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 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?”
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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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.
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 AnnouncementApril 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.
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.
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 CommitteeApril 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 ApplicationsApril 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 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.
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 KitsMarch 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.
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) - P110013S005March 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.
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...
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.
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.
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.