Devices

Ways to Improve ‘Least Burdensome’ Guidance Suggested

David McFarland

— 1 min read
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Hyman, Phelps & McNamara says an FDA draft guidance on the concept and principles behind the “least burdensome” provisions is extremely important because the concept is a fundamental principle implicated by many FDA decisions that the agency still has not adequately implemented. “Repeated experience has shown that FDA has not consistently applied the least burdensome approach when reviewing marketing applications, including 510(k) premarket notifications, de novo authorizations, premarket approval applications, or investigational device exemptions,” the firm’s comment letter says. “Rather, it has been clear that the data requests did not meaningfully take the least burdensome directive into consideration. While FDA’s letters formulaically stated that the data requests were ‘least burdensome,’ this assertion was not accompanied by any explanation or rationale for why the data that had been submitted was inadequate nor any reasoning why additional information was needed.”

The firm says the draft guidance has some improvements over current practice, but expresses a concern that it still will not affect the way decisions are made or described. The letter makes these recommendations: 

  •         FDA provide a clearly articulated rationale as to why proposed data (for a pre-submission) or the referenced data (for a premarket submission) are not sufficient whenever FDA deems the type or quantity of data to be inadequate;
  •          FDA provide a mechanism for a rapid, meaningful discussion about any requests that an applicant provide data that are substantially different in scope than was submitted;
  •          FDA quickly develop procedures allowing for meaningful assessment of how well the least burdensome program is being implemented; and
  •          FDA adopt a different cultural perspective toward data requests that are quantitatively or categorically different than what was submitted or proposed.

In its letter, AdvaMed recommends that FDA:                              

  •          apply and publish metrics that assess application of least burdensome principles;
  •          explain what it means by least burdensome submissions from industry; and
  •          add to the guidance examples of application of least burdensome principles that draw from agency practice.

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