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The Silver Sheet
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     ISSN (Print) 1068-5324
     Published by Informa plc Homepage  [13 journals]
  • 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
       
  • CDRH Urges Firms To Close Loop On CAPAs, Create Filters To Weed Out Poor
           Quality Data
    • Abstract: Applying a closed-loop approach to corrective and preventive action activities is one of the best ways to ensure device quality and gather useful data, FDA says. Manufacturers often fail to ensure that they complete the CAPA loop, leading to corrective and preventive actions that might be open for years, or product fixes that don’t work and complicate matters further by presenting the firms with a whole new set of challenges.
      PubDate: Wed, 13 Aug 2014 14:00:07 -040
       
  • UDIs Needed On Insurance Forms For Sentinel Initiative, Pew Expert Says
    • Abstract: Two years after Congress mandated that the Sentinel initiative be expanded to cover devices, there are still technical barriers to making that happen.
      PubDate: Wed, 13 Aug 2014 14:00:06 -040
       
  • China FDA Poised To Issue Supplementary Regulations
    • Abstract: More than 10 regulations pending from China FDA will target most aspects of a device’s lifecycle, ranging from clinical study requirements, regulatory approval, manufacturing and quality assurance, through to post-market surveillance.
      PubDate: Wed, 13 Aug 2014 14:00:06 -040
       
  • CDRH Looks To Industry For Staff Training
    • Abstract: FDA’s device center is looking for volunteers from device manufacturers and other organizations to help train its staff in one of eight foundational topics for product development and manufacturing.
      PubDate: Wed, 13 Aug 2014 14:00:06 -040
       
  • Home-Use Device Guidance Finalized
    • Abstract: FDA finalizes its guidance on designing devices for use outside the health care setting.
      PubDate: Wed, 13 Aug 2014 14:00:05 -040
       
  • Recent Warning Letter Close-Outs
    • Abstract: Two quality-related FDA close-out letters were released from July 8 through Aug. 11.
      PubDate: Wed, 13 Aug 2014 14:00:04 -040
       
  • Warning Letter Roundup & Recap
    • Abstract: CAPA procedures weren’t established and maintained at device-makers Smith & Nephew, GaleMed and MedMizer; CareFusion’s spec developer/complaint handler didn’t investigate complaints or implement MDR procedures. Eight quality-related warning letters were listed by FDA from July 8 through Aug. 11.
      PubDate: Wed, 13 Aug 2014 14:00:03 -040
       
  • Odds & Ends
    • Abstract: Home-use device guidance finalized FDA finalized guidance on designing devices for use outside of health care facilities, sticking closely with its 2012 proposal on the topic. The agency’s guidance on “Design Considerations for Devices Intended for Home Use” addresses the growing trend of device use outside of health care facilities, especially devices that patients use at home. (See "Home Devices: FDA Guidance Pushes Firms To ‘Design Out’ Risks, Employ Usability" — "The Silver Sheet," January 2013.) The guidance, posted online Aug. 4, has a strong focus on environmental and end-user...
      PubDate: Wed, 13 Aug 2014 14:00:02 -040
       
  • Eli Lilly Uses Device Safety Team For Risk Management Planning
    • Abstract: Exclusive Online-Only Content >>> Eli Lilly’s global quality leader for devices provides a peek into how the company kick-starts its risk management planning, including identifying possible hazards to product users.
      PubDate: Mon, 04 Aug 2014 13:45:00 -040
       
  • 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
       
 
 
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