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Class I Medical Device Recall: Thoratec Corporation, HeartMate II Left Ventricular Assist System (LVAS)

April 4, 2012 9:31 am | by U.S. Food & Drug Administration | News | Comments

Detachment of the bend relief from its intended position around the proximal outflow graft may allow the graft to kink or deform, resulting in reduction of blood flow from the HeartMate II LVAS pump, pump/graft thrombosis, or perforation of the outflow...

Altuzan (bevacizumab): Counterfeit Product - Contains no Active Ingredient

April 3, 2012 2:31 pm | by U.S. Food & Drug Administration | News | Comments

The counterfeit product may have resulted in patients not receiving needed therapy.

Wingspan Stent & #8217;s Benefits Don & #8217;t Justify Risks, Panel Concludes

March 30, 2012 1:31 pm | by U.S. Food & Drug Administration | News | Comments

Stryker’s Wingspan stent could be yanked from the market if the FDA heeds March 23 recommendations of its Neurological Devices Panel.

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Shuren Predicts CDRH & #8216;Death Spiral & #8217; Absent Timely MDUFA Passage

March 30, 2012 1:31 pm | by U.S. Food & Drug Administration | News | Comments

CDRH would move into a “death spiral” if Medical Device User Fee Act (MDUFA) legislation is not reauthorized this summer, director Jeffrey Shuren warned at a Senate Health, Education, Labor & Pensions (HELP) committee hearing Thursday.

Celexa (citalopram hydrobromide) - Drug Safety Communication: Revised Recommendations, Potential Risk of Abnormal Heart Rhythms

March 28, 2012 5:31 am | by U.S. Food & Drug Administration | News | Comments

Revised drug label clarifying dosing and warning recommendations.

Guidance: Class II Special Controls Guidance Document: Full Field Digital Mammography System

March 27, 2012 11:30 am | by U.S. Food & Drug Administration | News | Comments

FDA has developed this guidance as the special control to support classification of full-field digital...

New FDA guidance on considerations used in device approval, de novo decisions

March 27, 2012 7:30 am | by U.S. Food & Drug Administration | News | Comments

FDA has published a first-of-a-kind guidance for medical device manufacturers, describing how the benefits...

Pilot Would Reduce Audit Frequency Using Harmonized Regulations

March 23, 2012 2:31 pm | by U.S. Food & Drug Administration | News | Comments

Starting June 5, devicemakers audited according to internationally harmonized regulatory standards could be spared some annual FDA inspections, under a pilot program described in a final guidance.

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U.S. Supreme Court Prometheus Ruling May Limit Future Research

March 23, 2012 2:31 pm | by U.S. Food & Drug Administration | News | Comments

Last week’s U.S. Supreme Court decision on the patent eligibility of a diagnostic could have ramifications for in vitro diagnostic (IVD) devicemakers, limiting investment in novel tests because of uncertainty about what is and is not patentable, a U.S. patent attorney tells D&DL.

Argatroban Injection 50 mg/50 mL (1 mg/mL): Recall - Potential for Visible Particulates

March 23, 2012 10:30 am | by U.S. Food & Drug Administration | News | Comments

Risk of embolization/infarction to organs and potential organ complications.

CDRH Learn (New Module - ISO 13485:2003 Voluntary Audit Report Submission Pilot Program)

March 23, 2012 8:31 am | by U.S. Food & Drug Administration | News | Comments

This presentation explains FDA's new voluntary audit report submission pilot program, which is based on ISO 13485, an international standard utilized in the medical-device sector in many places around the world.

Markey Joined by Victim, Patient Advocate in Call for Closure of Dangerous Medical Device Loophole

March 22, 2012 11:27 am | News | Comments

WASHINGTON, D.C. – Today, with tens of thousands of patients suffering grave health effects as a result of defective medical devices, Congressman Edward J. Markey (D-Mass.) released a comprehensive new report titled “Defective Devices, Destroyed Lives: Loophole Leaves Patients Unprotected...

Markey To Call for Closure of Dangerous Medical Device Loophole

March 22, 2012 7:17 am | News | Comments

WASHINGTON, D.C. – Today, Congressman Edward J. Markey (D-Mass.), a senior member of the Energy and Commerce Committee, which has jurisdiction over the Food and Drug Administration (FDA), will be joined by a patient, surgeon and health advocate at the release of a new report...

