FDA update March 28, 2012

Factors to consider when making Benefit – Risk determinations in Medical Device Premarket Approval and De Novo Decisions.


  • Premarket approval (PMA) is the FDA process of scientific and regulatory review used to evaluate the safety and effectiveness of Class III medical devices.
  • Class III devices are those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential unreasonable risk of illness or injury.
  • The de novo process is available for low- and moderate-risk devices that have been found not substantially equivalent (NSE) to existing devices.
  • When evaluating PMA applications or de novo petitions, the FDA relies upon valid scientific evidence to assess safety and effectiveness. Both clinical and non-clinical data play a role in FDA’s benefit-risk determinations. 

Scope of the Guidance:

  • The guidance document explains the principal factors that FDA considers when making benefit-risk determinations in the premarket review of certain medical devices.
    • The processes discussed in this guidance are applicable to devices subject to premarket approval (PMA) applications or de novo classification petitions.
    • The guidance applies to both diagnostic and therapeutic devices.

    Purpose of the Guidance :

    • To provide knowledge about different factors that FDA considers while making benefit – risk factors determination. For example – assessment of benefits of devices like type of benefits, magnitude of benefits etc., assessments of risks of devices like device related serious adverse events, probability of harmful events, duration of harmful events etc..
    • To provide with certain examples of benefit – risk determinations which would give a broader and a practical idea of the application of the guidance to the premarket approval applications and de novo petitions.
    • To outline the systematic approach FDA device reviewers take when making benefit-risk determinations during the    premarket review process
    • To furnish manufacturers a helpful tool that explains the various principal factors considered by the agency during the review of PMA applications, the regulatory pathway for high-risk medical devices, and de novo petitions, a regulatory pathway available for novel, low- to moderate-risk devices
    • To describe an approach that takes into account patients’ tolerance for risks and perspectives on benefits, as well as the novelty of the device.


    The guidance is a helpful tool for medical device manufacturers and the main goal of this guidance is to describe how the benefits and risks of certain medical devices are considered during pre-market review.

    If you want to discuss the factors considered while making benefits-risk determination for premarket approval applications and de novo petitions please contact mdi at info@mdiconsultants.com, and reference: DeNovo.

    The following is the link for the guidance: