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The Silver Sheet
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   Full-text available via subscription Subscription journal
     ISSN (Print) 1068-5324
     Published by Informa plc Homepage  [13 journals]
  • FDA Tips On MDRs, Complaints, Other Hot Topics
    • Abstract: Exclusive Online-Only Content >>> Complaints, Medical Device Reporting and CAPA are among top issues discussed by veteran FDA staff. Part 3 of 3.
      PubDate: Tue, 29 Jul 2014 14:00:00 -040
       
  • Warning Letter Roundup & Recap
    • Abstract: Staar Surgical faces quality system violations related to its Visian ICL and MICL intraocular lenses; MTI Precision Products didn’t notify FDA after it recalled TM20 hand pieces due to sharp nose edges; an employee responsible for elastic band production at Dexta Corp. was unable to answer questions about his job. Eight quality-related warning letters were listed by FDA from June 24 through July 7.
      PubDate: Wed, 09 Jul 2014 14:00:22 -040
       
  • Medtronic Recall Designated Class I
    • Abstract: The device is used to externally drain and monitor cerebrospinal fluid and to monitor intracranial pressure (ICP).
      PubDate: Wed, 09 Jul 2014 14:00:18 -040
       
  • IMDRF Coming To D.C. In September
    • Abstract: The group will convene in Washington, D.C., on Sept. 15-19, including a plenary IMDRF stakeholder meeting on Sept. 17.
      PubDate: Wed, 09 Jul 2014 14:00:16 -040
       
  • St. Jude Warning Letter Resolved; Close-Out Letter Issued
    • Abstract: FDA has formally closed the January 2013 warning letter for St. Jude Medical’s Sylmar, Calif., cardiac rhythm management device manufacturing facility.
      PubDate: Wed, 09 Jul 2014 14:00:12 -040
       
  • UDI Database Guidance Finally Finalized
    • Abstract: FDA issued a fully finalized guidance document for its Global Unique Device Identification Database on June 25. It is an update from a version released June 11.
      PubDate: Wed, 09 Jul 2014 14:00:09 -040
       
  • FDA Calls Out Quality, Safety, Post-Market Surveillance In Five-Year
           Strategy
    • Abstract: Senior management fully committed to excellence, proper management of supply chains, and the continuous and proactive use of risk management are three key ways device manufacturers can ensure better product quality, a proposed FDA strategic priorities plan says.
      PubDate: Wed, 09 Jul 2014 14:00:05 -040
       
  • Recent Warning Letter Close-Outs
    • Abstract: Three quality-related FDA close-out letters were released from June 24 through July 7.
      PubDate: Wed, 09 Jul 2014 14:00:04 -040
       
  • FDA’s Device Center Looks To Risk Management As It Pens
           Quality-Related Inspectional Guidance
    • Abstract: Ensuring that a good risk management program is in place is more important than ever now that CDRH plans to rely on the concept to inform new inspectional guidelines for FDA investigators. Using risk management information, the center hopes to be better poised to identify device-specific points that should be looked at closely during an agency audit to ensure quality.
      PubDate: Wed, 09 Jul 2014 14:00:02 -040
       
  • Odds & Ends
    • Abstract: FDA calls out quality, safety, post-market surveillance in five-year strategy Senior management fully committed to excellence, proper management of supply chains, and the continuous and proactive use of risk management are three key ways device manufacturers can ensure better product quality, according to a proposed five-year FDA strategic priorities plan. The document, released June 30, also urges firms to have clear and in-depth knowledge of their products, as well as continuous and consistent monitoring of quality management systems and processes. “Medical product quality problems...
      PubDate: Wed, 09 Jul 2014 14:00:00 -040
       
  • 6 More Inspectional Insights From FDA Experts
    • Abstract: Exclusive Online-Only Content >>> FDA Cincinnati district office compliance officer – and warning letter author – Gina Brackett joins agency investigators Laureen Geniusz and Ben Dastoli in offering device-makers inspectional tips and advice. “I’m the guy who inspects your garbage cans to see what you threw away,” Dastoli says. Part 2 of 3.
      PubDate: Tue, 01 Jul 2014 15:30:00 -040
       
