FDA Clocks Patent Time for LIMFLOW Medical Gadget
Published Date: 2/26/2026
Notice
Summary
The FDA has officially set the review period for the LIMFLOW SYSTEM, a medical device, so its patent can be extended. This affects the company behind LIMFLOW and anyone interested in patent timing or challenges. If you think the dates are wrong or the company wasn’t careful during review, you can speak up by April 27 or August 25, 2026.
Analyzed Economic Effects
2 provisions identified: 1 benefits, 0 costs, 1 mixed.
FDA Sets LIMFLOW Review Period
The FDA determined the regulatory review period for the LIMFLOW SYSTEM is 2,337 days in total: 2,022 days in the testing phase and 315 days in the approval phase. Key dates used were April 20, 2017 (investigational device exemption effective), November 1, 2022 (PMA submission), and September 11, 2023 (PMA approval); the applicant seeks either 1,033 or 1,327 days of patent term extension and the USPTO will apply statutory limits when calculating the actual extension.
Deadlines To Challenge Dates
People who think the dates are wrong may ask FDA for a redetermination by April 27, 2026, and anyone who believes the applicant did not act with due diligence may petition FDA by August 25, 2026. Petitions must follow the rules in 21 CFR 60.24 and 60.30 and be filed and served in the required manner (see Docket Nos. FDA-2024-E-3555; FDA-2024-E-3564; FDA-2024-E-3565).
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Key Dates
Department and Agencies
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