FDA Classifies Surgical Angle Tool as Moderate Risk
Published Date: 7/24/2026
Rule
Summary
The FDA is officially putting the intraoperative surgical angle measurement tool into Class II, meaning it now has special safety rules but fewer red tape hurdles. This change helps make sure the tool is safe and effective while speeding up patient access to cool new tech. It affects device makers and hospitals, with the new rules effective July 24, 2026, and no big cost surprises expected.
Analyzed Economic Effects
4 provisions identified: 2 benefits, 2 costs, 0 mixed.
Device moved to Class II
The FDA officially classified the intraoperative surgical angle measurement tool as Class II (special controls). This classification is effective July 24, 2026 (and was applicable July 14, 2023) and is intended to reduce regulatory burden and enhance patients' access to this type of device.
Premarket 510(k) required
The intraoperative surgical angle measurement tool is subject to premarket notification under section 510(k) of the FD&C Act. Device sponsors and manufacturers must submit a 510(k) premarket notification to market this class II device.
New special-control testing and labeling
Manufacturers must meet specific special controls: non-clinical performance testing (system and procedural accuracy), usability testing, biocompatibility of patient-contacting parts, sterility and shelf-life testing, software verification/validation and hazard analysis, electrical/electromagnetic/wireless testing, and detailed labeling including device technical parameters, accuracy/precision, reprocessing instructions, limitations, and shelf-life.
De Novo creates predicate for future devices
Because FDA classified this device via the De Novo process, the intraoperative surgical angle measurement tool can serve as a predicate device for future devices of the same type, allowing future sponsors to use the less-burdensome 510(k) pathway instead of De Novo or premarket approval.
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.
2026-18432, Medical Devices; Cardiovascular Devices; Classification of the Temperature Regulation Device for Esophageal Protection During Cardiac Ablation Procedures
The Food and Drug Administration (FDA) is classifying the temperature regulation device for esophageal protection during cardiac ablation procedures into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the temperature regulation device for esophageal protection during cardiac ablation procedures. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of the safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
2026-18426, Medical Devices; General Hospital and Personal Use Devices; Classification of the Whole Room Microbial Reduction Device
The Food and Drug Administration (FDA) is classifying the whole room microbial reduction device into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the whole room microbial reduction device. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of the safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
2026-18433, Medical Devices; Cardiovascular Devices; Classification of the Mechanical Deviation Device for Esophageal Protection During Cardiac Ablation Procedures
The FDA is officially classifying a new device that protects the esophagus during heart procedures as a Class II device, meaning it’s safe and effective with some special rules. This change helps patients get access to this cool innovation faster by cutting down on red tape. The new classification took effect on September 10, 2026, but has been in place since September 6, 2023, making it easier and potentially cheaper for makers to bring this device to market.
Previous / Next Documents
Previous: 2026-14986, Medical Devices; General Hospital and Personal Use Devices; Classification of the Diabetes Digital Behavioral Therapeutic Device
The FDA has officially placed the diabetes digital behavioral therapeutic device into Class II, meaning it now has special safety rules but fewer regulatory hurdles. This change helps patients get access to this innovative device faster and ensures it’s safe and effective. The new classification took effect on July 24, 2026, with benefits starting from July 7, 2023, making it easier and potentially cheaper for makers to bring these devices to market.
Next: 2026-14988, Safety Zones; Annual Events in the Captain of the Port Eastern Great Lakes Zone; Correction
The Coast Guard fixed a date mix-up for the Hamburg Beach Blast safety zone in the Eastern Great Lakes. Instead of July 26, the event’s safety zone will be enforced on July 25, 2026. This update helps boaters and event-goers plan safely without surprises—no extra costs, just clearer info!