Opportunity
Federal Register #FDA-2026-N-12211
FDA medical-device classifications and EPA approval of an Arizona vehicle emissions-credit program
Buyer
Food and Drug Administration
Posted
November 05, 2026
Identifier
FDA-2026-N-12211
This notice reports regulatory actions by the FDA and EPA; it does not solicit products or services for purchase. - Government agencies: U.S. Department of Health and Human Services, Food and Drug Administration (FDA); and the Environmental Protection Agency (EPA). - FDA device classifications: - Prognostic assessment software for mild cognitive impairment is classified as a Class II prescription device with special controls. It combines clinical data to estimate the likelihood of progression to more severe cognitive impairment or dementia and is intended as an adjunct, not a standalone tool. No manufacturer is named. - A wearable orthopedic vibration device, the Osteoboost Belt, is classified as a Class II device with special controls. Bone Health Technologies, Inc. requested the classification. Controls include clinical testing with at least one year of follow-up, nonclinical performance testing, safety and usability evaluations, and labeling; the device type is also subject to 510(k) premarket notification requirements. - EPA action: Approved an Arizona State Implementation Plan revision establishing an emissions-reduction-credit program for retrofitted or replacement lower-emitting on-road vehicles. - No quantities, part numbers, contract value, or procurement performance period are specified.
Description
The FDA classifies wearable vibration devices for orthopedic use as class II devices subject to special controls. These wearable devices use mechanical vibrations targeted to specific regions of the skeleton to reduce loss of bone strength or bone mineral density. The final order establishes requirements including clinical and non-clinical performance testing, biocompatibility, safety and electromagnetic compatibility data, software analysis, usability evaluation, and labeling. The device is also subject to premarket notification requirements under section 510(k).