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A Look at CDRH's Priorities for 2014


Posted in Regulatory and Compliance by Jamie Hartford on December 3, 2013

A new Web site mandated by the Medical Device User Fee Amendments of 2012 reveals some of the guidances and draft guidances on CDRH's to-do list for 2014.  


By Jim Dickinson

        

CDRH has placed developing a draft guidance on benefit-risk determinations in premarket notifications (510(k)s) among its top guidance priorities in 2014. Other top draft guidances to be developed include the following:

  • Appropriate use of voluntary consensus standards in premarket submissions.
  • Custom devices.
  • Hearing aids and personal sound amplification products.
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.

The guidances under development are included in a new CDRH Web site mandated under the Medical Device User Fee Amendments of 2012. The Web site also lists priority draft guidances that will be finalized next year. These include the following:

  • CDRH appeals processes: questions and answers about 517A.
  • Content of premarket submissions for management of cybersecurity in medical devices.
  • Providing information about pediatric uses of medical devices under section 515A of the FDCA.
  • De novo classification process (evaluation of automatic Class III designation).
  • The presubmission program and meetings with FDA staff.
  • The 510(k) program: evaluating substantial equivalence in premarket notifications.
  • Types of communication during the review of medical device submissions.
  • Premarket notification [510(k)] submissions for medical devices that include antimicrobial agents.
  • Applying human factors and usability engineering to optimize medical device design.
  • In vitro companion diagnostic devices.
  • Global unique device identification database.
  • Design considerations for pivotal clinical investigations for medical devices.
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 a contributing editor to MD+DI.

[image courtesy of STUART MILES/FREEDIGITALPHOTOS.NET]


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Priorities

If only one of their priorities was to finish previous priorities.