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Journal Cover The Silver Sheet
  [3 followers]  Follow
   Full-text available via subscription Subscription journal
   ISSN (Print) 1068-5324
   Published by Informa plc Homepage  [16 journals]
  • Photos Snapped During FDA Device Inspections: Fair Game Or Agency
    • Abstract: FDA says it has the authority to take photographs during facility inspections, citing decades-old non-medical-device-related legal cases as evidence – including Dow Chemical Co. v. US – but industry lawyer Robert Klepinski says FDA's reliance on the Dow case as a defense for snapping pictures doesn't pass muster. "The agency always cites the Dow Chemical case, wherein the EPA flew over Dow's plant with a helicopter or airplane and took pictures," Klepinski said, noting that "it’s absolutely ludicrous, a stupid case to cite" because FDA investigators don't inspect device firms from the air.
      PubDate: Tue, 09 Feb 2016 11:00:00 -050
  • Europe Readies For Big Changes In Device Postmarket Surveillance
    • Abstract: Europe may be on the cusp of a big drive toward a more clearly organized and more transparent postmarket vigilance system with new funds directed at the issue in the wake of device safety scandals. The European Commission recently launched the second phase of its joint action plan of near-term device and diagnostics reforms, pushing postmarket surveillance to the top of its agenda.
      PubDate: Thu, 28 Jan 2016 18:00:01 -050
  • Longtime CDRH Quality Systems Expert And International Regulatory Guru Kim
           Trautman Departs From FDA
    • Abstract: The author of FDA's Quality System Regulation and its preamble was snatched up by consulting firm NSF International. At NSF, Kim Trautman will lead the development of an independent third-party regulatory certification program, among other tasks.
      PubDate: Mon, 25 Jan 2016 18:30:11 -050
  • Snapshot: 2015 Medical Device Quality-Related Warning Letters
    • Abstract: A "Gray Sheet" analysis has discovered that the industry racked up its fewest number of FDA quality-related warning letters in nearly a decade. The agency issued 74 letters that included at least one quality system violation in calendar year 2015.
      PubDate: Thu, 21 Jan 2016 11:10:01 -050
  • Compilation: 2015 Medical Device Warning Letters
    • Abstract: Complete list of all 91 FDA device-related warning letters released by the agency last year. The upshot: 73 domestic and 18 foreign manufacturers were sent letters.
      PubDate: Thu, 21 Jan 2016 11:00:01 -050
  • Responding To Cybersecurity Threats: FDA Addresses Postmarket Questions In
           Draft Guidance
    • Abstract: FDA issued a draft guidance on how companies should monitor and respond to potential cybersecurity threats in the postmarket setting. Some cybersecurity problems will require a recall action, but in most cases urgent notification to FDA will not be necessary, the document suggests.
      PubDate: Wed, 20 Jan 2016 11:45:02 -050
  • Podcast: What's Coming Down The QA/RA Pike In 2016' 5 Issues Firms
           Should Keep An Eye On
    • Abstract: In this "Gray Sheet" podcast interview, industry insider Steve Niedelman looks into his proverbial crystal ball and tells what quality and regulatory professionals should watch for this year, including FDA's inspectional program alignment, quality metrics, warning letters, third-party supplier programs and risk management.
      PubDate: Wed, 20 Jan 2016 11:00:02 -050
  • CDRH Prioritizes Leveraging Real-World And Patient-Preference Data,
           Enhancing Quality
    • Abstract: In its 2016-2017 strategic priorities, the device center lays out specific goals for putting more emphasis on real-world postmarket data to support regulatory decisions, making better use of patient-preference input, and enhancing quality at CDRH and in industry. Topping FDA's list: gaining access to 25 million electronic patient records with device identification from global registries, insurance claims data and electronic health records, and expanding that number to 100 million by the end of 2017 to support premarket and postmarket decisions.
      PubDate: Fri, 15 Jan 2016 14:15:02 -050
  • FDA To Weigh Proposals For Lightened Hearing-Aid Regs
    • Abstract: Following a White House report arguing that the current regulation of hearing aids is stifling innovation and raising costs, FDA has scheduled a gathering to discuss the future of hearing aid regulations. The agency has also reopened a comment period on a pending draft guidance.
      PubDate: Thu, 07 Jan 2016 15:15:00 -050
  • Snapshot: Medical Device Recalls 2015
    • Abstract: A "Gray Sheet" analysis of 2015 recalls data shows a dramatic plunge in the number of high-risk class I device recalls reported by manufacturers last year. Check out our infographic, which also includes a tally of all corrections and removals, and a Top 5 listing of firms that recalled the most products in 2015.
      PubDate: Tue, 05 Jan 2016 12:15:02 -050
  • Compilation: 2015 Medical Device Recalls
    • Abstract: A sortable and searchable table of recalls from calendar year 2015. The upshot: there were 43 class I (4%), 1,033 class II (92%) and 46 class III (4%) medical device events last year.
      PubDate: Tue, 05 Jan 2016 12:00:01 -050
  • Canada Sets 2019 Target For Mandatory Adoption Of Single-Audit Program
    • Abstract: The global Medical Device Single Audit Program will become the sole mechanism to demonstrate compliance with Canadian quality management system requirements beginning January 2019.
      PubDate: Mon, 04 Jan 2016 18:00:00 -050
  • FDA Proposes More Stringent UDI Requirements For Some Device 'Convenience
    • Abstract: Under a draft guidance, more devices will require individual Unique Device Identification labels rather than being able to rely on a "convenience kit" exception in FDA's UDI regulation. The agency says surgical instruments packaged together for convenience but used and reprocessed for different procedures are too difficult to track without separately affixed or marked UDIs.
