Search Results for 'guidance'

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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 Announces Interventional Procedure Guidance Supporting Hydrogel Spacer Use in Cancer Treatment

  Decision based on data involving use of SpaceOAR hydrogel to protect surrounding tissue during radiotherapy.

  Business Wire 09.11.17
  

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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  The U.S. Food and Drug Administration (FDA) has issued a draft guidance document, “Deciding When to Submit a 510(k) for a Software Change to an Existing Device.”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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  FDA Clears Expanded Indications for Medtronic’s Sinus Dilation System with Image Guidance

  Clinical study conducted on revision subjects support expanded indication for patients with surgically altered tissue.

  Medtronic 07.12.16
  

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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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• 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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