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Journal Cover   The Silver Sheet
  [4 followers]  Follow
   Full-text available via subscription Subscription journal
   ISSN (Print) 1068-5324
   Published by Informa plc Homepage  [16 journals]
  • Pew Says Feds Should Create Standards, Require Unified UDI System
    • Abstract: Pew Charitable Trusts released a new report that outlines the benefits of Unique Device Identifiers and makes a case for federal agencies to develop standards, and require industry and providers to adopt UDIs.
      PubDate: Wed, 30 Sep 2015 17:20:00 -040
  • As Second Wave Of UDI Reg Hits, Manufacturers Should Take Closer Look At
    • Abstract: Although device accessories should include Unique Device Identifiers, some companies aren't sure which parts of a product are indeed accessories and which are simply spare parts, UDI guru Jay Crowley says. To solve this puzzle, he suggests that firms separate the items into two "buckets": one for accessories, which require a unique identifier, and one for other types of parts, which do not.
      PubDate: Thu, 24 Sep 2015 13:00:01 -040
  • Light At The End Of The Tunnel: Redo Of ISO 13485 Chugs Forward With Final
           Draft, But Could It Be Derailed By European 'No' Votes'
    • Abstract: The International Organization for Standardization is prepped to begin voting on the updated ISO 13485 early next year, but the co-convener of the work group revising the widely used international quality systems standard worries about some countries voting 'no' because the reworked ISO 13485 will not use ISO's so-called "high-level" document approach. In the end, "we've done as much as we can; if particular countries want to vote 'no' on the docket because of the high-level structure and vote no again on the FDIS final draft standard, then so be it," ISO TC210/Working Group 1 co-chair Ed Ki...
      PubDate: Thu, 24 Sep 2015 11:50:00 -040
  • Want A Quick Inspection' Have Records Prepped And Don't Dilly-Dally
           When Asked For Documents, FDA Investigators Advise
    • Abstract: When 86 percent of FDA domestic inspections are preannounced, it's difficult to imagine that manufacturers could be caught unprepared – yet many do not have the appropriate records ready for investigators when they knock on the front door. And an auditor's suspicion might be aroused when it takes a long time to retrieve a particular document, says investigator Laureen Geniusz, who recommends manufacturer transparency: "If the record is stored in a cave in Pennsylvania, let the investigator know that's why it’s going to take a while to get it."
      PubDate: Tue, 15 Sep 2015 15:00:03 -040
  • FDA's Single-Audit Point Person Sees Device-Maker Benefits In MDSAP
    • Abstract: Kim Trautman, the FDA official working closely with the International Medical Device Regulators Forum on its Medical Device Single Audit Program pilot, envisions many benefits to industry participation, including easier compliance with international quality systems standard ISO 13485 as well as input on the MDSAP program as a whole, she said in an interview.
      PubDate: Mon, 14 Sep 2015 17:45:00 -040
  • Visual Podcast: 12 Steps To Recovery From FDA Form-483 Inspectional
    • Abstract: Manufacturers can find it overwhelming to address problems discovered by agency investigators following a facility inspection. Here to help is former FDA official Cap Uldriks, who unveils a 12-step plan to recovering from Form-483 citations in this "Gray Sheet" educational podcast.
      PubDate: Wed, 09 Sep 2015 11:00:00 -040
  • Be Prepared: FDA Looks Beyond Employee Training Records During Facility
           Inspections, Investigators Say
    • Abstract: Device firms that train employees over and over on the same manufacturing procedures likely have problems that go much deeper. To combat this, two FDA officials urge manufacturers to find root causes for why some employees repeatedly make egregious mistakes.
      PubDate: Tue, 08 Sep 2015 11:00:09 -040
  • Guest Column: Manufacturers, Suppliers Offer Perspectives On Supplier
           Quality Program
    • Abstract: More than 30 companies now participate in the device industry-managed supply chain oversight program MedAccred. “Ultimately, the goal is to achieve a consistently high level of product quality from our special process vendors," Stryker's Bruce Dall explains.
      PubDate: Thu, 03 Sep 2015 14:00:00 -040
  • A Long, Twisted Path To Revision: How The 'Unusual' Makeover Of ISO 13485
           Will Impact Device Manufacturers – And Why There Isn't Much They Can
           Do About It Now
    • Abstract: Staying the course has been an ongoing challenge for the International Organization for Standardization as it works overtime to revise ISO 13485, one of the most widely used quality system standards in medical device manufacturing. There have been obstacles to the latest revision of ISO 13485: some ISO member-countries voted against drafts of the standard for no apparent reason; an inordinate number of industry comments had to be reviewed one-by-one; and the document's redo bumped up against the revision of an even bigger, broader international standard, ISO 9001 – just to name a few headaches...
      PubDate: Thu, 20 Aug 2015 13:20:01 -040
  • New FDA Crackdown On Duodenoscope Makers Includes Warning Letters, 510(k)
           Status Alerts
    • Abstract: FDA takes new enforcement actions against duodenoscope makers in Aug. 12 warning letters to Fujifilm Medical Systems, Hoya and Olympus Medical Systems, charging adulterations to scopes, and noting troubles with CAPAs and reprocessing validation activities. Meanwhile, Fujifilm and Hoya also received so-called "510(k) status" letters.
      PubDate: Mon, 17 Aug 2015 18:35:01 -040
  • Electronic Medical Device Reporting Is Now Mandatory – Is Your Firm
    • Abstract: Although there will be a grace period for eMDR, FDA will return paper-based adverse event reports to manufacturers after Sept. 15. CDRH's Isaac Chang explains.
