Biometric subsystem

Biometric subsystem means the hardware and software used to capture, store, and compare biometric data. The biometric subsystem may be part of a larger application. The biometric subsystem is an automated system capable of:
(1) Capturing a biometric sample from an end user.
(2) Extracting and processing the biometric data from that sample.
(3) Storing the extracted information in a database.
(4) Comparing the biometric data with data contained in one or more reference databases.
(5) Determining how well the stored data matches the newly captured data and indicating whether an identification or verification of identity has been achieved.

Source

21 CFR § 1300.03


Scoping language

For the purposes of this chapter, the following terms shall have the meanings specified:

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