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The Silver Sheet
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     ISSN (Print) 1068-5324
     Published by Informa plc Homepage  [13 journals]
  • 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
  • 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
  • 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for QS and MDR reg violations; the Portable Exchange Deionization System was labeled to meet the requirements of an outdated ANSI/AAMI standard.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
  • 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
    • 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
    • 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
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