FDA Plans Testing for Medical Device Communication Clarity

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.

2026-13346 — Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medication Guides for Prescription Drug Products

The FDA is updating how it collects info about Medication Guides—those important leaflets that come with some prescription drugs to keep patients safe. This affects drug makers who must follow new rules about what info to include and how to share it. Comments on these changes are open until July 31, 2026, and the update aims to keep patients informed without adding extra costs.

2026-13140 — Medical Devices; Anesthesiology Devices; Classification of the Monitor for Opioid Induced Impairment of Oxygenation

The FDA is officially putting the monitor for opioid-induced oxygen problems into a safer, easier-to-manage category called Class II. This change helps make sure the device works well and is safe, while also speeding up patient access to this important tech. The new rules took effect on June 30, 2026, and could lower costs and delays for companies making these monitors.

2026-13139 — Medical Devices; General and Plastic Surgery Devices; Classification of the Skin Patch for Treatment of Hyperhidrosis

The FDA is officially classifying the skin patch that treats excessive sweating (hyperhidrosis) as a Class II device, meaning it has special safety rules but fewer hurdles than the strictest category. This change helps patients get access to this cool new treatment faster and safer, starting June 30, 2026. Companies making these patches will find it easier and less costly to bring their products to market.

2026-13006 — Determination of Regulatory Review Period for Purposes of Patent Extension; VYALEV

The FDA has officially set the review period for the drug VYALEV, which helps the company extend its patent protection. This means the patent clock can be paused, giving the drug maker more time to sell VYALEV exclusively. If anyone thinks the dates are wrong or the company wasn’t diligent, they can speak up by late 2026.

2026-13005 — Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; New Animal Drugs for Minor Use and Minor Species

The FDA is asking for public feedback on their plan to keep collecting info about new animal drugs for rare uses and less common species. This affects drug makers who want special approval and incentives for these unique animal medicines. Comments are open until July 29, 2026, and the process helps keep these important drugs safe and available without extra costs.

Previous: 2026-09243 — Certain Photodynamic Therapy Systems, Components Thereof, and Pharmaceutical Products Used in Combination With the Same; Notice of the Commission's Final Determination Finding a Violation of Section 337; Issuance of a Limited Exclusion Order and Cease and Desist Orders; Termination of the Investigation

The U.S. International Trade Commission found that some photodynamic therapy devices and related products imported by certain companies broke patent rules. To fix this, they’re blocking these products from entering the U.S. without permission and ordering the companies to stop selling them. This means affected businesses must act fast or face legal and financial consequences.

Next: 2026-09245 — World Trade Center Health Program; Petitions 032, 033, and 068-Peripheral Neuropathy; Finding of Insufficient Evidence

The World Trade Center Health Program reviewed requests to add peripheral neuropathy as a covered health condition but found not enough proof to do so. This means people affected by 9/11 won’t see changes to their benefits for this condition right now. The decision was made official on May 11, 2026, with no new costs or coverage updates planned.