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  The Silver Sheet
  [5 followers]  Follow
   Full-text available via subscription Subscription journal
   ISSN (Print) 1068-5324
   Published by Informa plc Homepage  [13 journals]
  • Supply Chain Security Targeted By Draft Legislation – But How
           Burdensome Might It Be' Experts Weigh In
    • Abstract: Online-Only Content >>> In an effort to boost the safety and security of supply chains for finished prescription devices, the House Energy & Commerce Committee has proposed legislation that calls for the licensing of wholesale distributors and third-party logistics providers. Specifically, the "Device Distribution Licensing Act" – in the fifth and final section of the draft "21st Century Cures Act" – looks to curb the number of stolen and counterfeit products by requiring distributors and TPLs to be accredited by state or federal agencies by January 2016.
      PubDate: Wed, 18 Feb 2015 13:35:02 -050
  • Recent Warning Letter Close-Outs
    • Abstract: Eight quality-related FDA close-out letters were released from Jan. 15 through Feb. 18.
      PubDate: Wed, 18 Feb 2015 13:30:04 -050
  • Warning Letter Roundup & Recap
    • Abstract: FDA directs Verichem Labs to hire a consultant to help fix quality system troubles; ungloved employees were observed assembling sterile and non-sterile convenience kits at Customed; specification developer Praxair didn't ensure that quality data was analyzed; and more. Six quality-related warning letters were listed by FDA from Jan. 15 through Feb. 18.
      PubDate: Wed, 18 Feb 2015 13:30:04 -050
  • CDRH Appoints Public Health Expert To Lead Post-Market Surveillance Reform
    • Abstract: Gregory Pappas was appointed associate director for National Device Surveillance, a newly established title within CDRH's Office of Surveillance and Biometrics. Papas has been a central figure in public health, including HIV/AIDS policy-setting, for the previous 25 years, but he has not focused specifically on device regulation in the past.
      PubDate: Wed, 18 Feb 2015 13:30:03 -050
  • Companion Guidance For Combo Products Rule Clears Up Some Gray Areas
    • Abstract: The draft guidance provides real-world application, examples and detailed instructions for compliance with agency good manufacturing practice rules for drug delivery devices and other drug/device, drug/biological and drug/device/biological products.
      PubDate: Wed, 18 Feb 2015 13:30:02 -050
  • FDA Chief Heads For Door; Agency's Chief Scientist Will Fill Role –
           For Now
    • Abstract: FDA Commissioner Margaret Hamburg will step down at the end of March.
      PubDate: Wed, 18 Feb 2015 13:30:01 -050
  • Maquet Signs Consent Decree With FDA
    • Abstract: Device-maker Maquet enters into consent decree with FDA to stop making and distributing some hernia mesh, vascular graft and vascular patch products.
      PubDate: Wed, 18 Feb 2015 13:30:01 -050
  • Potential Benefits Of MDSAP Pilot Audits, By Jurisdiction
    • Abstract: What will an MDSAP audit get you? Here are the answers at different spots around the world, according to participating regulatory authorities.
      PubDate: Wed, 28 Jan 2015 12:15:13 -050
  • 10 Inspection Questions Answered By 3 FDA Investigators
    • Abstract: Online-Only Content >>> 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, 28 Jan 2015 12:15:01 -050
  • 10 Key Things To Know About The Medical Device Single-Audit Program
    • Abstract: Online-Only Content >>> After a long build up, four international regulatory authorities officially rolled out the Medical Device Single Audit Program pilot this month. Here are 10 things that FDA wants manufacturers to know about the program.
      PubDate: Wed, 28 Jan 2015 12:15:00 -050
  • PODCAST: 5 Things Every QA/RA Professional Should Keep An Eye On In 2015
    • Abstract: Online-Only Content >>> In this "Silver Sheet" podcast, quality/regulatory expert Christine Santagate reads the tea leaves on five hot industry topics that will unfold over the year.
      PubDate: Wed, 21 Jan 2015 16:00:00 -050
  • CDRH Compliance Director Steven Silverman Departing
    • Abstract: Online-Only Content >>> Steven Silverman is leaving FDA to pursue other opportunities outside of government. "I’ve never had a better job than my current one. Even so, I feel that it’s time for me to gain experience in other areas," said Silverman, who has not signaled what his next move will be.
      PubDate: Wed, 14 Jan 2015 17:45:01 -050
  • Performance Standards Aim To Deliver FDA Guidance Docs To Industry Faster
    • Abstract: Time-based performance standards have been established by CDRH to help ensure that draft guidance documents do not remain in an unresolved state for forever and a day.
