FDA Looks to Fine-Tune the Balance Between Premarket Device Data and Postmarket Requirements

Posted 08 August 2016 | By Zachary Brennan 

FDA Looks to Fine-Tune the Balance Between Premarket Device Data and Postmarket Requirements

The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on Monday announced that it has completed its target goal under its 2014-2015 strategic priority on striking the right balance between premarket and postmarket data.

The goal for CDRH was to review 100% of the medical devices subject to a premarket approval applications (PMAs) approved prior to 2010 to determine, for each product code, whether or not to reduce premarket data collection and rely more on postmarket controls (in order to bring life-saving or other medically necessary devices to market faster) and whether to pursue down-classification for other devices.


As FDA makes clear, the more data a device company needs to collect premarket, the longer it may take to acquire the data and make the PMA submission, meaning the longer it may take US patients to gain access to a new device.

On the other hand, FDA notes, a lack of data to demonstrate a reasonable assurance of safety and effectiveness means a lack of ability in the agency’s assuredness to switch a device’s classification.

“If CDRH can shift, when appropriate, some premarket data collection to the postmarket setting, CDRH could improve patient access to high-quality, safe, and effective medical devices of public health importance,” FDA says. “However, patient safety could be undermined if, after determining that certain data could appropriately be shifted from the premarket to the postmarket setting, CDRH shifted that data collection to the postmarket setting without adequate assurances that necessary and timely postmarket data collection will occur.”

On an ad hoc basis, CDRH has periodically shifted devices from different classifications, depending on the agency's current understanding of the device technology, and though usually the shift was for a down classification, FDA notes that it also has up-classified devices, including in January, with surgical mesh intended for use for pelvic organ prolapse, and in 2014, for tanning beds and booths.

Retrospective Review

During its retrospective review on whether or not to change premarket data collection requirements for some devices, FDA said it received 11 sets of comments generally supporting FDA's retrospective review and offering input on specific procodes that were identified as candidates for reclassification or were determined to remain class III with no change in data collection.

The purpose of Monday’s Federal Register notice is to solicit comments on the remaining procodes that have been identified as candidates for reclassification, via a reduction in premarket data collection through reliance on postmarket controls. A list of devices determined to be candidates for reclassification to Class II include:


FDA also determined (by product code) a list of device candidates for reduction of premarket data collection through reliance on postmarket controls or shift of data collection from premarket to postmarket:




“Efforts to reclassify and to communicate changes to data collections with stakeholders will be prioritized based on both the public health impact and Center resources,” FDA adds.

2014 - 2015 Strategic Priorities Strike the Right Balance Between Premarket and Postmarket Data Collection

Retrospective Review of Premarket Approval Application Devices; Striking the Balance Between Premarket and Postmarket Data Collection: Request for Comments

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