FDA Determines Review Period for TRICLIP Medical Device Patent Extension
Published Date: 9/29/2025
Notice
Summary
The FDA has officially set the review period for TRICLIP, a medical device, so its patent can be extended. This helps the company behind TRICLIP get extra time to protect their invention after going through the approval process. If you’re involved in medical devices or patents, this means important deadlines and opportunities to keep an invention exclusive for longer.
No Economic Impacts Identified for this Document
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.
2026-20441, Medical Devices; Cardiovascular Devices; Classification of the Hyperoxia Monitoring Device Adjunct to Pulse Oximetry
The FDA is officially putting the hyperoxia monitoring device that works with pulse oximeters into a safer, easier-to-manage category called Class II. This change, effective October 6, 2026, means the device will have special safety rules but fewer regulatory hurdles, helping patients get access to this cool tech faster. Medical device makers and healthcare providers will feel the impact, with smoother approval processes and no big new costs expected.
Previous / Next Documents
Previous: 2025-18780, Determination of Regulatory Review Period for Purposes of Patent Extension; DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE
The FDA has officially set the review period for the DIAMONDBACK 360 heart device, helping its makers extend their patent protection. This means the company can get extra time to keep their invention exclusive, which could impact when generic versions appear. If you’re in the medical device world, this timing update is a big deal for innovation and competition.
Next: 2025-18782, Agency Information Collection Activities; Proposed Collection; Comment Request; Extension: Rule 30e-3 (17 CFR 270.30e-3) Under the Investment Company Act of 1940, “Internet Availability of Reports to Shareholders”
The SEC is asking for comments to extend a rule that lets investment funds share important reports online instead of mailing paper copies. About 700 funds use this option, saving time and money while still giving investors easy access to info. The rule keeps costs around $5 million yearly and requires funds to notify investors and provide paper copies if asked.