• Regulatory NewsRegulatory News

    Qualifying Medical Device Development Tools: FDA Finalizes 2013 Guidance

    The US Food and Drug Administration (FDA) on Wednesday finalized guidance first drafted in 2013 to formalize a program that qualifies medical device development tools (MDDT) for use in device development and evaluation programs. Background The MDDT program, which FDA’s Center for Devices and Radiological Health launched as a pilot in 2014 , is a voluntary process intended to reduce regulatory burden for developers and FDA reviewers through the qualification of too...
  • Regulatory NewsRegulatory News

    FDA Unveils Pilot Program Aimed at Accelerating Approvals of New Medical Devices

    The US Food and Drug Administration (FDA) is looking for some help from the medical device industry in the hopes of eventually creating a process of faster, more efficient and more predictable approvals. Background Regulators have long been interested in making sure that tools and measures used during the medical device development process are validated -- that is, proper for use and fit for purpose within a specific context. Many clinical trials are ultimately scrapped...
  • Eyeing Quicker Regulatory Approvals, Regulators Finalize Guidance on Drug Development Tools

    Mere months after releasing a development tools guidance intended for medical device manufacturers, the US Food and Drug Administration (FDA) is following its own lead by releasing an extensive final guidance for the pharmaceutical industry outlining the qualification process for developing and validating drug development tools. Background FDA has placed a strong focus on drug development tools (DDTs) in recent years. At its most basic, a DDT is intended to help guide...
  • Looking to Accelerate Medical Device Development, FDA Unveils New Qualification Process

    A new draft guidance document published by the US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) illustrates a voluntary process by which companies can qualify medical device development tools (MDDT) for use during the development and evaluation of their products. Background Regulators have long been interested in making sure that tools and measures used during the development process are validated-that is, proper for use and fit ...