April 20, 2015

A new FDA guidance issued by the Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER) offers some helpful detail for device firms uncertain if post-approval studies can replace premarket studies at the time of approval for premarket approval applications (PMAs).

The agency says there are some instances where it may consider it acceptable to collect certain data in a postmarket setting rather than premarket.

One area is mature technologies. For example, a subcutaneous implantable cardioverter-defibrillator (S-ICD) has the same basic elements of an ICD, which have been used for decades. Clinical and preclinical evaluations in the premarket setting for the subcutaneous ICD were tailored to collect data on the new aspects and to evaluate the functionality of the device, while more detailed safety data is collected in a postmarket study.

Other situations include an urgent public health need, especially in a situation where postmarket testing would do a better job confirming the benefits of a device.

The guidance spells out several other examples where it may be appropriate, including:

  • Migration, an approach used when approval of Class III in vitro diagnostic devices previously approved, licensed, or cleared assay is shifted to another system for which FDA hasn’t evaluated assay performance, is suitable in cases when sufficient knowledge can be gleaned for the documentation of design controls, risk analyses, and prior performance studies on an already marketed system.
  • Confirmation of mitigation effectiveness for a known risk in a post-approval study.
  • Modifying warnings, contraindications, and/or precautions in approved labeling.
  • Approval for an intended population beyond what was fully evaluated in the pivotal trial, with a confirmatory post-approval study.
  • Assessment of long-term performance in a post-approval study.
  • Assessment of rare adverse events in a post-approval study.
  • Confirmation of bench data with clinical data collected in a post-approval study.
  • Where the performance of a particular device type is well-studied, documented, and understood
  • Where long-term outside the U.S. clinical performance data is available but deemed insufficient.