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Federal Register: Medical Devices: Safety and Effectiveness Summaries for Premarket Approval Applications; Availability(2)

November 26, 2010 2:31 am | by U.S. Food & Drug Administration | News | Comments

The Food and Drug Administration (FDA) is publishing a list of premarket approval applications (PMAs) that have been approved. This list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMAs through th

510(k) Final Decisions - October 2010

November 24, 2010 7:30 am | by U.S. Food & Drug Administration | News | Comments

Page Last Updated: 11/24/2010 Note: If you need help accessing information in different file formats, see Instructions for Downlo

Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request; Reports of Corrections and Removals(2)

November 23, 2010 4:31 am | by U.S. Food & Drug Administration | News | Comments

The FDA is announcing an opportunity for public comment on the proposed collection of certain information by the Agency.

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Propoxyphene: Withdrawal - Risk of Cardiac Toxicity(2)

November 19, 2010 8:31 am | by U.S. Food & Drug Administration | News | Comments

New data shows that Propoxyphene and Propoxyphene-containing products can cause serious toxicity to the heart, even when used at therapeutic doses.

CDRH Learn (New Courses Available in English, Spanish, and Chinese)

November 19, 2010 5:31 am | by U.S. Food & Drug Administration | News | Comments

CDRH Learn is our latest innovative educational tool. It consists of a series of training modules describing many aspects of medical device and radiological health regulation, covering both premarket and postmarket issues...

Needleless Pre-filled Glass Syringes: Stakeholder Advisory - Compatibility Problems with Needleless Intravenous Access Systems

November 18, 2010 7:31 am | by U.S. Food & Drug Administration | News | Comments

Syringes may malfunction, break, or become clogged during the process of attempting to connect to some needleless IV access systems.

Federal Register: Medical Devices; General and Plastic Surgery Devices; Classification of Non-Powered Suction Apparatus Device Intended for Negative Pressure Wound Therapy

November 17, 2010 4:31 am | by U.S. Food & Drug Administration | News | Comments

The agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is publishing a notice of availability for...

Federal Register: Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Non-Powered Suction Apparatus Device Intended for ...

November 17, 2010 4:31 am | by U.S. Food & Drug Administration | News | Comments

This guidance document describes a means by which non-powered suction apparatus devices intended for NPWT may comply with the requirement of special controls for class II devices. Elsewhere in this issue of the Federal Register, FDA is publishing a...

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Federal Register: Guidance for Industry, Mammography Quality Standards Act Inspectors, and Food and Drug Administration Staff; The Mammography Quality Standards Act Final Regu...

November 16, 2010 8:31 am | by U.S. Food & Drug Administration | News | Comments

This document is intended to assist mammography facilities and their personnel in meeting the requirements of the Mammography Quality Standards Act (MQSA) regulations.

Federal Register: External Defibrillators; Public Workshop

November 16, 2010 8:31 am | by U.S. Food & Drug Administration | News | Comments

The purpose of the public workshop is to share FDA's understanding of the risks and benefits of external defibrillators, to clarify FDA's current expectations for how industry should identify, report, and take action on problems observed with these...

Letter to Manufacturers of External Defibrillators About Developing Safer Products

November 15, 2010 4:31 am | by U.S. Food & Drug Administration | News | Comments

The FDA is notifying you of our concerns relating to serious adverse events noted in Medical Device Reports (MDRs) associated with the use of external defibrillators and a large number of recalls of external defibrillators. As a result, FDA may, in the...

FDA Public Workshop on External Defibrillators, December 15-16, 2010(2)

November 15, 2010 4:31 am | by U.S. Food & Drug Administration | News | Comments

The FDA is holding a public workshop to share FDA?s understanding of the risks and benefits of external defibrillators, to clarify FDA?s current expectations for how industry should identify, report, and take action on problems observed with these devices

Sigma Spectrum Infusion Pump Model 35700: Class 1 Recall: Risk of Over-Infusion

November 14, 2010 6:30 am | by U.S. Food & Drug Administration | News | Comments

Unit may fail suddenly, causing inaccurate flow,back flow,over-infusion, and free flow. Pump does not issue an alarm when this occurs and could result in serious injury or death.

