FDA approved devices need be manufactured by FDA approved manufacturers.
Mfr must have FDA Establishment Identification number. An FDA Establishment Identification (FEI) number is a unique identifier issued by FDA to track inspections of the regulated establishment or facility.
FDA assessors and inspectors determine whether the firm has the necessary facilities, equipment, and ability to manufacture the device it intends to market and carry FDA approval language.
CGMP Current Good Management Practices
VYST is doing things right, step by step. Patience.