🧬FDA Classifies Newborn Screening Test System Under Class II
The Food and Drug Administration (FDA, the Agency, or we) is classifying the lysosomal storage disorder newborn screening 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 lysosomal storage disorder newborn screening 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🏥HUD Eliminates Green MIP for Healthcare Facilities
On May 19, 2022, HUD proposed MIP reductions to achieve green and energy-efficiency buildings for FHA-insured loans on properties under specific Office of Healthcare insurance programs (the 2022 notice). This notice eliminates the Green and Energy Efficient MIP category for Healthcare Facilities, and all projects will be subject to the rate that had been previously established through Federal Register notice for such FHA-insured loans.
Learn More🚫DEA Revokes Registration of Dr. Bohdan Olesnicky
The Drug Enforcement Administration has revoked the DEA registration of Dr. Bohdan Olesnicky due to his lack of authority to practice medicine in California, following his voluntary surrender of his medical license. This action highlights the necessity for healthcare professionals to maintain state licensure to manage controlled substances legally under federal law.
Learn More📄FDA Issues Guidance on Conducting Remote Regulatory Assessments
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Conducting Remote Regulatory Assessments--Question and Answers." The final guidance describes FDA's current thinking regarding its use of remote regulatory assessments (RRAs) and provides answers to frequently asked questions. FDA has used RRAs to conduct oversight, mitigate risk, meet critical public health needs, and help evaluate compliance of FDA- regulated products with applicable regulatory requirements.
Learn More🏥FDA Revokes EUA for Cepheid COVID-19 Diagnostic Device
The Food and Drug Administration (FDA) is announcing the revocation of the Emergency Use Authorization (EUA) (the Authorization) issued to Cepheid for the Xpert Xpress SARS-CoV-2 test. FDA revoked the Authorization under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as requested by the Authorization holder. The revocation, which includes an explanation of the reason for revocation, is reprinted at the end of this document.
Learn More⚖️Temporary Scheduling of Benzimidazole-Opioids for Public Safety
The Acting Administrator of the Drug Enforcement Administration is issuing this notice of intent to publish a temporary order to schedule seven benzimidazole-opioid substances in schedule I of the Controlled Substances Act. When it is finalized, the temporary scheduling order will impose the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances on persons who handle (manufacture, distribute, reverse distribute, import, export, engage in research, conduct instructional activities or chemical analysis, or possess) or propose to handle these seven specified substances.
Learn More🏥OPM Seeks Comments on CAHPS Enrollee Survey Renewal
Healthcare and Insurance, Office of Personnel Management (OPM) offers the general public and other federal agencies the opportunity to comment on the administration of the Consumer Assessment of Healthcare Providers and Systems (CAHPS[supreg]) survey for the Federal Employees Health Benefits (FEHB) and the Postal Service Health Benefits (PSHB) Programs. CAHPS[supreg] surveys ask consumers and patients to report on and evaluate their experiences with health care. These surveys cover topics that are important to consumers and focus on aspects of quality that consumers are best qualified to assess, such as the communication skills of providers and ease of access to health care services.
Learn More💊FDA Notice on Regulatory Review Period for FILSPARI Patent Extension
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for FILSPARI 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🏥Notice on ACHC Hospice Accreditation Program and Public Comment
This proposed notice acknowledges the receipt of an application from the Accreditation Commission for Health Care, for continued recognition as a national accrediting organization for hospices that wish to participate in the Medicare or Medicaid programs.
Learn More🩺FDA Announces Regulatory Review Period for EDWARDS SAPIEN Device
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for EDWARDS SAPIEN 3 TRANSCATHETER PULMONARY VALVE 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 patents which claim that medical device.
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