      PubDate: Fri, 14 Aug 2015 11:00:00 -040
  • Visual Podcast: FDA & Complaints – Your Achilles Heel
    • Abstract: In his third "Gray Sheet" podcast appearance, former FDA official Cap Uldriks offers manufacturers tips and advice to ensure that complaint handling systems are healthy and stay that way.
      PubDate: Mon, 10 Aug 2015 13:15:00 -040
  • From MDR to CAPA: 6 Questions Answered By FDA Investigators
    • Abstract: FDA investigators offer tips and warnings related to Medical Device Reporting, device complaints, the role of 510(k) status in an inspection, IVD considerations, and the path to a warning letter in the latest Compliance Corner column.
      PubDate: Mon, 06 Jul 2015 16:30:00 -040
  • In-Depth With CDRH Compliance Chief: Jan Welch Trumpets 'Case For
           Quality,' Urges Feedback From Manufacturers
    • Abstract: This "Silver Sheet"/"Gray Sheet" Q&A with Jan Welch, interim director of CDRH's Office of Compliance, offers a glimpse into current device center thinking on various activities such as FDA's "Case for Quality." She also warns device manufacturers that if they don't speak up, some issues of importance to them could end up on the back burner. And: Is Welch interested in the job full time?
      PubDate: Mon, 29 Jun 2015 12:30:00 -040
  • Snapshot: Overall Medical Device Recalls Inched Up In 2014; High-Risk
           Class I's Flat
    • Abstract: Medical device recall trends remained relatively unchanged last year despite a slight increase in overall corrections and removals, a "Silver Sheet" analysis finds. Plus: a tally of high-risk class I recalls and a top 5 listing of manufacturers that recalled the most products last year.
      PubDate: Mon, 08 Jun 2015 13:55:01 -040
  • Compilation: 2014 Medical Device Recalls
    • Abstract: A sortable and searchable table of recalls from calendar year 2014. The upshot: there were 62 class I (5%), 1,078 class II (91%) and 46 class III (4%) medical device events last year.
      PubDate: Mon, 08 Jun 2015 13:45:02 -040
  • Warning Letter Roundup & Recap – June 2, 2015
    • Abstract: Employees tasked with reviewing quality audits at Soft Computer Consultants weren't trained on the current version of the firm's audit approval procedure; maker of intra-aortic balloon catheters and inguinal hernia implants cited for QS and MDR reg violations; and more. Four device warning letters were listed by FDA this week.
      PubDate: Wed, 03 Jun 2015 14:00:02 -040
  • Warning Letter Close-Outs – May 2015
    • Abstract: FDA released five close-out letters in May.
      PubDate: Fri, 29 May 2015 12:30:00 -040
  • Warning Letter Roundup & Recap – May 26, 2015
    • Abstract: Six reportable adverse events went uninvestigated at Battle Creek Equipment because the firm only reviewed complaints related to returned product; Signal Medical made changes to its MicroSeal Total Hip Acetabular System that required a new 510(k); and more. Two device warning letters were listed by FDA this week.
      PubDate: Wed, 27 May 2015 14:00:05 -040
  • Warning Letter Roundup & Recap – May 19, 2015
    • Abstract: After evaluating information gathered during an FDA inspection and reviewing ZYTO Technologies' website, the agency discovered that the firm promoted its device for functions outside its cleared intended use; MicroAire had no internal systems for determining whether an event was MDR-reportable; and more. Two warning letters were listed by FDA this week.
      PubDate: Tue, 19 May 2015 14:40:02 -040
  • Warning Letter Roundup & Recap – May 12, 2015
    • Abstract: Anybattery Inc. sold replacement batteries without premarket approval or clearance from FDA; EMcision used electronic signatures to approve numerous procedures despite not having electronic signature systems; and more. Three warning letters were listed by FDA this week.
      PubDate: Tue, 12 May 2015 16:00:00 -040
  • UDI Goes Public: Beta Device Identifier Database Now Online
    • Abstract: FDA has launched the beta version of AccessGUDID as the publicly available face of the Global Unique Device Identification Database. As of May 4, there are 48,093 device records in the searchable system.
      PubDate: Tue, 05 May 2015 17:30:01 -040
  • Warning Letter Roundup & Recap – May 5, 2015
    • Abstract: Smith & Nephew places hold on shipments of Truclear Ultra Reciprocating Morcellators while the firm further investigates problems with the device; maker of medical support stockings didn't evaluate suppliers of fabric, yarn and thread; and more. Three device warning letters were listed by FDA this week.
      PubDate: Tue, 05 May 2015 15:05:00 -040
  • Boston Scientific Uses Risk-Based Process To Swiftly Identify, Correct
           Problem Devices
    • Abstract: The manufacturer's path to a company-wide risk management program was a tough row to hoe after it was issued an FDA corporate warning letter in 2006. But now its quality system is back on track and the firm is finding it easier than ever to deal with nonconforming product by using a risk-based process that involves layers of professional review, the firm's VP of global quality systems says.
      PubDate: Mon, 04 May 2015 14:00:00 -040
  • ‘Cures’ Plan To Rely On 3rd-Party Audits For Some Device
           Changes Needs Tweaks, Shuren Says
    • Abstract: Reliance upon a third-party assessment of quality systems for certain device modifications might eventually help industry, but it would “probably not” be efficient for FDA’s device center, as proposed in the House 21st Century Cures effort.
      PubDate: Thu, 30 Apr 2015 18:00:06 -040
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