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Journal Cover The Silver Sheet
  [2 followers]  Follow
   Full-text available via subscription Subscription journal
   ISSN (Print) 1068-5324
   Published by Informa plc Homepage  [16 journals]
  • 'Program Alignment' Wants You: Why FDA Is Soliciting Input From Industry
           For New Facility Inspection Initiative
    • Abstract: The agency is reaching out to manufacturers and other stakeholders for input on communication and training issues related to its upcoming "program alignment" facility inspection scheme, which aims to make inspections more predictable and consistent for investigators and device firms.
      PubDate: Wed, 29 Jun 2016 17:00:01 -040
  • Plan To Sue A Slipshod Supplier To Recoup A Civil Litigation Judgment'
           When It Comes To Implantable Device Parts, You May Have To Think Again
    • Abstract: While negligent suppliers of failing components are typically sued by end-product manufacturers to recover their fair share of civil or government money damages, vendors that sell parts for most implantable devices are largely shielded from liability by a not-oft-talked-about federal act. The Biomaterials Assurance Act of 1998 "provides immunity for suppliers of components in medical devices based on the notion that it’s the manufacturer of the actual device that is responsible for ensuring the safety of the products before they’re put onto market," attorney Lauren Colton says. "And under that...
      PubDate: Wed, 22 Jun 2016 11:20:01 -040
  • Ex-CDRH Compliance Leaders And Regulatory Experts Offer Tips For Surviving
           Face-To-Face Meeting With FDA
    • Abstract: From our digital archives: When device manufacturers fail to prepare for FDA meetings, they miss a golden opportunity to exchange ideas, have their viewpoints heard and gain advice from agency staffers, former CDRH compliance officials maintain. If a firm didn’t come to a meeting prepared, “then it felt like we wasted our time because now we had to have another meeting or communication round to try to get to the issues,” says Larry Spears, a one-time deputy director of regulatory affairs in the device center’s compliance office.
      PubDate: Wed, 15 Jun 2016 10:45:02 -040
  • Q1 Snapshot: Device Recalls Fell Over Past Two Quarters; Troubles With
           Quality, Labeling Top List Of Recall Causes
    • Abstract: The number of device recalls dropped over the past six months, but the downward trajectory likely will not hold through the remainder of 2016, an industry expert says. Meanwhile, mislabeling and quality problems caused the most headaches for manufacturers in the first quarter of 2016, registering as the top two causes for a recall.
      PubDate: Thu, 09 Jun 2016 12:05:01 -040
  • Investigator Horror Stories: Industry Insiders Tell Of FDA Inspectional
           Nightmares – And How Device Firms Handled Them
    • Abstract: In this "Compliance Corner" feature, two industry experts give real-world examples of potential FDA inspectional overreaches, including one investigator who followed a device firm's employee into a restroom to stop her from using a cell phone. Yes, that actually happened – and it's just one of many inspectional nightmares that manufacturers have faced when inspected by the agency.
      PubDate: Tue, 07 Jun 2016 12:30:01 -040
  • Guest Column: Device Firm Instructors Must Heartily Engage Trainees To
           Curb Boredom, Top Industry Coaches Recommend
    • Abstract: In this Gray Sheet guest column, writer Mitzi Perdue explains that trainers at medical device firms must work fast and engage company employees if they want to get their message across before the workers' eyes glaze over. Perdue highlights three industry trainers who employ various methods – from avoiding PowerPoint slides to using "sound bites" – to keep trainees' eye on the ball.
      PubDate: Wed, 01 Jun 2016 09:40:02 -040
  • Podcast: From FDA Inspections And Adverse Event Reports, To Medical Device
           Cybersecurity, Here's A 'Spring Cleaning' List
    • Abstract: In this Gray Sheet educational podcast, former longtime FDA official Cap Uldriks urges manufacturers to make certain that facilities are spick-and-span, especially now that it's springtime. But dirt isn't the only thing firms should keep an eye on: Uldriks' "spring cleaning" list also includes valuable information on Medical Device Reporting, adequate wireless technology designing, clean room maintenance activities and cybersecurity measures, among others.
      PubDate: Tue, 31 May 2016 16:55:01 -040
  • Would-Be FDA 'Maturity Model' Pilot Might Reward Firms With Delayed
    • Abstract: "Mature" device manufacturers could put off an FDA inspection for a few years if they independently verify that they have robust quality metrics in place under a potential pilot program, CDRH's new compliance head says. The pilot would be part of FDA's plan under its Case for Quality to use a maturity model to prioritize facility inspections.
