FDA reclassifies non-invasive bone growth stimulators (product codes LOF and LPQ) from class III to class II devices, requiring premarket notification and establishing special controls for safety and effectiveness.
FAA amendments establish or revise Standard Instrument Approach Procedures and Obstacle Departure Procedures at various airports to reflect navigational facility changes and airspace system updates.
FDA's Pharmacy Compounding Advisory Committee will hold a public meeting to advise on bulk drug substances for inclusion in the Section 503A list, with a public docket open for comments.
The Committee proposes adding and removing products and services from the Procurement List for nonprofit agencies employing blind and severely disabled workers.
The Procurement List removes products formerly supplied by nonprofit agencies employing blind or severely disabled workers.
TSA requests public comment on revisions to its cybersecurity information collection (OMB control 1652-0074) requiring surface transportation modes to designate cybersecurity coordinators, report incidents, and complete assessments.
FDA classifies transcutaneous electrical nerve stimulators for congestion relief as class II devices subject to special controls to ensure safety and effectiveness while reducing regulatory burden.
FDA classifies manual surgical instruments for orthopedic implant patient selection as Class II medical devices, requiring special controls to ensure safety and effectiveness while reducing regulatory burden on manufacturers.
FDA approved AREXVY respiratory syncytial virus vaccine under the rare pediatric disease priority review voucher program on June 7, 2024, enabling the sponsor to redeem a voucher for expedited review of a future application.
FDA approves MRESVIA (Respiratory Syncytial Virus Vaccine) on May 31, 2024, redeeming a material threat medical countermeasure priority review voucher under the FD&C Act.
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