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The Silver Sheet
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     ISSN (Print) 1068-5324
     Published by Informa plc Homepage  [13 journals]
  • GUEST COLUMN: New AdvaMed ‘Library Of Successful Quality
           Practices’
    • Abstract: Online-Only Content >>> AdvaMed’s Sharon Segal introduces the device industry group’s new “Library of Successful Quality Practices,” a resource for manufacturers to enhance their own quality processes.
      PubDate: Thu, 16 Oct 2014 12:50:01 -040
       
  • Class III Device Recalls An Afterthought' Not So Fast . . .
    • Abstract: Low-risk class III medical device recalls sometimes fade into the background because they comprise only a sliver of the overall corrections and removals in a given year. Nevertheless, manufacturers should be aware that any decisions they make regarding class III actions are still going to receive FDA attention.
      PubDate: Tue, 14 Oct 2014 15:00:06 -040
       
  • Warning Letter Roundup & Recap
    • Abstract: Zoll cited for QS and MDR violations; FDA instructs maker of drug-of-abuse kits to hire a consultant to audit the firm’s manufacturing and quality assurance systems; Ambco Electronics failed to fully investigate and document device failures. Eight quality-related warning letters were listed by FDA from Sept. 12 through Oct. 14.
      PubDate: Tue, 14 Oct 2014 15:00:05 -040
       
  • Specialized Device Inspectorate Part Of Joint CDRH/ORA Action Plan
    • Abstract: FDA’s Office of Regulatory Affairs will establish a specialized unit of device-focused field investigators according to a 2015 CDRH/ORA program alignment action plan posted online Oct. 7. Under the announced steps, CDRH will work with ORA throughout the current fiscal year to develop a plan for establishing a medical device inspectorate and a separate mammography quality inspectorate.
      PubDate: Tue, 14 Oct 2014 15:00:04 -040
       
  • IMDRF’s Final Software Framework Released
    • Abstract: The International Medical Device Regulators Forum has released a final version of a risk-based framework for software that act as medical devices.
      PubDate: Tue, 14 Oct 2014 15:00:03 -040
       
  • FDA ‘Data Dashboard’ Offers Insight Into Industry Trends
    • Abstract: The new online tool will help assist in analyzing cross-agency inspection, warning letter, enforcement and recall data, the agency says. The dashboard is part of FDA’s ongoing Transparency Initiative.
      PubDate: Tue, 14 Oct 2014 15:00:03 -040
       
  • Odds & Ends
    • Abstract: Specialized device inspectorate part of joint CDRH/ORA action plan A specialized unit of device-focused field investigators will be established according to a CDRH/ORA program alignment action plan posted online Oct. 7. Under the announced steps, CDRH will work with ORA throughout the current 2015 fiscal year to develop a plan for establishing a medical device inspectorate and a separate mammography quality inspectorate.
      PubDate: Tue, 14 Oct 2014 15:00:02 -040
       
  • Recent Warning Letter Close-Outs
    • Abstract: Three quality-related FDA close-out letters were released from Sept. 12 through Oct. 14.
      PubDate: Tue, 14 Oct 2014 15:00:00 -040
       
  • PODCAST: QSIT Team Leader Tim Wells On Using The Inspectional Approach As
           A Learning Tool
    • Abstract: Online-Only Content >>> The coauthor of FDA’s 15-year-old Quality System Inspection Technique, Tim Wells, explains how firms can use QSIT as a learning tool in this “Silver Sheet” podcast.
      PubDate: Tue, 14 Oct 2014 15:00:00 -040
       
  • FDA Releases 2013 Quality System Data; Points Finger At Device History
           Records
    • Abstract: Exclusive Online-Only Content >>> Troubles with device history records are noted as a significant issue in 2013 quality system data released by FDA’s device center. But aside from DHR concerns, there weren’t many other surprises offered by the data.
      PubDate: Mon, 29 Sep 2014 15:50:00 -040
       
  • GUEST COLUMN: Bulletproofing The CAPA Process
    • Abstract: Exclusive Online-Only Content >>> FDA compliance expert John Avellanet takes a look at some of the reasons why corrective and preventive action – CAPA – continues to be a top observation noted in FDA-483 inspection forms and agency warning letters. “An effective, compliant CAPA process produces clear objective evidence easily reviewed by an FDA investigator, ISO auditor or even a product liability litigator,” Avellanet writes.
      PubDate: Fri, 19 Sep 2014 11:45:03 -040
       
  • UDI System Faces Major Test As Manufacturers Work To Meet FDA’s
           Class III Device Deadline
    • Abstract: Manufacturers of high-risk medical devices are staring down the barrel of a Sept. 24 deadline to comply with FDA’s UDI system. Anita Rayner of CDRH’s Office of Surveillance and Biometrics says “industry is making a great effort not only to comply, but to provide us with constructive feedback,” yet some industry experts say there are firms still struggling to determine the type of product data they need to feed into the agency’s Global Unique Device Identification Database. “Collecting data attributes is the hardest part of implementing UDI, by far,” says UDI expert Jay Crowley.
      PubDate: Thu, 11 Sep 2014 13:00:15 -040
       
