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MDMA Submits Comments on Draft Guidance to 510(k) Substantial Equivalence Decisions

Thursday, October 16, 2014  
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MDMA Submits Comments on Draft Guidance to Address Risk Benefit Factors in 510(k) Substantial Equivalence Decisions

MDMA recently submitted comments on FDA’s draft guidance entitled “Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications [510(k)] with Different Technological Characteristics.”

In issuing the draft guidance, FDA noted it is intended to:

  • Assist FDA reviewers in making substantial equivalence determinations and may help accommodate evolving technology during the 510(k) premarket process; and
  • Help submitters of 510(k) premarket notifications demonstrate substantial equivalence in their premarket submissions.

MDMA commended FDA’s effort to provide much-needed clarity regarding the principal benefit-risk factors that the Agency considers during the premarket review process for 510(k) submissions when there are different technological characteristics between the new and predicate devices.

MDMA noted that where a new device has different technological characteristics than its predicate, the sponsor must demonstrate, among other things, that the new device is “as safe and effective” as a legally marketed predicate device. MDMA stated that “it is critically important that FDA continue to implement 510(k) requirements in a manner that is consistent with the ‘as safe as’ standard . . . In particular, FDA should also ensure that the Agency’s implementation of the Draft Guidance does not become a ‘back door’ for the reassessment of the device classifications of prior decisions.”

In addition, MDMA encouraged FDA to ensure that neither the Draft Guidance nor its application requires data beyond that which has traditionally been required for 510(k) submissions.

To read all of MDMA’s comments and suggestions on this draft guidance, please click here.