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Brilliant Blue G: Recall of Unapproved Drug - Ongoing Investigation of Fungal Endophthalmitis Cases

March 19, 2012 6:30 am | by U.S. Food & Drug Administration | News | Comments

Reports of eye infections in patients who were given Brilliant Blue G during eye surgeries.

Devicemakers Planning To Cut Back on R & #38;D to Pay for Excise Tax

March 16, 2012 2:31 pm | by U.S. Food & Drug Administration | News | Comments

Nearly half of devicemakers (44 percent) in a recent survey said they would pass the costs of the new medical device excise tax on to their customers.

MDUFA Language Published, Public Meeting Set for March 28

March 16, 2012 2:31 pm | by U.S. Food & Drug Administration | News | Comments

The FDA expects to collect $595 million in device user fees by fiscal 2017, according to the FDA’s outline for the reauthorization of the Medical Device User Fee Act (MDUFA).

Guidance for Industry, Third Parties and Food and Drug Administration Staff - Medical Device ISO 13485:2003 Voluntary Audit Report Submission Pilot Program

March 16, 2012 5:31 am | by U.S. Food & Drug Administration | News | Comments

This guidance provides information on the implementation of section 228 of the Food and Drug Administration Amendments Act of 2007 (FDAAA), Public Law 110-85, which amended section 704(g)(7) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act)...

Draft Guidance for Industry and Food and Drug Administration Staff - Class II Special Controls Guidance Document: Nucleic Acid-Based In Vitro Diagnostic Devices for the Detect...

March 16, 2012 5:30 am | by U.S. Food & Drug Administration | News | Comments

This document was developed to support the reclassification of nucleic acid-based in vitro diagnostic devices for the detection of Mycobacterium tuberculosis complex (MTB-complex) in respiratory specimens from class III into class II. These devices are...

Skin Creams, Soaps and Lotions Marketed as Skin Lighteners and Anti-aging Treatments: May Contain the Toxic Metal, Mercury

March 15, 2012 1:31 pm | by U.S. Food & Drug Administration | News | Comments

Products with this toxic metal have been found in at least seven states, are manufactured abroad and often sold in shops in Latino, Asian, African or Middle Eastern neighborhoods and online.

Public Workshop - Medical Device User Fee Program Public Meeting, March 28, 2012

March 15, 2012 9:31 am | by U.S. Food & Drug Administration | News | Comments

The purpose of the meeting is to provide an opportunity for stakeholders to present their views on the draft recommendations for the reauthorization of the medical device user fee program. We welcome this opportunity to hear from stakeholders as we...

Minutes from Stakeholder Meeting on MDUFA III Reauthorization, February 28, 2012

March 15, 2012 9:31 am | by U.S. Food & Drug Administration | News | Comments

FDA reported that they have concluded negotiations with Industry. On February 17, 2012 they reached agreement with all four industry associations Industry on the final details of the fee structure and minor changes to the draft Commitment Letter and...

Consumer Information on: EverFlex Self-Expanding Peripheral Stent System - P110023

March 14, 2012 7:31 am | by U.S. Food & Drug Administration | News | Comments

The EverFlex Self-Expanding Peripheral Stent System is used to re-open narrowed (stenotic) regions of the superficial femoral and proximal popliteal arteries which supply blood to the legs. It consists of two components, the stent and the delivery...

Summary Information for: EverFlex Self-Expanding Peripheral Stent System

March 14, 2012 7:31 am | by U.S. Food & Drug Administration | News | Comments

Labeling, Approval Order, and Summary of Safety and Effectiveness for EverFlex Self-Expanding Peripheral Stent System (P110023).

PMA Final Decisions for January 2012

March 13, 2012 1:31 pm | by U.S. Food & Drug Administration | News | Comments

These are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions for January 2012.

Class I Medical Device Recall: Acclarent Inspira AIR Balloon Dilation System, size 18X40mm.

March 13, 2012 1:31 pm | by U.S. Food & Drug Administration | News | Comments

Reason for Recall: Acclarent identified the potential for the balloon to not deflate or to deflate slowly, which could result in airway obstruction until the balloon is deflated or removed. Prolonged obstruction of the airway may prevent adequate blood...

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