WRAPSODY Device Patent Review Locked in by FDA
Published Date: 2/26/2026
Notice
Summary
The FDA has officially set the review period for the MERIT MEDICAL WRAPSODY device, which helps extend its patent protection. This means the company can apply for extra patent time, giving them more control over their invention. If anyone thinks the dates are wrong or the company wasn’t careful during the review, they can speak up by April or August 2026.
Analyzed Economic Effects
3 provisions identified: 3 benefits, 0 costs, 0 mixed.
Applicant requests 908‑day patent extension
Merit Medical Systems filed patent-term restoration applications for U.S. Patent Nos. 10,005,269 and 10,028,852 and, in its USPTO application, seeks 908 days of patent term extension. The FDA notes its determination establishes the maximum potential length, and the USPTO will apply statutory limitations when calculating the actual extension.
FDA sets WRAPSODY review period
The FDA determined the regulatory review period for MERIT MEDICAL WRAPSODY is 1,639 days total, including 1,462 days of testing and 177 days of approval. Key dates the FDA verified are: investigational device exemption effective June 26, 2020; premarket approval (PMA P240023) submitted June 26, 2024; and PMA approval on December 19, 2024.
Public comment and petition deadlines
Anyone who believes the published dates are incorrect may ask FDA for a redetermination by April 27, 2026. Any interested person who believes the applicant did not act with due diligence during the regulatory review period may petition FDA by August 25, 2026.
Personalized for You
How does this regulation affect your finances?
Personalize government policy and PRIA will tell you what this federal register document means for your household, plus every other regulation we track. PRIA reads each provision against your financial profile to show you exactly what matters to your wallet.
Key Dates
Department and Agencies
Related Federal Register Documents
2026-16296, Substances Generally Recognized as Safe
The Food and Drug Administration (FDA or we) is proposing to require the submission of generally recognized as safe (GRAS) notices for the use of a human or animal food substance purported to be GRAS under the conditions of its intended use under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
2026-14073, Drug Establishment Registration and Drug Listing Requirements for Establishments Engaged in Distributed Manufacturing and Certain Foreign Establishments
The FDA wants to make it easier for drug makers who work in several locations to register as one company instead of many. They’re also updating rules for foreign drug companies to match new laws about handling health threats. If you’re in drug manufacturing, get ready to comment by September 11, 2026, and keep an eye on possible paperwork changes that could affect your business.
2026-13047, Establishment Registration and Product Listing for Tobacco Products
The FDA wants to make sure all tobacco product makers, both in the U.S. and abroad, register their businesses and list their products. This new rule closes a big gap by including foreign companies, helping the FDA keep better track of tobacco products for public health. Comments on this proposal are open until September 14, 2026, so affected businesses should get ready to update their info and possibly face new costs.
2025-04978, Nonprescription Drug Product With an Additional Condition for Nonprescription Use
The FDA is delaying a new rule about nonprescription drugs that have extra conditions for use. Originally set to start on March 21, 2025, the rule’s start date is now pushed back to May 27, 2025, to allow more time for review. This affects drug makers and consumers by giving everyone extra time to prepare for the new requirements without any immediate cost changes.
2025-01840, Nonprescription Drug Product With an Additional Condition for Nonprescription Use
The FDA’s new rule about nonprescription drugs needing extra conditions before use was set to start on January 27, 2025, but it’s now delayed until March 21, 2025. This delay follows a presidential order to pause and review new rules before they take effect. Drug makers, sellers, and consumers should note the new start date and get ready for the updated rules soon.
2026-20085, Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Voluntary Improvement Program
The FDA is asking for public feedback by November 2, 2026, on its Voluntary Improvement Program (VIP), which helps medical device makers improve quality through third-party reviews. This program supports better products and safer devices without adding extra costs or deadlines for companies. It’s all about encouraging excellence and teamwork between the FDA, industry, and partners like the Medical Device Innovation Consortium.
Previous / Next Documents
Previous: 2026-03852, Agency Information Collection Activity Under OMB Review: Intent To File a Claim for Compensation and/or Pension, or Survivors Pension and/or DIC
The VA is asking for public feedback on a form veterans use to say they plan to file for benefits like compensation or pension. This form helps set the start date for benefits, but no changes have been made to it—just more people are expected to use it. If you’re a veteran or survivor thinking about benefits, now’s the time to weigh in before March 30, 2026!
Next: 2026-03854, Notice and Request for Comment; Proposal for a New United Nations Global Technical Regulation on Automated Driving Systems (ADS)
The U.S. government wants your thoughts on a new global rule for self-driving cars to make sure they’re safe and work well. This affects car makers, tech companies, and anyone interested in automated driving. You’ve got until March 10, 2026, to share your ideas—no extra costs, just your voice helping shape the future of driving!