⚗️FDA Classification of Anti-Mullerian Hormone Test System
The Food and Drug Administration (FDA, the Agency, or we) is classifying the anti-mullerian hormone test system 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 the anti-mullerian hormone test system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of 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.
Learn More📄FDA's Draft Guidance for Electronic Submission of Medical Device Q-Submissions
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Electronic Submission Template for Medical Device Q-Submissions." FDA is issuing this draft guidance to introduce submitters of certain Q-Submissions (Q-Subs), specifically Pre-Submissions (Pre-subs) to the Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER), to the current resources and associated content developed and made publicly available to support Pre-Sub electronic submissions to FDA. This draft guidance, when finalized, is intended to represent one of several steps in meeting FDA's commitment to the development of electronic submission templates to serve as guided submission preparation tools for industry to improve submission consistency and enhance efficiency in the review process. This draft guidance is not final nor is it for implementation at this time.
Learn More🧬FDA Classifies Inherited Nucleotide Repeat Disorder DNA Test
The Food and Drug Administration (FDA, Agency, or we) is classifying the inherited nucleotide repeat disorder DNA test 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 the inherited nucleotide repeat disorder DNA test's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of 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.
Learn More🍖FDA Confirms Myoglobin Color Additive Regulations for 2025
The Food and Drug Administration (FDA or we) is confirming the effective date of February 19, 2025, for the final order that appeared in the Federal Register of January 17, 2025. The final order amends the color additive regulations to provide for the safe use of myoglobin as a color additive in ground meat and ground poultry analogue products.
Learn More💊FDA Guidance on Medical Device Submission Feedback Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled "Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program." This guidance document provides an overview of the mechanisms available to submitters through which they can request interactions with FDA related to medical device submissions. This guidance supersedes the document entitled "Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program" issued on June 2, 2023, and provides clarification and additional information on the scope of Q-Submission (Q-Sub) types, better delineation of how to obtain feedback for different types of questions (i.e., informal communication vs. Pre-Submission or other Q-Sub types), and improved examples.
Learn More🧪FDA Classifies Zika Virus Serological Reagents to Class II
The Food and Drug Administration (FDA, Agency, or we) is classifying the Zika virus serological reagents 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 the Zika virus serological reagents' classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of 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.
Learn More⚙️FDA Classifies Temporarily-Placed Urethral Opening System
The Food and Drug Administration (FDA, Agency, or we) is classifying the temporarily-placed urethral opening system for symptoms of benign prostatic hyperplasia 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 the temporarily- placed urethral opening system for symptoms of benign prostatic hyperplasia's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of 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.
Learn More🩺FDA Classifies Plazomicin Test System as Class II Device
The Food and Drug Administration (FDA, Agency, or we) is classifying the plazomicin test system 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 the plazomicin test system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of 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.
Learn More📡FCC Seeks Comments on Information Collection for MedRadio Services
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995, the Federal Communications Commission (FCC or Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collections. Comments are requested concerning: whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection burden on small business concerns with fewer than 25 employees. The FCC may not conduct or sponsor a collection of information unless it displays a currently valid OMB control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.
Learn More⚖️Investigation into Balloon Dilation Device Patent Infringement Announced
Notice is hereby given that a complaint was filed with the U.S. International Trade Commission on April 18, 2025, under section 337 of the Tariff Act of 1930, as amended, on behalf of Entellus Medical, Inc. of Plymouth, Minnesota, Stryker Corporation of Portage, Michigan, and Stryker Sales, LLC of Portage, Michigan. Supplements to the complaint were filed on April 25 and May 8, 2025. The complaint, as supplemented, alleges violations of section 337 based upon the importation into the United States, the sale for importation, and the sale within the United States after importation of certain balloon dilation devices, systems, and components thereof by reason of the infringement of certain claims of U.S. Patent No. 11,083,878 ("the '878 patent"); U.S. Patent No. 11,090,472 ("the '472 patent"); and U.S. Patent No. 12,274,847 ("the '847 patent"). The complaint further alleges that an industry in the United States exists or is in the process of being established as required by the applicable Federal Statute. The complainants request that the Commission institute an investigation and, after the investigation, issue a limited exclusion order and cease and desist orders.
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