for Journals by Title or ISSN
for Articles by Keywords
help
Followed Journals
Journal you Follow: 0
 
Sign Up to follow journals, search in your chosen journals and, optionally, receive Email Alerts when new issues of your Followed Jurnals are published.
Already have an account? Sign In to see the journals you follow.
The Silver Sheet
   Follow    
   Full-text available via subscription Subscription journal
     ISSN (Print) 1068-5324
     Published by Informa plc Homepage  [13 journals]
  • News In Brief
    • Abstract: Four lawmakers want to know if FDA is using draft guidance as policy; federal government opens investigation into Boston Scientific defibrillators; and more.
      PubDate: Mon, 19 May 2014 12:00:04 -040
       
  • From Suppliers To Sloppiness, Experts Offer 5 Theories Why Aging Devices
           Are Recalled Most
    • Abstract: A CDRH report recently showed that a majority of recalled devices are older, yet the center has provided little insight into how it came to its conclusion. FDA’s relative silence on the matter has left several industry insiders to deduce for themselves why aging product types struggle more with recalls than younger ones.
      PubDate: Mon, 19 May 2014 12:00:03 -040
       
  • FDA Close-Out Letters
    • Abstract: Four letters released by FDA from April 18 through May 19.
      PubDate: Mon, 19 May 2014 12:00:03 -040
       
  • FDA Warning Letters
    • Abstract: A statistical tool used by Teleflex for CAPA data trending is deemed inadequate; maker of water purification systems didn’t notify FDA of two recall events. Ten warning letters listed by FDA from April 18 through May 19.
      PubDate: Mon, 19 May 2014 12:00:00 -040
       
  • Device Recall ‘SWAT Teams’: A Primer
    • Abstract: Exclusive Online-Only Content >>> Abbott Labs’ medical director urges medical device manufacturers to use a small centralized team to tackle product recalls in this month’s “Compliance Corner.”
      PubDate: Wed, 30 Apr 2014 13:00:00 -040
       
  • FDA Warning Letters
    • Abstract: Hospira cited for QS reg violations; Dexcom failed to report MDRs to the agency in a timely fashion. Four warning letters listed by FDA from March 18 through April 17.
      PubDate: Thu, 17 Apr 2014 09:30:04 -040
       
  • ‘Paradoxical’ FDA Recalls Report Credits Industry
           Collaboration For Improved Quality, But Uncovers Troubling Data About
           Older Devices
    • Abstract: Medical devices on the market for more than five years are recalled more often than younger ones, according to a recent FDA 10-year retrospective report on corrections and removals. “There is an intuitive appeal to the argument that devices that come to the market in an early point in their lifespan – say, the first year – are more likely to be subject to recalls, but that is simply not true,” CDRH Office of Compliance Director Steven Silverman says. Other notable report findings: troubles with components and software are the leading causes for most recalls; problems with AEDs, ventilators and...
      PubDate: Thu, 17 Apr 2014 09:30:02 -040
       
  • FDA Eyes Inspectional Form Changes As SOP Troubles Top FDA-483 Citations
           In 2013
    • Abstract: The way inspectional observations are presented on FDA-483 forms might be modified under a new FDA pilot program. The goal is to help device companies prioritize corrective actions to avoid potentially serious quality system troubles.
      PubDate: Thu, 17 Apr 2014 09:30:01 -040
       
  • News In Brief
    • Abstract: China looks to implement Unique Device Identification system; IMDRF releases software guidance; and more.
      PubDate: Thu, 17 Apr 2014 09:30:01 -040
       
  • FDA Close-Out Letters
    • Abstract: Four letters released by FDA from March 18 through April 17.
      PubDate: Thu, 17 Apr 2014 09:30:00 -040
       
  • FDA Warning Letters
    • Abstract: No device quality-related warning letters were released by FDA from Feb. 25 through March 17.
      PubDate: Wed, 19 Mar 2014 12:56:42 -040
       
  • News In Brief
    • Abstract: Fiscal year ’15 budget request boosts funding thanks to user fees; FDA schedules open meeting for its Case for Quality initiative; and more.
      PubDate: Wed, 19 Mar 2014 12:00:07 -040
       
  • Warning Letter Author Answers 9 Questions
    • Abstract: An FDA district office compliance officer explains her role in crafting warning letters and offers advice to manufacturers as they draft responses to the agency – among other issues – in this month’s “Compliance Corner.”
      PubDate: Wed, 19 Mar 2014 12:00:06 -040
       