      PubDate: Thu, 19 May 2016 12:35:03 -040
  • ORA Device Director: Inspection 'Program Alignment' Scheme Not Ready
           Anytime Soon; Investigator Training, Retention Pose Challenge For FDA
    • Abstract: More details about FDA's new commodity-specific inspectional approach continue to emerge, including news that the Office of Regulatory Affairs is under pressure to train agency investigators while simultaneously dealing with the loss of several highly trained auditors to the agency's device center. All of this comes amid a sign-off process on "program alignment" that will extend all the way to Capitol Hill.
      PubDate: Tue, 17 May 2016 15:50:01 -040
  • Software Poses Unique Challenges For Both Device Firms And FDA; Recurrent
           Troubles With Software Testing, Design Control, Documentation A Concern
    • Abstract: From our digital archives: Problems with device software, such as the use of aging microprocessors and platforms, alarm FDA, said Al Taylor with the agency's Office of Science and Engineering Laboratories, who said the agency has “seen several instances where problems arose because the firm was way, way past the point where a prudent person would have made the choice to move to a more powerful and capable platform." Companies are also falling down on software quality by not following design controls, not conducting testing and failing to create thorough requirements documents. The internationa...
      PubDate: Mon, 16 May 2016 13:20:02 -040
  • FDA Investigators Tell What They Look For When Inspecting Facilities –
           But Device Firms Won't Choke If They Adequately Prepare
    • Abstract: Device manufacturers are being reminded by FDA to make sure that everyone in their organization is familiar with procedures related to agency inspections – but firms will be able to handle that and more if they prepare for audits in advance, industry professional Connie Hoy points out. "At device firm Cynosure, "we prepare the entire organization, from the CEO down, for an inspection and what to expect," she says in this Gray Sheet "Compliance Corner" feature.
      PubDate: Wed, 27 Apr 2016 14:25:00 -040
  • Make Sure SOPs For FDA Inspections Are Robust, Industry Experts Say –
           And Don't Forget To Train The Receptionist
    • Abstract: In this Gray Sheet "Compliance Corner" feature, Cynosure's Connie Hoy explains how standard operating procedures for FDA inspections are structured at her device manufacturing firm – and urges others to ensure they even have such procedures in the first place. "The purpose of that SOP is to direct the organization toward how you as a company – and the executive management of the company – expect to manage an FDA inspection, or any inspection, for that matter," she says.
      PubDate: Thu, 21 Apr 2016 11:55:00 -040
  • Production & Process Control Pops Up In Most 2015 Warning Letters; OUS
           Firms Corner Market On P&PC Problems, FDA Official Says
    • Abstract: FDA's production and process control requirements continue to dog the medical device industry, yet agency official Sean Boyd says an overall uptick in P&PC violations is primarily due to FDA's abbreviated Level 1 inspection technique, which will almost always include P&PC scrutiny by agency investigators. But two industry experts – including a longtime FDA veteran – say problems with production and process controls run much deeper than a simple audit approach.
      PubDate: Tue, 19 Apr 2016 13:20:00 -040
  • The Tricky Business Of Environmental Control
    • Abstract: From our digital archives: Manufacturers must keep a firm grasp on environmental controls to avoid potentially tough regulatory penalties. “Clearly environmental controls are important, and FDA will and can take major regulatory action when environmental controls aren’t being adhered to,” ex-FDA official Kim Trautman said in September 2011. Communication is cited as an important aspect for firms as they attempt to ensure that facilities meet FDA’s environmental control requirements.
      PubDate: Mon, 18 Apr 2016 15:05:01 -040
  • Make Sure Process Validation Is Conducted By 'Qualified' Personnel,
           Experts Say
    • Abstract: From our digital archives: Process validation activities must be conducted by “qualified” employees to ensure product quality, experts said. In general, manufacturers must show that individuals who perform process validation are thoroughly familiar with what they are validating, and that they have appropriate credentials. “There definitely is a technical level of confidence that is extremely important” in conducting process validation, Philips Healthcare's Elisabeth George said in September 2011.
      PubDate: Mon, 18 Apr 2016 15:05:00 -040
  • ISO 13485 Update: Worries About Firms Missing 2019 Deadline; Quality
           Systems Standard Handbook In The Works; Suppliers Now Eligible For Certs
           – And More
    • Abstract: Device manufacturers might be tempted to put off becoming certified to the newly revised ISO 13485 because they've been given three years to conform to the global quality systems standard. But not so fast, says ex-FDA official Kim Trautman, who's worried that ISO's three-year window for companies to comply will "lull people into a false sense of security": "Not every firm has three years, per se, to transition from the 2003 version of ISO 13485 to the 2016 version; some firms might only have one year depending on how their certifications are laid out," she warns.
      PubDate: Mon, 11 Apr 2016 12:40:01 -040
  • Joint FDA/ASQ Case For Quality Library Launched
    • Abstract: FDA and the American Society for Quality has unveiled a Case for Quality Library that showcases best-in-industry quality practices.
