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etrin62

08/26/20 3:17 PM

#145087 RE: Finsman99 #145084

Probably because of the device's certification to be used in the medical environment.

Hook

08/26/20 3:42 PM

#145090 RE: Finsman99 #145084

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.

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