Regulatory
Real-Time PMA Supplement Review
In one line
Expedited PMA supplement review pathway where FDA and the manufacturer meet to review minor device or labeling changes in real time.
Definition
Real-time PMA supplements are for eligible minor changes affecting safety or effectiveness, such as certain design, software, or labeling changes, for which limited review is appropriate and new clinical data are not needed. FDA determines suitability and uses interactive review. Approval is required before implementation unless another authorized provision applies. Manufacturing-method or process changes should be assessed for the 30-day notice route rather than presumed eligible for real-time review.
Why it matters
Real-time PMA supplements are for eligible minor changes affecting safety or effectiveness, such as certain design, software, or labeling changes, for which limited review is appropriate and new clinical data are not needed. FDA determines suitability and uses interactive review. Approval is required before implementation unless another authorized provision applies. Manufacturing-method or process changes should be assessed for the 30-day notice route rather than presumed eligible for real-time review.
Common pitfalls
- •Requesting Real-Time Review for changes that aren't truly minor, FDA will reject the request and the sponsor loses time.
- •Failing to prepare materials at PMA-supplement quality for the meeting, Real-Time Review compresses calendar time, not depth of evidence.
- •Do not confuse real-time review with a Special PMA Supplement, Changes Being Effected, or with a 30-day manufacturing notice.
Sources
- Real-Time PMA Supplements Guidance · FDA
- IMDRF Documents · IMDRF
- RAPS Regulatory Focus · RAPS
- FDA supplement decision guidance · FDA