  • FDA Close-Out Letters
    • Abstract: Four letters released by FDA from Feb. 25 through March 17.
      PubDate: Wed, 19 Mar 2014 12:00:06 -040
       
  • Got A Warning Letter' 4 Tips For Digging Out
    • Abstract: Michael Neaves, director of regulatory compliance services & senior quality engineer for consulting firm BioTeknica, offers four nuggets of advice to firms on what to do after receiving a warning letter: Make tough decisions. “The decisions that management needs to make when you’re looking at remediating your quality system is not so much what you’re going to do, but what you’re not going to do. Let’s face it: Everybody was busy before this warning letter came up and the need to remediate your quality system came up.
      PubDate: Wed, 19 Mar 2014 12:00:04 -040
       
  • Analysis: Foreign Firms Hit With Majority Of FDA Quality-Linked Warning
           Letters Last Year
    • Abstract: Most of the 150 warning letters issued by FDA last year were sent to foreign manufacturers, a “Silver Sheet” analysis shows. That letters to overseas companies have outpaced those to domestic ones is a surprise given that the agency performs nearly four times as many inspections of U.S.-based facilities each year.
      PubDate: Wed, 19 Mar 2014 12:00:04 -040
       
  • FDA 2013 Medical Device Quality-Related Warning Letters
    • Abstract: Complete list of 76 foreign and 74 domestic device quality-related warning letters released by the agency last year.
      PubDate: Wed, 19 Mar 2014 12:00:02 -040
       
  • 2013 Medical Device Recalls
    • Abstract: Complete list of recalls from calendar year 2013 includes 64 class I (6%), 1,008 class II (88%) and 66 class III (6%) medical device events.
      PubDate: Mon, 24 Feb 2014 12:28:00 -050
       
  • FDA Blames Over-Reporting For Record-High Recall Count In 2013; Looks To
           Root Causes
    • Abstract: The number of medical device recalls initiated by manufacturers last year hit an all-time high, according to an analysis by “The Silver Sheet.” FDA says the increase resulted in part from over-reporting of recalls by wary firms that were dinged in the past by the agency for not reporting. “Once a firm has been cited by an investigator, it is a wonderful reporter of recalls after that,” FDA official Ann Ferriter said in an interview. “They report a disproportionate number of recalls.” Meanwhile, the agency looks to root causes for answers. Failing to conduct thorough root cause investigations “...
      PubDate: Mon, 24 Feb 2014 12:00:04 -050
       
  • Recall Odds & Ends: 6 Expert Tips
    • Abstract: This month’s “Compliance Corner” highlights product recall tips from experts at device manufacturers Cordis, SpineFrontier and Philips Healthcare.
      PubDate: Mon, 24 Feb 2014 12:00:03 -050
       
  • News In Brief
    • Abstract: FDA finally releases rule requiring electronic Medical Device Reporting; eReporting initiative for recalls struggles; and more.
      PubDate: Mon, 24 Feb 2014 12:00:02 -050
       
  • Device Center Recall Chief Talks Health Hazard Evaluations
    • Abstract: A health hazard evaluation is used to determine the risk that a recalled product poses. A manufacturer’s HHE, along with an HHE performed by FDA, helps establish the classification of a recall.
      PubDate: Mon, 24 Feb 2014 12:00:02 -050
       
  • FDA Close-Out Letters
    • Abstract: Eight letters released by FDA from Jan. 14 through Feb. 24.
      PubDate: Mon, 24 Feb 2014 12:00:01 -050
       
  • 10 Most Frequently Recalled Device Types
    • Abstract: FDA shares its list of products recalled most by firms over the past five years.
      PubDate: Mon, 24 Feb 2014 12:00:01 -050
       
  • FDA Warning Letters
    • Abstract: Two separate Baxter manufacturing facilities cited for quality system troubles. Ten warning letters listed by FDA from Jan. 14 through Feb. 24.
      PubDate: Mon, 24 Feb 2014 12:00:00 -050
       
 
 
JournalTOCs
School of Mathematical and Computer Sciences
Heriot-Watt University
Edinburgh, EH14 4AS, UK
Email: journaltocs@hw.ac.uk
Tel: +00 44 (0)131 4513762
Fax: +00 44 (0)131 4513327
 
About JournalTOCs
API
Help
News (blog, publications)
JournalTOCs on Twitter   JournalTOCs on Facebook

JournalTOCs © 2009-2014