Real-Time PMA Supplement Review
Expedited PMA supplement review pathway where FDA and the manufacturer meet to review minor device or labeling changes in real time.
Definition
Real-Time Review is an FDA option for minor PMA supplements where the agency and the manufacturer schedule a face-to-face or virtual meeting to review the proposed change together, with the goal of issuing a decision at or shortly after the meeting. It is appropriate for minor changes to design, software, manufacturing, sterilization, or labeling that do not affect safety or effectiveness. Sponsors must submit eligible-determination requests in advance, and FDA must agree that the change qualifies before scheduling.What this means in practice
Real-Time Review can dramatically shorten the supplement timeline (often weeks instead of months) when used for genuinely minor changes. It is widely used for low-risk software changes, minor label updates, and incremental manufacturing process changes. For software-containing devices, RTR is a common path for changes that fall outside a Predetermined Change Control Plan but are still narrow in scope.- •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.
- •Conflating Real-Time Review with the Special PMA Supplement (manufacturing-change-in-effect) pathway, they apply to different change types.
Related terms
Grouped by themeEditor's picks
· Hand-selected related conceptsPMA submission strategy where a manufacturer submits portions of the PMA (modules) sequentially as they become ready, rather than as a single complete application.
FDA's five-way taxonomy for post-approval PMA changes, Panel-Track, 180-Day, Real-Time, Special, and 30-Day Notice, each with distinct content and timing.
FDA's most stringent device marketing application, required for high-risk Class III devices.
Yearly report required for Class III PMA devices summarizing changes, complaints, and post-approval study status.
More in Regulatory
· Same categoryFDA submission demonstrating a device is substantially equivalent to a legally marketed predicate.
Two alternative disclosure mechanisms in a 510(k) submission, a Summary is public on FDA's website; a Statement promises to share Safety & Effectiveness info on request.
Formal mechanism to ask FDA whether a product is a device and, if so, its likely classification.
510(k) variant that relies on FDA guidance, special controls, or recognized consensus standards.
Where this term appears across MedTech Terms.
Primary references
3 sources- 1
Real-Time PMA Supplements GuidanceVerifiedFDAfda.gov
- 2
IMDRF DocumentsVerifiedIMDRFimdrf.org
- 3
RAPS Regulatory FocusVerifiedRAPSraps.org
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