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  The Silver Sheet
  [2 followers]  Follow
   Full-text available via subscription Subscription journal
   ISSN (Print) 1068-5324
   Published by Informa plc Homepage  [14 journals]
  • 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
  • Warning Letter Close-Outs – April 2015
    • Abstract: Ten FDA close-out letters were released in April.
      PubDate: Thu, 30 Apr 2015 12:00:01 -040
  • Warning Letter Roundup & Recap – April 28, 2015
    • Abstract: Complaints weren't evaluated and investigated at Applied Medical Resources, including two reports of death related to its Kii Shield Bladed System; Natus Medical didn't notify FDA after it sent three technical bulletins to customers to make changes to neoBLUE devices; and more. Two device warning letters were listed by FDA this week.
      PubDate: Tue, 28 Apr 2015 15:55:01 -040
  • Warning Letter Roundup & Recap – April 21, 2015
    • Abstract: FDA wasn't notified after Thermedx made 21 software upgrades to devices in the field; manufacturer of air filters and spirometers failed to analyze quality data; and more. Six device warning letters were listed by FDA this week.
      PubDate: Fri, 24 Apr 2015 11:45:01 -040
  • Visual Podcast: 9 Risk Management Questions Firms Should Ask When Making
           Design Changes
    • Abstract: Changes to international standard ISO 13485 are coming – are you ready? Steris' Bill Brodbeck talks about how the revised standard will require more risk management activities, and he encourages manufacturers to ask themselves nine questions related to risk when making device changes in this "Silver Sheet" visual podcast.
      PubDate: Thu, 23 Apr 2015 11:00:01 -040
  • Visual Podcast: 'System Of Quality' Approach Is Shot In Arm For
           Conventional QMS, Eli Lilly Quality Leader Explains
    • Abstract: Manufacturers that implement a so-called "system of quality model" will be best suited to assess traditional quality management systems in preparation for even more digital devices reaching the market, an Eli Lilly global quality leader says in this "Silver Sheet" visual podcast.
      PubDate: Tue, 21 Apr 2015 11:00:01 -040
  • Warning Letter Roundup & Recap – April 14, 2015
    • Abstract: Employees weren't trained in GMP, quality, CAPA and manufacturing equipment procedures at Visionary Contact Lens; maker of air filters and spirometers cited for quality system reg violations; and more. Three device warning letters were listed by FDA this week.
      PubDate: Thu, 16 Apr 2015 21:50:01 -040
  • First Firm Audited Under MDSAP Urges Companies To Pay Closer Attention To
           International Regs
    • Abstract: Orthopedic device manufacturer Arthrex was the inaugural auditee of IMDRF's Medical Device Single Audit Program. During the inspection it was dinged by auditors when the company wasn't wholly familiar with Australian regulatory requirements.
      PubDate: Fri, 10 Apr 2015 15:20:02 -040
  • European Union Finally Joins MDSAP Work Group – But Only As
    • Abstract: The European Commission sent representatives to a March 23 meeting related to IMDRF's Medical Device Single Audit Program. But for now they'll only be observing, FDA's Kim Trautman says.
      PubDate: Wed, 08 Apr 2015 17:20:00 -040
  • FDA's 'Critical-To-Quality' Inspectional Approach Might Not Extend To
           IMDRF Single-Audit Program
    • Abstract: While FDA is busy pushing its investigators to apply a "critical-to-quality" mindset when auditing device firms, the International Medical Device Regulators Forum's MDSAP program won't necessarily touch on so-called CTQ points.
      PubDate: Wed, 08 Apr 2015 14:15:01 -040
  • Warning Letter Roundup & Recap – April 7, 2015
    • Abstract: No device warning letters were released by FDA this week.
