Libra Medical

Guidance for Industry Responding to Unsolicited Requests for Off-Label Information

dblaeser — Fri, 06 Jan 2012 17:04:58 +0000

This draft guidance is intended to describe the Food and Drug Administration’s (FDA or Agency) current thinking about how manufacturers and distributors (firms) of prescription human and animal drug products (drugs) and medical devices (devices) can respond to unsolicited requests for information about unapproved or uncleared indications or conditions of use (off-label information) related to their FDA-approved or cleared products. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM285145.pdf

Draft Guidance – CDRH Appeals Processes

dblaeser — Fri, 06 Jan 2012 16:50:36 +0000

Individuals outside of FDA who disagree with a decision or action taken by CDRH and wish to have it reviewed or reconsidered have several processes for resolution from which to choose, including: requests for supervisory review of an action; petitions; and hearings. These processes are broadly described in FDA regulations. This draft document provides general information about each process, as well as guidance on how to submit related requests to CDRH and FDA. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm284651.htm#1

The New 510(k) Paradigm – Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications – Final Guidance

dblaeser — Wed, 04 Jan 2012 17:00:07 +0000

This document provides guidance to the regulated industry and reviewers on two alternative approaches that may be used, under appropriate circumstances, to demonstrate substantial equivalence. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080187.htm

Draft Guidance – Medical Device Classification Product Codes

dblaeser — Wed, 04 Jan 2012 16:55:56 +0000

The purpose of this guidance document is to educate regulated industry and FDA Staff on how, when and why to use classification product codes for medical devices regulated by the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER). http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm285317.htm?source=govdelivery

Brown on bill to streamline ‘de novo’ FDA reviews

dblaeser — Fri, 09 Dec 2011 14:27:49 +0000

Sen. Scott Brown (R-Mass.) wants the FDA to make it easier for medical device makers to get new, less risky devices through the federal watchdog agency. http://www.massdevice.com/news/update-brown-bill-streamline-de-novo-fda-reviews

FDA, med-tech leaders seek accord

dblaeser — Fri, 09 Dec 2011 14:22:59 +0000

The industry and the agency want ways to speed up development and approval of new devices without cutting corners on safety. http://www.startribune.com/business/135218348.html

Medtronic Wins FDA Panel Backing to Allow Defibrillators for More Patients

dblaeser — Fri, 09 Dec 2011 14:21:49 +0000

Medtronic Inc. (MDT), the world’s biggest maker of heart-rhythm devices, won the backing of an advisory panel to expand the use of defibrillators that synchronize the right and left chambers of the heart. http://www.bloomberg.com/news/2011-12-07/medtronic-wins-fda-panel-backing-to-allow-defibrillators-for-more-patients.html

Draft Guidance – In Vitro Companion Diagnostic Devices

dblaeser — Wed, 23 Nov 2011 15:41:06 +0000

This guidance is intended to assist (1) sponsors who are planning to develop a therapeutic product¹ that depends on the use of an in vitro companion diagnostic device (or test) for its safe and effective use and (2) sponsors planning to develop an in vitro companion diagnostic device that is intended to be used with a corresponding therapeutic product. http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm262292.htm

Former Synthes, Norian execs receive prison terms

dblaeser — Wed, 23 Nov 2011 15:09:52 +0000

Three former executives of devicemaker Synthes and subsidiary Norian were sentenced to prison for their roles in illegal clinical trials of a bone cement in spine surgeries, federal prosecutors in Philadelphia said. http://www.modernhealthcare.com/article/20111122/NEWS/311229961?AllowView=VW8xUmo5Q21TcWJOb1gzb0tNN3RLZ0h0MWg5SVgra3NZRzROR3l0WWRMZmFWZjhERWxiNUtpQzMyWmFxNVg0WUpicWc=&utm_source=newsletter&utm_medium=email&utm_campaign=am

New Stent Type Has Rare But Potentially Serious Problem, FDA Investigates

dblaeser — Mon, 21 Nov 2011 15:21:41 +0000

The FDA says it is working with drug-eluting stent makers to better understand what makes the devices shrink or become deformed on rare occasions. A drug-eluting stent is a scaffold placed into narrowed, diseased peripheral or coronary arteries; it releases a medication to block cell proliferation, which helps prevent eventual reclogging of the blood vessel. The DES (drug-eluting stent) is placed during an angioplasty procedure.
http://www.medicalnewstoday.com/articles/237999.php