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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).

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Draft Guidance for Industry and Food and Drug Administration Staff - Class II Special Controls Guidance Document: Nucleic Acid-Based In Vitro Diagnostic Devices for the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

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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...

Acclarent Inspira AIR Balloon Dilation System: Class 1 Recall - Potential For Balloon To Not Deflate Or To Deflate To Slowly

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

Prolonged obstruction of the airway may prevent adequate blood oxygenation, which could cause temporary or permanent impairment to the patient

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Synthes Slapped With Wrongful Deaths Suit, FDA Warning Letter

March 9, 2012 1:31 pm | by U.S. Food & Drug Administration | News | Comments

Swiss devicemaker Synthes faces trouble from two sides, with an FDA warning letter posted just days after the company was sued by the families of two patients who died on the operating table during illegal clinical trials.

OIG Finds No Basis to Prosecute & #8216;FDA Nine & #8217; Over Personal Emails

March 9, 2012 1:31 pm | by U.S. Food & Drug Administration | News | Comments

After consulting with Justice Department prosecutors, the HHS Office of Inspector General (OIG) has found nothing to substantiate the FDA’s claim that it began monitoring nine employees’ emails only after hearing that confidential industry information had been leaked to the...

Gerber Good Start Gentle Powdered Infant Formula: Recall - Off-Odor

March 9, 2012 8:30 am | by U.S. Food & Drug Administration | News | Comments

Reports of gastrointestinal complaints.

Guidance for Industry and Food and Drug Administration Staff - Class II Special Controls Guidance Document: Norovirus Serological Reagents

March 8, 2012 5:30 am | by U.S. Food & Drug Administration | News | Comments

This special controls guidance document was developed to support the classification into class II (special controls) of norovirus serological reagents. These devices detect norovirus antigens in human fecal specimens as an aid in the diagnosis of...

Summary Information for: ION? Paclitaxel-Eluting Coronary Stent System (Monorail and Over-the-Wire Delivery Systems)

March 7, 2012 6:30 am | by U.S. Food & Drug Administration | News | Comments

Labeling, Approval Order, and Summary of Safety and Effectiveness for ION? Paclitaxel-Eluting Coronary Stent System (Monorail and Over-the-Wire Delivery Systems) (P100023S015).

Summary Information for: Resolute MicroTrac Zotarolimus-Eluting Coronary Stent System (Resolute MicroTrac) and Resolute Integrity Zotarolimus-Eluting Coronary Stent System (Re...

March 7, 2012 4:30 am | by U.S. Food & Drug Administration | News | Comments

Labeling, Approval Order, and Summary of Safety and Effectiveness for Resolute MicroTrac Zotarolimus-Eluting Coronary Stent System (Resolute MicroTrac) and Resolute Integrity Zotarolimus-Eluting Coronary Stent System (Resolute Integrity) (P110013).

Consumer Information on: Breast Companion & #xae; Software System - P100007

March 6, 2012 7:32 am | by U.S. Food & Drug Administration | News | Comments

The Breast Companion® Software System is a computer-aided report-generating system intended to improve the ACR BI-RADS® (American College of Radiology, Breast Imaging Reporting and Data System) assessment of ultrasound images of lesions of the...

Summary Information for: Breast Companion & #xae; Software System

March 6, 2012 7:32 am | by U.S. Food & Drug Administration | News | Comments

Labeling, Approval Order, and Summary of Safety and Effectiveness for Breast Companion® Software System (P100007).

Houston Medical Robotics, Inc. Receives FDA 510(k) Clearance for Euclid Tier 1 Mini Access System

March 6, 2012 4:48 am | News | Comments

Houston Medical Robotics, Inc. announces that it has received U.S. Food and Drug Administration 510(k) clearance to market the Euclidâ„¢ Tier 1 Mini Access System. The Euclidâ„¢ Tier 1 Mini Access System is a portable, hand-held device that integrates commercially available...

Summary Information for: Ovation Abdominal Stent Graft System

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

Labeling, Approval Order, and Summary of Safety and Effectiveness for Ovation Abdominal Stent Graft System (H100008).

Consumer Information on: OVATION Abdominal Stent Graft System - H100008

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

The OVATION abdominal stent graft system is used to treat abdominal aortic aneurysms during endovascular repair (EVAR). An aneurysm is a diseased, bulging, weak section of an artery wall; in this case the aorta. The main portion of the OVATION abdominal..

Cardiac Science Powerheart, CardioVive, CardioLife; GE Responder and Responder Pro; and Nihon-Kohden Automated External Defibrillators (AEDs): Class I Recall - Defective Compo...

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

Unexpected component failure may lead to AEDs not delivering defibrillation therapy, causing serious adverse health consequences, including death.

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