For many Breakthrough Devices that are subject to a PMA, in determining that statutory standards for approval have been met, including that the device’s probable benefits outweigh its probable risks, FDA may accept greater uncertainty regarding the device’s probable benefits and risks because of the greater probable public health benefits of earlier patient access. Furthermore, it may be appropriate to collect additional data in the postmarket setting rather than premarket to address the greater uncertainty about the device’s probable benefits and risks. Some postmarket controls to consider include:
It is critical that data collected in the postmarket setting is reliable, high quality, and collected in a timely manner. Therefore, when FDA believes postmarket data collection is appropriate, such as part of a premarket-postmarket data shift, they intend to include timely submission of data from postmarket studies as a condition of approval. FDA already requires postmarket studies as a condition of approval to provide information on the continued reasonable assurance of safety and effectiveness of many approved medical devices. FDA has authority to withdraw the approval of a PMA if conditions of approval, including the collection of postmarket data, are notmet.
For Breakthrough Devices, FDA may require the collection of postmarket data within a specific, appropriate timeframe. Timely postmarket data collection and submission to FDA can be critical to provide patients with an assurance that the device remains reasonably safe and effective. FDA intends to work with sponsors to determine a reasonable time frame for the particular device in situations where postmarket data collection is considered to be appropriate and follow the least burdensome approach to allow for marketing authorization.
In addition to including timely completion and submission of postmarket evidence for a device as a condition of approval, FDA can also include the device labeling, as appropriate. Where postmarket data collection is required as a condition of approval to address greater uncertainty in the device’s probable benefits and risks, FDA intends to consider whether it would be appropriate to include as a condition of approval that the device labeling describe the postmarket data collection and its purpose.
Where applicable, FDA also intends to include such information in the Summary of Safety and Effectiveness Data (SSED) and to flag postmarket studies that are a condition of approval for the device. When the additional postmarket data are provided, and FDA determines that the data are sufficient and continue to support the reasonable assurance of safety and effectiveness of the device, FDA intends to make appropriate changes to the SSED and to inform the sponsor that the sponsor may make appropriate changes to the device’s labeling to reflect the new information.
When the sponsor submits postmarket data as a condition of approval and FDA has questions regarding whether the data continues to support a reasonable assurance of the device’s safety and effectiveness, FDA holds an advisory committee meeting.
When FDA holds an advisory committee meeting, they intend to consider the recommendations of the advisory committee in determining whether the data continues to support a reasonable assurance of the device’s safety and effectiveness, and in determining next steps, which could include issuing a withdrawal order or, if warranted by the data and agreed upon by the PMA holder, certain restrictions on the sale and distribution of the device or narrowing the device’s indications for use.
FDA also intends to take appropriate administrative or enforcement action if a sponsor does not generate and submit the requisite postmarket data within the specified time frame.