Checklist to Qualify for a Real-Time PMA Supplement

What is a Real-Time PMA Supplement?

Section 737(4)(D) of the Federal Food, Drug, and Cosmetic Act defines a Real-Time PMA Supplement as:

“a supplement to an approved premarket application or premarket report under section 515 that requests a minor change to the device, such as a minor change to the design of the device, software, sterilization, or labeling, and for which the applicant [PMA holder] has requested and the agency has granted a meeting or similar forum to jointly review and determine the status of the supplement.”

If the PMA holder and the FDA agree that the review can be achieved real-time, the PMA holder emails a request for real-time review to the appropriate CDRH or CBER division. The FDA will then respond within 14 days of receipt of the request. In the interactive review, if a meeting is appropriate, that would ideally be scheduled within 30 days of the proposed submission date of the supplement. A Real-Time PMA Supplement does require a user fee. Read more about user fees here: Breakdown of FDA’s Medical Device User Fees.

The Real-Time PMA Supplement should “identify all modifications planned for the device and labeling.” This may include testing and results as well as a detailed risk assessment to show the modified device remains safe and effective. Any incremental modification (or cumulative effects of previous modifications) can impact the safety of the device, so the submitter should be ready to demonstrate mitigation of additional risks.

Read the December 2019 guidance document here: Real-Time Premarket Approval Application (PMA) Supplements – Guidance for Industry and Food and Drug Administration Staff.

What kinds of device modifications are appropriate for real-time review?

The short answer is that Real-Time PMA Supplements are appropriate for a minor change to a device. The examples from the guidance document suggest that a minor change may be a change to device design, software, instructions for use or other labeling that does not affect the indications or contraindications, or sterilization and packing methods.

See the attached Job Aid: Real-Time PMA Supplement Checklist, prepared by Amy Sellers with comments from SoftwareCPR partner John Murray, for a checklist to use in determining whether a device modification is a minor change or a major change.