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Are design controls required in the following scenario?
A manufacturer lists its Class I centrifuges with FDA under the JQC product code. According to the FDA Product Classification Database (see:
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?ID=543), Class 1 - JQC centrifuges are GMP exempt ". . . except for general requirements concerning records (820.180) and complaint files (820.198) . . . ."
Nothwithstanding this GMP exemption statement by FDA,
21 CFR 820.30(a)(2)(i) on "Design Controls" states the following about Class I products:
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(a) General. (1) Each manufacturer of any class III or class II device, and the class I devices listed in paragraph (a)(2) of this section, shall establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met.
(2) The following class I devices are subject to design controls:
(i) Devices automated with computer software; and
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Because the aforementioned Class I- JQC centrifuge has a PC board that allows it to run software programs for preset speed and time of operation, one could reasonably presume the centrifuge is "automated with computer software" as stated in 21 CFR 820.30 and that design controls should be applied in an abundance of caution (N.B. FDA does not define "automated with computer software" anywhere).
However, the manufacturer is
confused by the FDA Product Classification Database when FDA claims Class I-JQC centrifuges are exempt from GMP -- with exceptions -- and then FDA
fails to include design controls in those stated exceptions!
Based on the foregoing. . .must this manufacturer subject their Class I - JQC centrifuges to design controls?
Thank you in advance for any guidance or input.