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4 Recommendations for Improving FDA's Medical Device Submission Process


Posted in Regulatory and Compliance by MDDI Staff on January 16, 2014

An independent study called for under MDUFA III laid out four ways FDA could improve the medical device submissions process. 


By Jim Dickinson                         

                    

A Booz Allen Hamilton study called for under the third Medical Device User Fee Ammendments (MDUFA III) to assess FDA’s process for reviewing medical device submissions has identified four actions the agency could take to improve the efficiency and review times of the submission review process.

Stay up to date on the goings-on at FDA by attending the FDA and Global Regulations in Practice conference track at MD&M West in Anaheim, CA, February 10–13, 2014.

Under MDUFA III, FDA agreed to collaborate with industry on a comprehensive independent assessment of the process for reviewing medical device submissions. The following recommendations were made based on the assessment:

  • Develop criteria and establish mechanisms to improve consistency in decision-making throughout the review process.
  • Provide mandatory full-staff training for the three primary IT systems that support MDUFA III reviews.
  • Identify metrics and incorporate methods to better assess review process training satisfaction, learning, and staff behavior changes.
  • Adopt a holistic, multipronged approach to address five quality component areas to standardize process lifecycle management activities and improve the consistency of reviews.

The Booz Allen Hamilton consultants who conducted the assessment say the four priority recommendations address key areas of concern identified by industry and FDA, and are intended to resolve issues that would otherwise impede the success of the MDUFA III review processes going forward.

Stay up to date on the goings-on at FDA by attending the FDA and Global Regulations in Practice conference track at MD&M West in Anaheim, CA, February 10–13, 2014.

—Jim Dickinson is MD+DI's contributing editor.  

[image courstesy of STOCKIMAGES/FREEDIGITALPHOTOS.NET]


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