      PubDate: Thu, 31 Dec 2015 15:55:00 -050
  • FDA Kills ISO Voluntary Audit Program As MDSAP Efforts Accelerate
    • Abstract: The agency has terminated a 2012-launched ISO 13485 voluntary audit program, which gave companies the chance for a one-year reprieve from an FDA inspection, to put all attention on the global Medical Device Single Audit Program.
      PubDate: Thu, 17 Dec 2015 17:50:02 -050
  • Podcast: Jay Crowley On The State Of UDI
    • Abstract: Listen to Unique Device Identification guru Jay Crowley talk about persistent UDI compliance questions from manufacturers, plans for FDA enforcement, controversies over standards and technology, and the push for UDI adoption in the broader health care system.
      PubDate: Thu, 17 Dec 2015 10:00:08 -050
  • UDI Expands, Questions Roll In, And Debate Over System Adoption Continues
    • Abstract: As 2015 comes to a close, "The Gray Sheet" looks at the current state of the Unique Device Identification program, persistent challenges for companies and what to expect in the year ahead. UDI guru Jay Crowley provides insight.
      PubDate: Thu, 17 Dec 2015 10:00:01 -050
  • Podcast + Q&A: Device-Makers Shouldn't Ignore Pharma Quality
           Metrics Initiative, Attorney Says
    • Abstract: In a Dec. 9 podcast interview at the Food and Drug Law Institute Enforcement, Litigation and Compliance meeting in Washington, D.C., Alston & Bird partner Cathy Burgess discussed how the FDA’s quality metrics initiative for pharmaceutical companies may also impact expectations for device manufacturers down the line.
      PubDate: Mon, 14 Dec 2015 17:00:01 -050
  • CDRH Compliance Office Looks Ahead To 2016
    • Abstract: More emphasis on informal interactions with companies for minor concerns will be one hallmark of the FDA device center's Office of Compliance agenda for the coming year, according to Acting Director Sean Boyd, who provided an overview of the office's 2016 priorities.
      PubDate: Wed, 09 Dec 2015 18:20:00 -050
  • From 'Back' To 'Front': FDA, Industry Experts Advise Device Manufacturers
           On Best Inspection 'War Room' Practices – And Don't Forget The
           Swedish Fish
    • Abstract: Ever since the first FDA inspection took place decades ago, manufacturers have relied on so-called "inspectional war rooms" – spaces where subject matter experts and others work to fulfill investigator needs – but such back rooms can cause headaches for device firms and stretch out inspections if they select unsuitable workers to staff and manage them. Larry Kopyta, a quality/regulatory VP for Omnyx, says it's vital for employees to be adequately trained on FDA inspection activities, but he notes that it's even more important to not clog up a rear room with an excessive number of workers, warn...
      PubDate: Wed, 09 Dec 2015 15:55:05 -050
  • FDA Orders Custom Ultrasonics To Recall All Endoscope Reprocessors
    • Abstract: The rare recall order comes as a result of a consent-decree violation by the company, which supplies endoscope reprocessors to almost 3,000 hospitals nationwide. FDA says Custom Ultrasonics has failed to validate its device designs, among other concerns.
      PubDate: Mon, 16 Nov 2015 16:45:01 -050
  • Voices From mHealth 2015: Qualcomm Exec Urges Device Firms To Focus On
    • Abstract: As Qualcomm Life continues to build partnerships that allow medical devices to connect through their 2net platform and share patient information, James Mault, the company's chief medical officer, emphasizes that companies should redesign products so they are more user-friendly for patients as devices move to the home setting in this "Gray Sheet" podcast.
      PubDate: Wed, 11 Nov 2015 17:30:00 -050
  • Guest Column: Don't Let These 2 Quality Nightmares Keep You Up At Night
    • Abstract: Former CDRH Office of Compliance Director Steve Silverman advises device manufacturers to address two common "quality nightmares": competitors passing them by as they address quality issues and regulatory enforcement actions that can cause them to fall behind other firms. "Good quality doesn't just save device-makers from less-than-baseline compliance; in fact, good quality usually saves money due to fewer compliance deviations," Silverman writes along with his McKinsey & Co. colleagues David Keeling, Enno de Boer and Ted Fuhr in this "Gray Sheet" Medtech Talk column.
      PubDate: Tue, 10 Nov 2015 12:50:00 -050
  • FDA Investigators Now Assessing UDI Compliance When Inspecting Device
    • Abstract: Investigators have begun checking whether manufacturers are complying with the Unique Device Identification regulation during inspections, and they plan to quiz firms about their UDI readiness – even if they're not required yet to abide by the UDI rule.
      PubDate: Fri, 06 Nov 2015 10:30:01 -050
  • Are Your Suppliers Keeping A Sharp Eye On Critical-To-Quality
           Attributes' You Should Know, FDA Investigators Say
    • Abstract: Too many device firms don't make sure that suppliers of critical components are adhering to specified quality requirements, say two FDA investigators. Further, knowing which supplied components are critical to the quality of devices is something that every manufacturer should be aware of and keep tight control over, they advise.
      PubDate: Tue, 27 Oct 2015 15:40:01 -040
  • Guest Column: Device Firms Stryker Instruments, Heartware Invest In
           Employee Soft Skills – And Reap Big Rewards
    • Abstract: Manufacturers would be wise to train employees on how to effectively communicate with colleagues and FDA, guest columnist Mitzi Perdue says, noting that so-called soft skills such as effective and active listening, critical thinking, effective writing, and influential speaking can be extremely effective in solving an array of problems. "To advance in our company and be successful, you must develop soft skills. And this isn't just happening in my company.
      PubDate: Mon, 26 Oct 2015 14:00:01 -040
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