  • St. Jude Medical Resolves Neuromod Warning Letter
    • Abstract: St. Jude Medical has been told by FDA that a 2009 warning letter targeting the firm’s Plano, Texas, neuromodulation device facility has been resolved.
      PubDate: Thu, 11 Sep 2014 13:00:11 -040
       
  • Senators Urge Withdrawal Of Power Morcellators
    • Abstract: FDA should ask manufacturers to stop selling laparoscopic power morcellators used for uterine tissue or fibroid removal, two senators wrote in an Aug. 19 letter to the agency.
      PubDate: Thu, 11 Sep 2014 13:00:09 -040
       
  • Warning Letter Roundup & Recap
    • Abstract: SmartMonitor battery pack troubles dog Philips Children’s Medical Ventures; maker of GenStrip glucose test strips cited for QS and MDR reg violations; the Portable Exchange Deionization System was labeled to meet the requirements of an outdated ANSI/AAMI standard. Nine quality-related warning letters were listed by FDA from Aug. 12 through Sept. 11.
      PubDate: Thu, 11 Sep 2014 13:00:07 -040
       
  • Recent Warning Letter Close-Outs
    • Abstract: Six quality-related FDA close-out letters were released from Aug. 12 through Sept. 11.
      PubDate: Thu, 11 Sep 2014 13:00:07 -040
       
  • GUDID Data Attributes
    • Abstract: Below is an overview of information that FDA is requesting for its UDI database. A more detailed spreadsheet of these data elements can be found on FDA’s website.
      PubDate: Thu, 11 Sep 2014 13:00:06 -040
       
  • ODE Chief Departs
    • Abstract: Christy Foreman left her post as director of CDRH’s Office of Device Evaluation for a position in FDA’s Center for Tobacco Products on Sept. 7.
      PubDate: Thu, 11 Sep 2014 13:00:05 -040
       
  • DePuy Synthes Jaw Device Recall
    • Abstract: DePuy Synthes’ mid-April recall of its Craniomaxillofacial Distraction System was designated class I by FDA in an Aug. 26 notice.
      PubDate: Thu, 11 Sep 2014 13:00:05 -040
       
  • Report: Registries Can Help With Post-Market Surveillance
    • Abstract: Researchers argue that the U.S. needs a stronger system of registries to answer safety and effectiveness questions that can’t be addressed by size-limited pre-market studies.
      PubDate: Thu, 11 Sep 2014 13:00:04 -040
       
  • Odds & Ends
    • Abstract: Report: Registries can help with post-market surveillance Registries are not for every device, but when they are warranted, they should be tightly focused and very transparent. That’s according to Sept. 3 recommendations from groups closely engaged in FDA’s efforts to upgrade the U.S. post-market device surveillance system.
      PubDate: Thu, 11 Sep 2014 13:00:01 -040
       
  • PODCAST: UDI Architect Jay Crowley Offers Device Manufacturers Last-Minute
           Advice
    • Abstract: Exclusive Online-Only Content >>> “Mr. UDI” Jay Crowley shares eleventh-hour Unique Device Identification tips in this “Silver Sheet” podcast.
      PubDate: Thu, 11 Sep 2014 13:00:00 -040
       
  • GUEST COLUMN: The Latest On Medical Device Supply Chain Accreditation
    • Abstract: Exclusive Online-Only Content >>> Philips Healthcare’s Ravi Nabar provides an update on MedAccred, the Performance Review Institute’s upcoming program to improve medical device supply chain quality and visibility.
      PubDate: Fri, 05 Sep 2014 11:00:00 -040
       
  • CDRH Recall Chief On Social Media Notifications And Conducting Recall
           ‘Post-Mortems’
    • Abstract: Exclusive Online-Only Content >>> Although FDA is slightly behind the times when it comes to developing a policy for electronic and social media recall communications, CDRH Recall Branch Chief Ron Brown provides some tips on the topic. Also discussed: whether manufacturers should dissect a closed recall by using a “post-mortem” approach.
      PubDate: Fri, 29 Aug 2014 13:00:01 -040
       
  • PODCAST: 5 Pieces Of CAPA Advice From Cap Uldriks
    • Abstract: Exclusive Online-Only Content >>> Corrective and preventive action, or CAPA, can be tricky for many device manufacturers to master. In this inaugural “Silver Sheet” podcast, Cap Uldriks – a compliance expert who spent 32 years in FDA’s device center – offers recommendations to ensure a healthy, smooth CAPA program.
      PubDate: Wed, 20 Aug 2014 14:10:00 -040
       
 
 
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