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    Additive/3D Printing Manufacturing: Regulatory Concerns

    • 20 June 2018

    This article discusses “3D printing” or “additive manufacturing” for the manufacturing of medical devices, including replacement body parts. It draws much of its material from a new US FDA Guidance document that discusses the unique issues posed by this technology, key concerns due to radically different features of such manufacturing and various ways to address the resulting FDA quality and regulatory concerns relative to ultimate patient safety.

  • Regulatory NewsRegulatory News

    FDA to Begin Updating Generic Cancer Drug Labels With New Congressional Funding

    • 18 June 2018
    The US Food and Drug Administration (FDA) on Monday announced it would use new budget funding to update generic drug labels and will begin with cancer drugs, among other initiatives.
  • Regulatory NewsRegulatory News

    6-Month Delay of Common Rule Changes Explained

    • 18 June 2018
    The Department of Health and Human Services (HHS) and other federal departments and agencies on Monday announced a six-month delay to the federal policy on the protection of human subjects, which is better known as the “Common Rule.”
  • Regulatory NewsRegulatory News

    Combination Products: FDA Updates Inter-Center Consult Request Manual

    • 15 June 2018
    A staff manual detailing the US Food and Drug Administration's (FDA) internal policies and processes for handling inter-center consult requests (ICCR) for combination product reviews has been updated for the first time in 14 years to reflect changes to the process and feedback from external and internal surveys.
  • Regulatory NewsRegulatory News

    FDA Answers Questions on Coding of IVDs

    • 15 June 2018
    In an effort to standardize the information gathered via in vitro diagnostic (IVD) tests, the US Food and Drug Administration issued guidance Friday providing clarifications on the distribution of codes used by manufacturers.

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Recon
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Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
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Feature Articles
Additive/3D Printing Manufacturing: Regulatory Concerns
20 June 2018

This article discusses “3D printing” or “additive manufacturing” for the manufacturing of medical devices, including replacement body parts. It draws much of its material from a new US FDA Guidance document that discusses the unique issues posed by this technology, key concerns due to radically different features of such manufacturing and various ways to address the resulting FDA quality and regulatory concerns relative to ultimate patient safety.

FDA Releases Novel Technical Framework for 3D Printed Medical Devices Emerging Technology Integration in FDA’s Drug Approval Process Regulatory Challenges for Artificial Intelligence Applications in Healthcare
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About Regulatory Focus

Regulatory Focus is the flagship online publication of the Regulatory Affairs Professionals Society (RAPS), the largest global organization of and for those involved with the regulation of healthcare and related products, including medical devices, pharmaceuticals, biologics and nutritional products.

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