(AssurX: Morgan Hill, CA) -- 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 functionality of the device, while more detailed safety data are collected in a postmarket study.

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