      PubDate: Mon, 11 Apr 2016 11:15:02 -040
  • Visual Podcast: FDA/Xavier Joint Initiative Aims To Help Device Firms
           Predict Quality Metrics
    • Abstract: In a second Gray Sheet educational podcast, Xavier University's Marla Phillips explains a partnership between FDA and the school on a metrics initiative to identify, pilot, plan and publicize predictive quality system metrics. "We're looking at … developing a system of metrics across the total product lifecycle. In doing that, it enables companies to assess and improve the robustness of their critical-to-quality practices and, therefore, risk to product quality," she says.
      PubDate: Tue, 05 Apr 2016 14:00:01 -040
  • Visual Podcast: Applying Risk Concepts To Supply Chains And Product Lines
           Can Be A Snap, Expert Says
    • Abstract: In this Gray Sheet educational podcast, Xavier Health's Marla Phillips explains how a Xavier University initiative uncovered major paradigm shifts that enable industry to apply risk concepts to supply chains and product lines via an approach that promises immediate impact. "We need greater assurance that suppliers can reliably and consistency supply reliable, safe, quality materials and products to limit adverse impact on end-user safety and brand equity," she says.
      PubDate: Tue, 05 Apr 2016 11:40:01 -040
  • Podcast: ISO 13485 Redo Takes Front Seat In Exclusive Interview With
           Ex-FDA International Quality Systems Expert Kim Trautman
    • Abstract: In her first interview since leaving the agency in January, FDA’s former international quality systems expert Kim Trautman – author of FDA’s Quality System Regulation and one of the chief architects of the global Medical Device Single Audit Program – talks to The Gray Sheet about what manufacturers should keep an eye on when it comes to quality systems standard ISO 13485, and also discusses her new role in the public sector.
      PubDate: Thu, 31 Mar 2016 12:20:00 -040
  • Guest Column: Labeling, Packaging Front-And-Center As Unique Device
           Identifiers Move Forward, Survey Shows
    • Abstract: In this Gray Sheet guest column, Prism ID’s Kevin Grygiel ticks off survey responses from the device industry that shows that manufacturers are generally OK with UDI implementation, but still have trouble with some of the details. Further, the firm’s survey shows that one-third of respondents don’t believe they are ready for FDA inspections involving review of UDI activities and materials.
      PubDate: Tue, 29 Mar 2016 13:45:05 -040
  • Domestic, Foreign Manufacturers Achieve Virtual Quality-Related FDA
           Warning Letter Parity; Missive-Counting Methodologies Explained
    • Abstract: Quality-related warning letters sent to foreign device manufacturers are on the rise, FDA data shows: 62 domestic and 59 non-US firms received letters that included at least one violation of the Quality System Regulation. Also: FDA's yearly warning letter count has closely mirrored separate analyses by The Gray Sheet for more than a decade, yet over the past two years those counts have wildly diverged; we explain why.
      PubDate: Mon, 28 Mar 2016 10:55:01 -040
  • Design Control Snapshot: Advice About Design Change, Files, Inputs And
    • Abstract: From our digital archives: Device changes and design history files are integral aspects of design control that work hand-in-hand and should not be overlooked by manufacturers, industry experts said. Firms should keep copious records of design changes that can later be reviewed in a design history file (DHF); otherwise they could encounter what one expert dubbed “change creep.” This happens when a manufacturer makes numerous changes to a product, “and then all of a sudden we have a design that doesn’t even look like the original device,” John Gagliardi of MidWest Process Innovation said in Dece...
      PubDate: Mon, 28 Mar 2016 08:00:01 -040
  • Senate Bill Would Encourage Adverse-Event Reporting Experimentation
    • Abstract: The new Improving Medical Device Innovation Act contains device provisions paralleling the House 21st Century Cures Act to make it easier for FDA to recognize consensus device standards, reform the advisory panel process and encourage more 510(k) exemptions. It also includes a new proposal that would trigger pilot projects for alternative approaches to adverse-event reporting.
      PubDate: Tue, 22 Mar 2016 17:50:00 -040
  • Kiss Your FDA Regional Office Goodbye: Big Changes Afoot Thanks To ORA’s
           Inspectional Program Alignment
    • Abstract: FDA’s five regional offices will be made whole and its 20 district offices scrambled under the Office of Regulatory Affairs' plan to align facility inspections along commodity-specific product lines, an agency official says – one of several bits and pieces of information trickling out about the coming scheme. “This is the most dramatic change that ORA has experienced, maybe in its history,” says Sean Boyd, acting deputy director in CDRH’s Office of Compliance.
      PubDate: Mon, 21 Mar 2016 09:30:01 -040
School of Mathematical and Computer Sciences
Heriot-Watt University
Edinburgh, EH14 4AS, UK
Tel: +00 44 (0)131 4513762
Fax: +00 44 (0)131 4513327
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