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Compliance In Focus
Posted by Stephani Hulec on Mon, Dec 2, 2013

New FDA Draft Guidance: Validating Device Development Tools

Recently on November 14th, 2013, the FDA released a new draft guidance regarding medical Validating Device Development Toolsdevice development tools.  Per the FDA release statement, the purpose of this new guidance is to “support the development and timely evaluation of innovative medical devices”.

This guidance refers to a new term - medical device development tools (MDDT); an MDDT is defined on page 6 of the guidance as “a scientifically-validated tool- a clinical outcome assessment…a biomarker test…or non-clinical assessment method or model that aids device development and regulatory evaluation”.  These MDDTs will be qualified for use in the Center for Devices and Radiological Health (CDRH) for device development and evaluation.  The MDDT qualification process is voluntary, for companies that choose to qualify MDDT for use during the development and evaluation of their products.

In this federal register article, the intent of the qualification policy is outlined as such:

  1. To enable fast, more efficient development of important life-saving and health-promoting medical devices
  2. To promote the development of tools to facilitate more timely device evaluation
  3. To provide a mechanism to better leverage advances in regulatory science
  4. To more quickly and more clearly communicate with CDRH stakeholders about important advances in regulatory science that may be leveraged to speed device development and regulatory evaluation

Ultimately, the goal of CDRH is to expedite the development of available tools that may be used across a range of device development programs.  This guidance was drafted in coordination between the FDA and the Medical Device Innovation Consortium in order to foster efficiency and collaboration regarding the establishment of more useful regulatory science tools.

Do you think that the new guidance will achieve the goals intended by the agency?

Photo Credit: Catherine Kolodziej (Calyon)

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Topics: New FDA Guidance, Device Development Tools, CDRH


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