FDA Sets Review Timeline for MEDIBEACON Patent Extension
Published Date: 1/5/2026
Notice
Summary
The FDA has officially set the review period for MEDIBEACON, a medical device, which helps the company apply for extra patent time. This means the makers can potentially extend their patent protection, giving them more time to benefit financially. Anyone interested has until March 6, 2026, to share their thoughts with the FDA.
Analyzed Economic Effects
3 provisions identified: 1 benefits, 0 costs, 2 mixed.
FDA Sets Patent Review Period
The FDA determined MEDIBEACON's regulatory review period is 4,175 days in total — 3,598 days in the testing phase and 577 days in the approval phase. That determination establishes the maximum potential length of a patent extension; the applicant seeks 5 years of patent term extension (the PMA was approved January 17, 2025).
MEDIBEACON Approval & Use Limits
MEDIBEACON was approved (PMA P230019) on January 17, 2025 to assess glomerular filtration rate (GFR) in adult patients by noninvasively monitoring fluorescent light from an injected tracer. The device is validated in patients with stable renal function but is not approved for use in patients with GFR 120 ml/min/1.73m2, patients on dialysis, or anuric patients, and it is not intended to diagnose acute kidney injury; the TGFR Sensor and Lumitrace injection are single-use and used only with the MediBeacon TGFR system.
Right to Petition or Comment by March 6, 2026
Anyone who believes the dates published are incorrect may submit electronic or written comments and request a redetermination, and any interested person may petition FDA under 21 CFR 60.24 and 60.30 to challenge whether the applicant acted with due diligence; comments and petitions will be accepted through 11:59 p.m. Eastern Time on March 6, 2026. Petitions must be timely, follow specified filing rules, contain sufficient facts, and certify service on the patent applicant.
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