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  Regulatory Science Tools Reduce Risk in New Medical Devices

  How the FDA Catalog of Regulatory Science Tools can reduce risk in medical devices and explores several tools and categories.

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  US Reimbursement Codes for Medical Devices

  The main success criteria for medical device companies after earning FDA regulatory clearance is securing positive coverage decisions from payers. While regulatory approval is sufficient to get a product to market, it has no bearing on product adoption. The availability of reimbursement has a direct impact on therapy adoption – it can “make or break” a product1. This primer provides an overview of US reimbursement codes and when they are used to help determine coverage and payment for medical devices.

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  Pathways to a FDA Approved or Cleared Medical Device

  FDA Approved or Cleared Medical Device – the pathway you choose depends on the level of risk it represents and its intended use.

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  Medical Device Coverage & Reimbursement Tips and Trends

  Summary of expert advice from the Medical Device Coverage & Reimbursement Conference to help guide medical device reimbursement journey.

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  How Regulators are addressing COVID-19 related Medical Device approvals

  Round-up of how Regulators in the US, Europe, and Canada are addressing COVID-19 related Medical Device approvals by QA/RA specialist.

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  FDA Guidance on Non-Clinical Bench Performance Testing Information

  FDA provides a roadmap to follow for premarket submission in their guidance on Content and Format of Non-Clinical Bench Performance Testing.

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  Bringing Consistency to the FDA Inspection Process

  Overview of Device Establishment Inspection Processes and Standards Update that establishes uniform processes and standards for FDA Inspection Process.

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  Double your biotech R&D budget

  How to maximize your biotech R&D budget? Form an academic-industrial partnership. 5 tips for a successful academic-industrial partnership.

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