FDA Clocks Review Time for Gooey 'Chocolate Touch' Heart Balloon
Published Date: 7/2/2025
Notice
Summary
The FDA has set the official review period for CHOCOLATE TOUCH, a special medical balloon catheter coated with paclitaxel. This means the company can apply to extend their patent, giving them more time to protect their invention and possibly earn more money. If you’re in the medical device world, keep an eye on this patent extension process—it could affect competition and innovation timing.
Analyzed Economic Effects
2 provisions identified: 1 benefits, 0 costs, 1 mixed.
Patent Extension Application Allowed
The FDA determined the regulatory review period for CHOCOLATE TOUCH (a paclitaxel-coated PTA balloon catheter). The company that submitted the device can apply to the U.S. Patent and Trademark Office for an extension of a patent that claims this medical device, which would give the company more time to protect the invention.
May Affect Competition and Innovation Timing
The notice says the patent extension process for CHOCOLATE TOUCH could affect competition and the timing of innovation in the medical device world. Stakeholders in the medical device industry should watch the patent extension because it could change when competitors can enter the market.
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.
2026-16959, Frequently Asked Questions-Developing Potential Cellular and Gene Therapy Products; Final Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance titled "Frequently asked Questions--Developing Potential Cellular and Gene Therapy Products." The guidance document provides industry with answers to frequently asked questions (FAQs) and commonly faced issues that arise during the development of cellular and gene therapy (CGT) products. The FAQs represent common questions directed to the Agency and span multiple disciplines, including regulatory review; chemistry, manufacturing, and controls (CMC); pharmacology/toxicology; clinical; and clinical pharmacology. This guidance announced in this notice finalizes the draft guidance of the same title issued on November 19, 2024.
2026-16944, Gardenia Blue Interest Group; Filing of Color Additive Petition
The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by Gardenia Blue Interest Group (GBIG or petitioner), c/o Exponent, Inc., proposing that we amend our color additive regulations to expand the safe use of gardenia (genipin) blue in various foods at levels consistent with good manufacturing practice. The petition also proposes to lower the specification for arsenic in gardenia (genipin) blue.
2026-16942, Food Additives Permitted in Feed and Drinking Water of Animals; Chromium DL-methionine Chelate
The Food and Drug Administration (FDA, we, or the Agency) is amending the regulations for food additives permitted in feed and drinking water of animals to provide for the safe use of chromium DL- methionine chelate as a nutritional source of chromium in cattle feed. This action is in response to a food additive petition filed by Zinpro Corp.
Previous / Next Documents
Previous: 2025-12339, Determination of Regulatory Review Period for Purposes of Patent Extension; [TOTAL POSTERIOR SPINE SYSTEM (TOPS SYSTEM)]
The FDA has set the official review period for the TOTAL POSTERIOR SPINE SYSTEM (TOPS SYSTEM), a medical device. This helps the company extend its patent, giving them more time to protect their invention. If you’re in the medical or patent world, this means the device’s makers get extra time before others can copy it, potentially affecting market timing and profits.
Next: 2025-12341, Determination of Regulatory Review Period for Purposes of Patent Extension; WINREVAIR
The FDA has officially set the review period for WINREVAIR, a medicine that helps people breathe better. This means the company can ask for extra time on their patent to protect their invention. If approved, this extension could give them more years to sell WINREVAIR without competition, which might affect when generic versions can appear.