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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.

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...

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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.  

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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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Hauser's FDA Rx: The FDA needs an NTSB

March 10, 2013 10:25 pm | by Mass Device | News | Comments

Dr. Robert Hauser hopes to push a major change at the FDA, looking to shift the monitoring of medical devices and drugs that are already on the market from the FDA to an independent entity. Hauser, a long-time patient safety advocate and vocal FDA critic, is aiming to sell Capitol Hill on a new structure for the U.S. healthcare regulation system akin to how the nation deals with transportation safety.

Draft Guidance for Industry and Food and Drug Administration Staff - Recommendations for Labeling Medical Products to Inform Users that the Product or Product Container is not Made with Natural Rubber Latex

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

The purpose of this guidance is to make recommendations on the appropriate language to include in the labeling of a medical product to convey that natural rubber latex was not used as a material in the manufacture of the product or product container...

FDA Updates Guidance on Pulse Oximeter Applications

March 7, 2013 9:29 am | by Mass Device | News | Comments

The FDA issued new guidance governing premarket notification submissions for pulse oximeters. The new guidelines apply to all 510(k) submissions for the non-invasive blood oxygen level and pulse rate measuring devices. In the guidance, published March 4, the FDA specified new rules for identifying, testing and assuring safety for the systems.

Class I Medical Device Recall: Ad-Tech Medical Instrument Corporation, Macro Micro Subdural Electrodes

March 7, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

There is a concern the microelectrodes are defective and may cause injury to the brain. As a result, there is the potential for scraping (abrasion) of brain tissue and for broken pieces to remain in the brain tissue when the physician removes the...

FDA Releases Draft of Sunshine Law Financial Disclosure Guidelines

March 6, 2013 2:29 pm | by Mass Device | News | Comments

The FDA published a draft of the Sunshine Act financial disclosure guidelines that will take full effect by August 1, 2013. The 35-page document details all physician-relationship rules companies will have to follow when applying for marketing applications with the FDA.

Data Standards and Terminology Standards for Information Submitted to CDRH

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

The Center for Devices and Radiological Health (CDRH) encourages manufacturers to use data and terminology standards in pre-market submissions and post-market reports for medical devices. The FDA can review and analyze data and information more quickly...

Types of Communication During the Review of Medical Device Submissions - Draft Guidance for Industry and Food and Drug Administration Staff

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

During the review of a premarket submission, FDA?s practice has been to communicate with applicants1 through either a formal communication (such as a Major Deficiency Letter or an additional information request issued through a letter, or through phone...

AdvaMed Fights to Keep User Fees Out of Sequester Cuts for FDA

February 26, 2013 4:20 pm | by Mass Device | News | Comments

The medical device industry doesn't want user fees paid by industry to be included in a series of cuts slated for the FDA's budget this week. The federal watchdog agency will have $210 million, or about 5.1% of its $4.1 billion budget, cut from its 2013 budget March 1 as a result of sequestration, the bargain between the White House and Congress.

FDA Issues Draft Guidance on Distinguishing Medical Device Recalls from Product Enhancements

February 25, 2013 2:38 pm | by Mass Device | News | Comments

The FDA issued draft guidance for medical device companies on distinguishing between a recall and a product enhancement that doesn't need 1, saying it recognizes that "continuous improvement activities" "often have a favorable impact on medical device safety and are part of ongoing efforts to design and manufacture devices that meet the needs of the user and patient."

Who Will Win The Battle For Tougher Medical Device Regulations, the European Commission or Device Manufacturers?

February 25, 2013 12:04 pm | by GlobalData | News | Comments

Faulty breast implants at risk of bursting, and defective metal-on-metal hip prostheses, both raising grave concerns about patient health and long-term toxicity, have plagued the reputation of the medical device industry over the past year, states a GlobalData healthcare analyst.

Class I Medical Device Recall: Lumenis Limited, Lumenis VersaCut Tissue Morcellator

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

Lumenis Limited is recalling certain models of VersaCut Morcellator devices to correct its labeling. There is a potential for air embolisms to occur if the aspiration tubing is hooked up backwards to the aspiration control box housing. This product may cause serious adverse health consequences, including death.

Distinguishing Medical Device Recalls from Product Enhancements and Associated Reporting Requirements - Draft Guidance for Industry and Food and Drug Administration Staff

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

Defects or performance failures of marketed medical devices can pose serious risks to public health. Recalls serve both to correct a defect in current and future devices and to notify users of potential risks and steps to minimize the impact of device...

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