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3 extracted findings
FDA source excerpt, selected passage
Failure to establish and maintain procedures for validating the device design to ensure that devices conform to defined user needs and intended uses and include testing of production units under actual or simulated use conditions, and include risk analysis where appropriate, as required by, 21 CFR 820.30(g). Specifically,
Findings and supporting evidence
Model-assisted readings, not an exhaustive interpretation. Compare with the extracted source findings below.
Findings extracted from the letter
Selected FDA passages, not the complete letter.
01
Failure to establish and maintain procedures for validating the device design to ensure that devices conform to defined user needs and intended uses and include testing of production units under actual or simulated use conditions, and include risk analysis where appropriate, as required by, 21 CFR 820.30(g). Specifically,
Source passage selected by the model
02
Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a). For example:
Source passage selected by the model
03
Failure to submit a report to FDA no later than 30 calendar days after the day that your firm received or otherwise became aware of information, from any source, that reasonably suggests that a device that your firm markets may have caused or contributed to a death or serious injury, as required by 21 CFR 803.50(a)(1). For example:
Source passage selected by the model
Sections and clauses cited
As cited in this historical letter, not a statement of current regulatory requirements.