FDA Places Bacillus Protein Test Into Class II
Published Date: 6/22/2026
Rule
Summary
The FDA is officially putting a simple test that spots proteins from Bacillus bacteria in human samples into a safer, easier-to-manage category called Class II. This change helps make sure the test is safe and works well while speeding up patient access to cool new medical tools. The new rules kicked in on June 22, 2026, but have been in effect since February 3, 2023, making life simpler for device makers and patients alike.
Analyzed Economic Effects
5 provisions identified: 2 benefits, 2 costs, 1 mixed.
Design Verification and Clinical Study Rules
FDA requires manufacturers to provide detailed design description and documentation of analytical studies (e.g., limit of detection, inclusivity, cross-reactivity) and clinical studies or equivalent data sets comparing performance to an FDA-appropriate reference method (see 21 CFR 866.3046(b)(4)).
Class II Reclassification Speeds Access
The FDA classified the simple in vitro diagnostic test for detecting secreted proteins from Bacillus species into Class II (special controls). The agency says this Class II classification provides reasonable assurance of safety and effectiveness and will enhance patient access and reduce regulatory burdens; the order is effective June 22, 2026 (and was applicable on February 3, 2023).
Premarket 510(k) Requirement Remains
FDA stated that simple IVDs for detection of secreted proteins from Bacillus spp. are subject to premarket notification under section 510(k) and have not been exempted under section 510(m). Manufacturers must submit a 510(k) to market these Class II devices.
Prescription-Only and Lab Distribution Limits
FDA says these simple Bacillus-protein IVDs are prescription in vitro diagnostic devices and limits their distribution to laboratories that follow public health biosafety guidelines. The labeling must include statements that testing is for presumptive identification and that results require confirmation and reporting to public health authorities.
Detailed Labeling Requirements Imposed
The final order lists extensive labeling requirements that manufacturers must include (e.g., intended use details, sample types, population, warnings that results are presumptive, instructions to minimize exposure and contamination, and reporting instructions). These labeling requirements are codified at 21 CFR 866.3046(b)(3).
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
2026-14073, 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.
2026-15920, Micro-Tracers, Inc.; Response to Objections and Requests for a Public Hearing
The Food and Drug Administration (FDA or we) received objections and requests for a public hearing submitted by Buchanan Ingersoll & Rooney PC, on behalf of Micro-Tracers, Inc. (Micro-Tracers or objector), on the order granting a color additive petition (3C0323) requesting that we repeal specified regulations to no longer provide for the safe use of FD&C Red No. 3 in food (including dietary supplements) and ingested drugs. After reviewing the objections, we have concluded that the objections do not raise issues of material fact that justify a hearing. We are also providing notice that the administrative stay of the effective date for the repeal and delisting of the color additive regulations is now lifted.
2026-15613, Assessing Adhesion With Transdermal and Topical Delivery Systems for ANDAs; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry titled "Assessing Adhesion With Transdermal and Topical Delivery Systems for ANDAs." This guidance provides recommendations for the design and conduct of studies evaluating the adhesion performance of a transdermal or topical delivery system (collectively referred to as TDS). Depending on the objectives of a generic TDS product development program, applicants may choose to evaluate TDS adhesion in studies performed to evaluate TDS adhesion only, or in studies performed with a combined purpose (e.g., for the simultaneous evaluation of adhesion and bioequivalence (BE) with pharmacokinetic (PK) endpoints). The recommendations in this guidance relate to studies submitted in support of an abbreviated new drug application (ANDA). The guidance replaces the draft guidance (Revision 2) "Assessing Adhesion With Transdermal and Topical Delivery Systems for ANDAs," issued on April 13, 2023.
2026-15635, Angela Anatilde Baquero: Final Debarment Order
The Food and Drug Administration (FDA or the Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) permanently debarring Angela Anatilde Baquero from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Angela Anatilde Baquero was convicted of a felony under Federal law for conduct relating to the development or approval, including the process for development or approval, of any drug product. Mrs. Baquero was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. As of May 6, 2026 (30 days after receipt of the notice), Mrs. Baquero has not responded. Mrs. Baquero's failure to respond and request a hearing constitutes a waiver of Mrs. Baquero's right to a hearing concerning this matter.
2026-15612, Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs; Revised Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry titled "Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs." This revised draft guidance provides recommendations for the design and conduct of studies to evaluate the in vivo skin irritation (and sensitization, if applicable) potential of a proposed transdermal or topical delivery system (collectively referred to as TDS). The recommendations in this revised draft guidance relate to studies submitted in support of an abbreviated new drug application (ANDA). The revised draft guidance is intended to clarify FDA's recommendations and expectations related to in vivo skin irritation and in vivo combined skin irritation and sensitization studies. This draft guidance replaces the draft guidance "Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs" (April 2023).
Previous / Next Documents
Previous: 2026-12432, Safety Zone; Offshore, Ritidian Point, GU
The Coast Guard is setting up a temporary safety zone in the waters off Ritidian Point, Guam, from June 30 to July 1, 2026. This zone keeps boats and people out during a big missile defense exercise to keep everyone safe. If you want to enter, you’ll need special permission, but no extra costs or long delays are expected.
Next: 2026-12444, Medical Devices; Gastroenterology-Urology Devices; Classification of the Endoscopic Light-Projecting Measuring Device
The FDA is officially putting the endoscopic light-projecting measuring device into Class II, meaning it now has special safety rules but fewer hurdles than the strictest category. This change helps make sure the device is safe and effective while speeding up patient access to cool new tech. The new rules took effect June 22, 2026, and could save time and money for makers and users alike.