  • BONUS: 33 Survey Responses On Gaining Compliance Buy-In
    • Abstract: Exclusive Online-Only Content >>> Results from a recent industry survey illustrated that it can be tricky for QA/RA officials to obtain buy-in for compliance activities from colleagues working in other manufacturing areas. Thirty-three anonymous survey-takers offer insights and tips for making quality and regulatory true business partners in the device-making process while other posters appeared to be frustrated, including one clearly irritated respondent who lamented about “getting ‘caught’ and hearing/reading firsthand from FDA or other competent authorities that the regulatory pers...
      PubDate: Tue, 01 Jul 2014 11:20:03 -040
       
  • Enforcement Discretion For MDDS, FDA Draft Guidance Says
    • Abstract: Three years after establishing a class I regulatory policy for software that passively stores, transfers, formats or displays medical device data, FDA has finally said enough is enough.
      PubDate: Mon, 23 Jun 2014 15:00:06 -040
       
  • FDA Draft Guidance Tackles Internet Misinformation
    • Abstract: Device manufacturers looking to correct misinformation posted on third-party social media sites about their products should correct all of the information within a defined area of the forum, including exaggerated efficacy claims, FDA says.
      PubDate: Mon, 23 Jun 2014 15:00:06 -040
       
  • Industry Questions FDA On Draft Guidance Overreach
    • Abstract: Device industry representatives pressed CDRH at a recent public meeting to better manage draft guidance documents to ensure they don’t remain in an unresolved state for an unusually long time.
      PubDate: Mon, 23 Jun 2014 15:00:05 -040
       
  • GUDID Guidance Finalized – Sort Of
    • Abstract: In an unusual move, FDA finalized portions of the guidance for its Unique Device Identification database while maintaining draft status for other parts.
      PubDate: Mon, 23 Jun 2014 15:00:04 -040
       
  • Odds & Ends
    • Abstract: FDA finalizes portions of its UDI database guidance while maintaining a draft status for other parts; industry questions agency over draft guidance overreach; and more.
      PubDate: Mon, 23 Jun 2014 15:00:04 -040
       
  • Survey: Quality/Regulatory Seen By Some As ‘Necessary Evil’
           And ‘Deterrent To Revenue’
    • Abstract: Upper management continues to hold a somewhat pessimistic view of QA/RA functions and activities, according to a recent industry survey. To combat that mentality, “you definitely have to be a partner, but you also have to establish a perception,” Abbott Laboratories’ Monica Wilkins says. “If you don’t take an active role to become a partner and demonstrate how you add value to the organization, then, yes, definitely you’ll be seen as a deterrent or another negative factor.” Further, in the anonymous survey of 385 individuals who work for device manufacturers, a combined 67 percent of responden...
      PubDate: Mon, 23 Jun 2014 15:00:03 -040
       
  • Recent Warning Letter Close-Outs
    • Abstract: Four quality-related FDA close-out letters released from May 20 through June 23.
      PubDate: Mon, 23 Jun 2014 15:00:03 -040
       
  • Warning Letter Roundup & Recap
    • Abstract: Steris Isomedix Services initiated nonconformance reports for three instances of employee data manipulation but failed to escalate the issue to a corporate-level CAPA; Instru-med’s complaint handling software wasn’t validated to prevent employees from deleting records. Fifteen quality-related warning letters listed by FDA from May 20 through June 23.
      PubDate: Mon, 23 Jun 2014 15:00:02 -040
       
  • FDA Investigators Offer 8 Inspectional Insights
    • Abstract: Exclusive Online-Only Content >>> FDA investigators Ben Dastoli and Laureen Geniusz offer expert tips on inspections to medical device manufacturers. Part 1 of 3.
      PubDate: Mon, 09 Jun 2014 15:25:00 -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
       
  • Lawmakers Want To Know If FDA Is Using Draft Guidance As Policy
    • Abstract: Four Republican senators are pressing FDA about charges from industry that the agency is using draft guidance documents to make substantive policy changes.
      PubDate: Mon, 19 May 2014 12:00:00 -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
       
 
 
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