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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]
  • 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
  • The Road To Restoring Credibility: How Maintaining A Good Reputation With
           FDA Can Be An Uphill Battle For Manufacturers – But It's Possible
    • Abstract: From our digital archives: Manufacturers can develop a bad reputation with FDA for a variety of reasons, including failing to systemically fix problems or follow through on commitments. “It’s tiresome, frankly, as a regulator, to have firms come in and pay lip service to the steps that they’re going to take, and then not follow up to demonstrate that they’ve taken those steps,” former CDRH Office of Compliance Director Steven Silverman said in December 2011. Two former agency officials also pointed out why FDA doesn’t trust some companies.
      PubDate: Tue, 15 Mar 2016 10:00:00 -040
  • Industry, FDA Outline Costs Of New MDUFA Proposals; Quality Management A
           Strong Focus
    • Abstract: After months of negotiations, the agency has proposed hiring new staff and making significant changes to their device review process that would cost $500 million – on top of current user fee revenues – and does not account for inflation.
      PubDate: Thu, 03 Mar 2016 17:20:02 -050
  • Warning Letter: Exoskeleton Firm Dodged Communication With FDA Over
           Postmarket Study, Failed To Assemble Surveillance Plan
    • Abstract: An FDA warning letter sent to Argo Medical Technologies, now named ReWalk Robotics, outlines the company's failure to conduct mandatory postmarket surveillance activities on its ReWalk bionic walking assistance system. The missive to Argo also lays out a timeline of events that describes how the agency chased after the company.
      PubDate: Wed, 02 Mar 2016 15:15:02 -050
  • It's A Green Light For ISO 13485: Revised Global Quality Systems Standard
           Finally Published
    • Abstract: After five years of high-stakes development, ISO 13485:2016 was published on Feb. 24. The 36-page worldwide quality systems standard carries an official publishing date of March 1, which means firms have until March 1, 2019, to comply.
      PubDate: Fri, 26 Feb 2016 10:00:24 -050
  • FDA Taps Siemens Quality VP To Finally Fill CDRH Compliance Director Job
    • Abstract: Former Siemens exec Robin Newman stepped into the role of director of CDRH's Office of Compliance on Feb. 22. Her appointment means the end of a revolving door of acting compliance heads over the past year.
      PubDate: Thu, 25 Feb 2016 14:30:01 -050
  • Expert: Prepping Suppliers For Surprise Audits Imperative For Device Firms
           Under EU Unannounced Inspection Scheme
    • Abstract: Manufacturers selling product in the European Union must work with critical suppliers to ensure they're audit-ready now that unannounced inspections by notified bodies are standard practice in the EU, an industry expert says. Specifically, it's important for vendors to have procedures in place that address surprise inspections, and device firms should warn suppliers to not turn away third-party auditors when they knock on their door.
      PubDate: Thu, 25 Feb 2016 10:15:02 -050
  • FDA: Out-Of-Spec Components May Be Used In Finished Devices – But
    • Abstract: In our first "Quality Replay" feature, we look back at an educational article from August 2010: Device firms frequently adjust manufacturing processes to accommodate components that are out of specification, but that isn’t necessarily a problem as long as the product meets “finished device specifications and all of its labeling requirements,” FDA's Jan Welch says. During an agency inspection, FDA will check to see whether a firm’s manufacturing change is a one-time exception or if the company makes changes on a regular basis. “The occasional one-off situation for a component or material may be...
      PubDate: Tue, 23 Feb 2016 11:35:02 -050
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