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FDA Seeks Help on Medical Device Development Tools


Posted in Regulatory and Compliance by Jamie Hartford on September 2, 2014

The agency will work with developers to determine whether certain tools may be developed and qualified to facilitate more predictable, efficient, and transparent regulatory evaluation.


By Jim Dickinson

FDA is soliciting proposals for participation in a medical device development tools (MDDT) qualification pilot program under which the agency will work with developers to determine whether certain tools may be developed and qualified to facilitate more predictable, efficient, and transparent regulatory evaluation when used to generate valid scientific evidence.

Stay on top of all the goings-on at FDA by attending the MD&M Minneapolis conference October 29 & 30, 2014.

A Federal Register notice says the expected benefits of the proposed MDDT qualification process include facilitating timely development of tools that manufacturers and FDA use to assess and measure medical device performance, safety, and effectiveness.

Information gained from the voluntary MDDT pilot program will help “inform” the final guidance document and process, the notice says, adding that the agency plans to prioritize proposals based on public health need or potential to impact multiple device development programs.

The process for MDDT qualification can be started in one of three ways:

  1. A tool developer chooses to pursue qualification for his or her tool to allow for use across multiple device development programs.
  2. Need and interest in an area is determined by individual or consortia of stakeholders.
  3. FDA identifies an area of need and calls for development of tools in a specific area.
Stay on top of all the goings-on at FDA by attending the MD&M Minneapolis conference October 29 & 30, 2014.

Jim Dickinson is MD+DI's contributing editor.

[image courtesy of MRPUEN/FREEDIGITALPHOTOS.NET]


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