Search Results for 'guidance'

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• Surgical
  

  FDA Releases Draft Guidance to Enhance Breast Implant Safety Information

  FDA recommends including a boxed warning and other elements in breast implant labeling.

  U.S. Food and Drug Administration 10.28.19
  

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• Software & IT
  

  HSCC Publishes Guidance on Cybersecurity Risk Management

  Provides actionable guidance and practical tools.

  HSCC 10.16.19
  

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• 3D/Additive Manufacturing
  

  FDA Announces 3D Printed Medical Device Guidance

  World’s first agency to provide a comprehensive technical framework for 3D printed medical product manufacturing.

  Scott Gottlieb, M.D., Commissioner, U.S. Food and Drug Administration 12.06.17
  

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• NICE Provides Positive Guidance for Use of the XprESS Multi-Sinus Dilation System

  Studies show treatment with XprESS Multi-Sinus Dilation System leads to a rapid, sustained improvement in chronic symptoms.

  Entellus Medical Inc. 12.15.16
  

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• R&D & Design | Software & IT | Testing
  

  FDA Updating Guidance on 510(k) Submissions for Product Software Changes

  The U.S. Food and Drug Administration (FDA) has issued a draft guidance document, “Deciding When to Submit a 510(k) for a Software Change to an Existing Device.” This new guidance document applies to software changes only, and addresses t…

  James A. Dunning, CEO, QPC Services 10.12.16
  

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• Contract Manufacturing | R&D & Design | Software & IT | Testing
  

  Mike on Medtech: Guidance on Medical Device Changes Submitted to FDA

  In August, the FDA released guidances offering insight on what changes need to be reported to the agency.

  Videos Sean Fenske, Editor

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• Contract Manufacturing
  

  Mike on Medtech: FDA's Additive Manufacturing & 3D Printing Guidance

  On this debut episode, MPO Editor Sean Fenske and regulatory guru Mike Drues examine the recently released guidance.

  Videos Sean Fenske, Editor

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• Cardiovascular | Contract Manufacturing | Materials | Testing
  

  Sterilization Innovations Lead to New Guidance Document

  It took more than seven years, but the U.S. Food and Drug Administration (FDA) has, at long last, released a final version of its 2008 draft guidance on sterility data needed for 510(k) product submissions. Issued Jan. 21, the guidance applies to med…

  James A. Dunning, QPC Services 05.06.16
  

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• Cardiovascular | Electronics | R&D & Design
  

  FDA Releases Draft Guidance on Adaptive Clinical Trial Design

  Device firms should take the time to determine whether an adaptive design is appropriate, consultant suggests.

  Online Exclusives Christopher Delporte, Editorial Director 06.11.15
  

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• R&D & Design | Testing

  FDA Issues Guidance for Wireless Device Makers

  The U.S. Food and Drug Administration (FDA) has issued its most up-to-date guidance on wireless medical devices. Released by the FDA’s Center for Devices and Radiological Health (CDRH), it is titled “Guidance for Industry and Food and Dru…

  11.30.-1
  

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