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Skin Closure System Reclassified, Special Controls Guidance Issued

November 12, 2010 4:32 pm | by U.S. Food & Drug Administration | News | Comments

Closure Medical may soon have more competition for its Prineo skin closure system now that the FDA has downgraded tissue adhesive with adjunct wound closure devices from Class III to Class II.

FDA, Health Canada to Pursue Joint Third-Party Inspections(2)

November 12, 2010 4:32 pm | by U.S. Food & Drug Administration | News | Comments

Giving devicemakers two inspections for the price of one, the FDA and Health Canada (HC) have agreed to move forward with a joint third-party inspection program.

Federal Register: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Medical Devices; Device Tracking

November 12, 2010 3:31 am | by U.S. Food & Drug Administration | News | Comments

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish

VITEK 2 Gram Negative Susceptibility Cards Containing Piperacillin/Tazobactam (TZP): Recall - Incorrect Test Results Observed

November 10, 2010 6:30 am | by U.S. Food & Drug Administration | News | Comments

Incorrect results could potentially lead to patients being inappropriately treated with Piperacillin/Tazobactam, which could cause serious injury or death.

Federal Register: Medical Devices; General and Plastic Surgery Devices; Classification of Tissue Adhesive With Adjunct Wound Closure Device Intended for Topical Approximation ...

November 10, 2010 5:31 am | by U.S. Food & Drug Administration | News | Comments

The FDA is classifying the tissue adhesive with adjunct wound closure device intended for topical approximation into class II (special controls).

Federal Register: Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Tissue Adhesive With Adjunct Wound Closure Device ...

November 10, 2010 5:30 am | by U.S. Food & Drug Administration | News | Comments

This guidance document describes a means by which tissue adhesives with adjunct wound closure devices intended for the topical approximation of skin may comply with the requirement of special controls for class II devices.

Safety Investigation of CT Brain Perfusion Scans: Update 11/9/2010

November 9, 2010 4:31 am | by U.S. Food & Drug Administration | News | Comments

The FDA is issuing this update to inform you of the findings of its investigation of the manufacturers of CT scanners that were the subject of the earlier communications as well as updated recommendations. In addition, this communication summarizes the...

Triton Pole Mount Infusion Pump by WalkMed: Recall - Potential Door Open Alarm Problem

November 8, 2010 5:30 am | by U.S. Food & Drug Administration | News | Comments

The recalled pumps have been found to possibly have a problem with the pump door open alarm, which potentially could result in over infusion of medication.

CareFusion & #8217;s Antitrust Lawsuit Against Medtronic Is Dismissed

November 5, 2010 2:31 pm | by U.S. Food & Drug Administration | News | Comments

CareFusion failed to prove that Medtronic sought to illegally dominate the vertebroplasty and kyphoplasty markets, a federal district judge has ruled.

Roche, Stanford Patent Case Heads to US Supreme Court

November 5, 2010 2:31 pm | by U.S. Food & Drug Administration | News | Comments

A popular source for innovative new medical products could dry up, should the U.S. Supreme Court overturn a lower court’s ruling on a case involving Roche Molecular System and Stanford University.

Duro Extend Capsules for Men: Recall - Undeclared Drug Ingredient

November 5, 2010 9:30 am | by U.S. Food & Drug Administration | News | Comments

Product marketed as dietary supplement contains undeclared Sulfoaidenafil, which may interact with nitrates found in some prescription drugs and lower blood pressure to dangerous levels.

Information on Security Screening of People

November 4, 2010 9:30 am | by U.S. Food & Drug Administration | News | Comments

People screening is the practice of searching people before allowing access to a secure area, for example at airports, court houses, prisons, or museums. People screening electronic products are used to detect concealed weapons, explosives or other...

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