🍽️FDA Seeks Comments on Manufactured Food Regulatory Program Standards
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the collection of information associated with our Manufactured Food Regulatory Program Standards (MFRPS).
Learn More💊FDA Determines Regulatory Review Period for VOYDEYA Patent Extension
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for VOYDEYA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Learn More💊FDA Notice on Patent Extension for VAFSEO Drug Regulations
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for VAFSEO and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Learn More🌡️FDA Exempts Class II Clinical Electronic Thermometers from Regulations
The Food and Drug Administration (FDA, we, or the Agency) is publishing an order setting forth the Agency's final determination to exempt certain class II clinical electronic thermometers from premarket notification (510(k)) requirements, subject to certain limitations. This exemption from 510(k), subject to certain limitations, is immediately in effect for such class II clinical electronic thermometers. This exemption will decrease regulatory burdens on the medical device industry and will eliminate private costs and expenditures required to comply with Federal regulations. FDA is amending the classification language within the Code of Federal Regulations for certain class II clinical electronic thermometers to reflect this final determination. FDA is publishing this order in accordance with the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Learn More🚬FDA Notice on Modified Risk Tobacco Products for ZYN by Swedish Match
The Food and Drug Administration (FDA or Agency) is announcing an opportunity to provide public comment on modified risk tobacco product applications (MRTPAs) submitted by Swedish Match U.S.A., Inc. for ZYN oral pouch products containing nicotine derived from tobacco.
Learn More🧀FDA Permits Market Testing of Innovative Cheese Product
The Food and Drug Administration (FDA or we) is announcing an amendment to the temporary permit issued to Bongards' Creameries to market test pasteurized process cheese deviating from the standard of identity for these cheeses by using extra virgin olive oil as the slice anti-sticking agent. We are also announcing an extension to this permit, which allows Bongards' Creameries to continue to evaluate commercial viability of the product and to collect data on consumer acceptance of the product in support of a petition to amend the standard of identity. We invite other interested parties to participate in the market test.
Learn More🏥FDA Seeks Nominations for Consumer Representatives on Advisory Committees
The Food and Drug Administration (FDA or the Agency) is requesting that any consumer organizations interested in participating in the selection of voting and/or nonvoting consumer representatives to serve on its advisory committees or panels notify FDA in writing. FDA is also requesting nominations for voting and/or nonvoting consumer representatives to serve on advisory committees and/or panels for which vacancies currently exist or are expected to occur in the near future. Nominees recommended to serve as a voting or nonvoting consumer representative may be self-nominated or may be nominated by a consumer organization. FDA seeks to include the views of individuals on its advisory committee selected without regard to race, color, national origin, religion, age, or sex.
Learn More🦠FDA Classifies Antimicrobial Susceptibility Testing Device as Class II
The Food and Drug Administration (FDA, the Agency, or we) is classifying the cellular analysis system for multiplexed antimicrobial susceptibility testing 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 cellular analysis system for multiplexed antimicrobial susceptibility testing'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 Final Order on Radiological Computer-Assisted Detection Devices
The Food and Drug Administration (FDA, the Agency, or we) is classifying the radiological computer-assisted detection and diagnosis software 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 radiological computer-assisted detection and diagnosis software'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 Pediatric Advisory Committee Meeting Notice for Public Comments
The Food and Drug Administration (FDA or the Agency) announces a forthcoming public advisory committee meeting of the Pediatric Advisory Committee (PAC). The general function of the committee is to provide advice and recommendations to FDA on pediatric regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
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