      PubDate: Tue, 07 Apr 2015 09:50:01 -040
  • FDA Investigators Will Remain Well Rounded Despite Commodity-Based Silos,
           CDRH Official Says
    • Abstract: Some stakeholders have expressed concern that FDA's move to more product-specific field forces will hamstring the agency's ability to respond to unexpected public health challenges, but top CDRH official William McFarland says that is not going to happen. Investigators will continue to be well rounded, he said.
      PubDate: Wed, 01 Apr 2015 17:00:01 -040
  • Warning Letter Roundup & Recap – March 1-31, 2015
    • Abstract: Manufacturer of the LIBBE Colon Hydrotherapy Irrigation System cited for QS and PMA reg violations; Inovo didn't determine a root cause after reports of pulse malfunction troubles with certain lines of oxygen conservers; poor CAPA procedures and corrective actions cause problems at XZeal Technologies; and more. Seven device warning letters were listed by FDA in March. (Editor's Note: Beginning April 7, Warning Letter Roundup & Recap will post weekly.)
      PubDate: Wed, 01 Apr 2015 06:15:12 -040
  • Visual Podcast: 10 Tips For Writing Effective IFUs For Medical Devices
           – And More
    • Abstract: In the wake of troubling patient infections and deaths due to improperly sterilized duodenoscopes, human factors experts Michael Wiklund and Jonathan Kendler of UL-Wiklund Research & Design provide tips on writing effective instructions for use in this "Silver Sheet" visual podcast.
      PubDate: Wed, 01 Apr 2015 06:15:08 -040
  • Guest Column: Bulletproofing The CAPA Process
    • Abstract: FDA compliance expert John Avellanet takes a look at some of the reasons why corrective and preventive action – CAPA – continues to be a top observation noted in FDA-483 inspection forms and agency warning letters. “An effective, compliant CAPA process produces clear objective evidence easily reviewed by an FDA investigator, ISO auditor or even a product liability litigator,” Avellanet writes.
      PubDate: Wed, 01 Apr 2015 06:15:05 -040
  • Apply Risk Analysis Concepts To Quality Data Reviews To Pinpoint Severe
           Device Problems Faster
    • Abstract: Device-maker Steris' director of regulatory affairs explains why it's important for device manufacturers to view quality data through the prism of risk management.
      PubDate: Wed, 01 Apr 2015 06:15:02 -040
  • FDA: Don't Wait On 'Case For Quality'; 'Build Bridges' To
           Better-Than-Baseline Practices Now
    • Abstract: FDA device center official William MacFarland is encouraging manufacturers to discover paths to better product quality by going above and beyond baseline GMP requirements. In the meantime, CDRH is making progress in its "Case for Quality" "critical-to-quality" pilot program, including the creation of 13 new CTQ information documents drafted by the agency, the director of the Division of Manufacturing and Quality within CDRH’s compliance office said.
      PubDate: Wed, 01 Apr 2015 06:10:22 -040
  • Visual Podcast: UDI 2.0 – What You Can Learn From Other
           Manufacturers' Unique Device Identification Mistakes
    • Abstract: In his second podcast appearance, Jay Crowley – FDA's former senior advisor for patient safety and the Founding Father of the UDI system – addresses roadblocks companies have faced and how they can learn from others' mistakes. Crowley is currently VP of UDI Services and Solutions with consulting firm USDM Life Services.
      PubDate: Wed, 01 Apr 2015 06:10:15 -040
  • Guest Column: 4 Reasons Why Your Firm Should Use A Single-Audit Program
    • Abstract: Health Canada veteran and International Medical Device Regulators Forum participant Don Boyer urges medical device manufacturers to take IMDRF's Medical Device Single Audit Program seriously.
      PubDate: Wed, 01 Apr 2015 06:10:10 -040
  • 10 Inspection Questions Answered By 3 FDA Investigators
    • Abstract: FDA National Device Expert and investigator Phil Pontikos, along with fellow investigators Marc Neubauer and Lori Lawless from the agency's Baltimore district office, answer ten queries from medical device manufacturers.
      PubDate: Wed, 01 Apr 2015 06:10:00 -040
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