The FDA is working to make the premarket review process more efficient. This draft guidance explains how the FDA plans to balance premarket and post-market data collection while still maintaining a high standard of safety. Finding the right balance of data collection will provide patients with faster access to new technology without compromising device or patient safety.
In some cases, the FDA may enforce postmarket requirements to a PMA application, such as continuing evaluation and reporting on the safety, effectiveness, and reliability of a device. The postmarket data will allow the FDA to continue assessment of the risks and benefits of a device with more certainty and to address concerns regarding the safety or effectiveness of a device. “The FDA recognizes that medical device approvals are not made with absolute certainty due to significant obstacles, such as the time and cost involved to address possible rare adverse events or long-term safety and because clinical studies do not fully represent how a device will be used in clinical practice.”
The FDA may approve a device with more uncertain risks if the device has probable benefits and more postmarket controls are in place. Post-approval studies may collect data on adverse events for which there was limited knowledge during premarket review, and review of this postmarket data may result in changes to the labeling or device approval. The FDA may withdraw PMA approval of a device if there is doubt that the device is safe or effective, or they may take action if the required conditions of approval have not been met.
Read the full draft guidance.