart Valves

April 3, 2013 3:26 pm | by Mass Device | News | Comments

The FDA plans to launch a global cardiovascular medical device registry, with initial efforts to focus on coordinated efforts to monitor transcatheter heart valve technology. The federal watchdog agency will host a public meeting later this month to discuss goals and strategies for organizing such an effort.

FDA Issues New Guidance on Medical Device User Fee Refunds and Exceptions

April 2, 2013 1:44 pm | by Mass Device | News | Comments

The FDA issued new guidance this month detailing cases in which a medical device manufacturer may be eligible for a refund of the user fee paid for agency review. The federal watchdog agency described user fee protocols for both 510k and premarket approval applications.

Notice of Change of Meeting Schedule: April 25, 2013 Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee

April 2, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of Wednesday, February 27, 2013 (78 FR 13347). The meeting was shortened to one day, as it was later determined that in order to be more financially prudent all three topics could fit into one day.

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Guidance for Industry and Food and Drug Administration Staff - User Fees and Refunds for Premarket Approval Applications and Device Biologics License Applications

April 1, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

During the review of a premarket submission, the review clock is impacted by both FDA?s and Industry's action. The Medical Device User Fee Amendments of 20121 (MDUFA III), amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) to authorize FDA to...

Guidance for Industry and Food and Drug Administration Staff - User Fees and Refunds for Premarket Notification Submissions (510(k)s)

April 1, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

During the review of a premarket submission, the review clock is impacted by both FDA's and Industry's action. The Medical Device User Fee Amendments of 20121 (MDUFA III), amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) to authorize FDA to...

Biotronik Lands CE Mark for MRI-Safe Iforia Defibrillator

March 28, 2013 12:37 pm | by Mass Device | News | Comments

Biotronik said it's planning a mid-year launch in Europe for its Iforia MRI-safe pacemaker now that EU regulators have given the device CE Mark approval. The German medical device company said the Iforia is the world's 1st ICD/CRT-D device using the DF4 connector to be approved for magnetic resonance imaging, according to a press release.

Recall: Spacelabs Healthcare Pulls Anesthesia Workstations over Excess CO2 Risk

March 27, 2013 4:33 pm | by Mass Device | News | Comments

Washington-based Spacelabs Healthcare recalled a slate of its Spacelabs BleaseSirius and BleaseFocus anesthesia workstations as well as certain absorbers contained in service kits over concerns that they may contain a defect which could result in excess carbon dioxide in the gas delivered to a patient. The FDA slapped the recall with Class I status...

Class I Medical Device Recall: Spacelabs Medical, Inc., Spacelabs Anesthesia Workstations and Service Kits

March 26, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

These products are used in the hospital environment and in locations not requiring mobility of the products. They provide respiratory support to deliver oxygen, air, and nitrous oxide in a controlled manner to various patient-breathing circuits with or without the use of a mechanical ventilator, and may be used to deliver anesthetic vapor.

FDA Proposes New Rules for Heart Defibrillators

March 22, 2013 11:26 am | by The Associated Press | News | Comments

The Food and Drug Administration will require makers of heart-zapping defibrillators to submit more data on their safety and effectiveness following years of recalls of the emergency devices. Defibrillators use electric shocks to jolt the heart back to normal after patients collapse from cardiac arrest.

Consumer Information on: Resolute Integrity Zotarolimus-Eluting Coronary Stent System (Resolute Integrity) - P110013S005

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

  This is a brief overview of information related to FDA’s approval to market this product. See the links to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.  

Analyst: FDA OK Unlikely for Abbott Heart Device

March 21, 2013 1:09 pm | by The Associated Press | News | Comments

A medical device industry analyst says Abbott Laboratories is unlikely to win approval anytime soon for its device used to repair heart valve problems, following a tepid endorsement by government experts. A Food and Drug Administration panel of heart experts voted 5-3 on Wednesday that the...

GOP Reps Call for an FDA Advisory Panel to Boost Agency Performance

March 21, 2013 12:07 pm | by Mass Device | News | Comments

A duo of House Energy & Commerce Committee Republicans announced this week that they plan to take a closer look at the FDA's life sciences initiatives, suggesting that the agency may need an advisory panel to watch its performance. Reps. Michael Burgess (R-Texas) and Joe Pitts (R-Pa.) committed to taking a stronger hand in oversight of the FDA.

PMA Final Decisions for January 2013

March 20, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

Below are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions. This list is generated on a monthly basis. A PDF document that contains the "Approval letter and Summary of Safety and Effectiveness" is being added to this listing for each PMA. The PMA number will appear as a link if this document is available.

FDA Puts Highest-Risk Category on Symbios Infusion Pump Recall

March 19, 2013 4:10 pm | by Mass Device | News | Comments

Symbios Medical Products recalled certain lots of its GOPump Elastomeric Infusion PumpKit systems over concerns that a component that moderates the flow of medicine from the pump may fail and cause an overdose. The FDA placed Class I status on the recall, a category reserved for issues which "may cause serious adverse health consequences, including death," according to an agency notice.

Consumer Information on: Argus II Retinal Prosthesis System - H110002

March 11, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

The Argus II Retinal Prosthesis System is the first implanted device to treat adults with severe retinitis pigmentosa. The System has three parts: a small electronic device implanted in and around the eye, a tiny video camera attached to a pair of...

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