      PubDate: Wed, 14 Jan 2015 14:10:01 -050
  • Recent Warning Letter Close-Outs
    • Abstract: Three quality-related FDA close-out letters were released from Dec. 18 through Jan. 14.
      PubDate: Wed, 14 Jan 2015 14:00:19 -050
  • Warning Letter Roundup & Recap
    • Abstract: Karl Storz didn't have design validation data to show that a brush specified in the instruction manual for its Flex-X2 ureteroscope was appropriate for cleaning the device; QS and MDR reg violations identified at maker of coronary bypass cannulas. Six quality-related warning letters were listed by FDA from Dec. 18 through Jan. 14.
      PubDate: Wed, 14 Jan 2015 14:00:14 -050
  • 2014 Hot Spots: Top 4 Device Quality & Regulatory Topics
    • Abstract: Big changes are afoot for inspections, and device stakeholders kept a sharp eye on those issues in 2014, according to "Silver Sheet" readership data. From a CDRH/ORA plan to create a specialized unit of device-focused field investigators, to IMDRF's mostly untested internationally harmonized single-audit approach, readers (and podcast listeners) couldn't get enough news and tips about inspection activities.
      PubDate: Wed, 14 Jan 2015 14:00:03 -050
  • Hospira Infusion Pump Ban Lifted By FDA
    • Abstract: FDA lifts two-year import alert that prevented the manufacturer from selling infusion pumps made at its Costa Rica manufacturing facility, including the Plum A+ and LifeCare PCA.
      PubDate: Wed, 14 Jan 2015 14:00:02 -050
  • IMDRF Wants User Feedback For Medical Device Single Audit Program
    • Abstract: Device firms that undergo an MDSAP inspection through May will be invited by IMDRF to help with midcourse adjustments to the single-audit pilot program.
      PubDate: Wed, 14 Jan 2015 14:00:01 -050
  • CDRH Reviewing, Assessing Guidance Documents From 1985, 1995, 2005
    • Abstract: A plan for systematically reassessing whether established guidance documents need to be revised or withdrawn is unveiled by FDA's device center. CDRH also wants input from the public to identify outdated docs.
      PubDate: Wed, 14 Jan 2015 14:00:01 -050
  • Better Standardize Unique Device IDs, Providers Tell Feds
    • Abstract: Panelists at a recent conference argued the three Unique Device Identification issuing agencies and various automated data capture technologies are making adoption of the system by the health care provider community difficult.
      PubDate: Wed, 17 Dec 2014 15:21:00 -050
  • ‘An Invisible Profession’: Scarcity Of Quality/Regulatory
           Experts A Call To Action For Educators
    • Abstract: Online-Only Content >>> As baby boomers retire, device manufacturers are scrambling to fill quality and regulatory positions – particularly those in leadership roles, according to an industry survey. Yet many firms are discovering that a number of younger employees – those who typically fill gaps left by retiring managers – have not cultivated the necessary quality and regulatory skills demanded by today's complex global market. "A person going into QA/RA now is not going to be only an expert on United States requirements.
      PubDate: Wed, 17 Dec 2014 15:10:00 -050
  • National Joint-Replacement Registry Data Findings
    • Abstract: A new report shows the mean age of knee replacement patients is slightly younger than that of hip replacement patients, and that more females than males are likely to receive joint replacements.
      PubDate: Wed, 17 Dec 2014 15:00:27 -050
  • Manufacturers Should Avoid ‘No Latex’ Claim, FDA Says
    • Abstract: Device manufacturers should avoid making claims that products are “latex-free,” “does not contain rubber latex,” or “does not contain latex,” a new FDA guidance says.
      PubDate: Wed, 17 Dec 2014 15:00:23 -050
  • Years Of Infusion Pump Screw-Ups Leads To Final FDA Guidance
    • Abstract: Years in the making, the agency’s new guidance is in response to a growing number of reported adverse events linked to the use of infusion pumps. The pumps were the top recalled category of medical devices in fiscal years 2012 and 2013, FDA told “The Silver Sheet” earlier this year.
      PubDate: Wed, 17 Dec 2014 15:00:16 -050
  • Surgical-Set Ortho Implants Granted UDI Delay
    • Abstract: Makers of implantable orthopedic devices used as part of customized surgical sets will have an extra year to comply with Unique Device Identification labeling requirements.
      PubDate: Wed, 17 Dec 2014 15:00:12 -050
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