FDA CDRH ODE PMA Manual Software Excerpts

Obsoleted by FDAFDA CDRH Office of Device Evaluation’s “PMA Manual” mentions software intormation in several places. The first is in the equipment section of an application:
“4. If computers are used as part of an automated production or quality assurance system, provide validation protocols for the software and, if available, the validation records and conclusions.”

The second is regarding the software in the device itself:

“O. Devices Containing Software

1. Provide a copy of the procedures for the acceptance of software, and the specifications for
the software.

2. Provide a copy of the procedures for software handling, storage, and environmental

3. Provide a copy of the procedures for software change or revision control.

4. Provide a copy of the procedure used for software duplication, and the procedure used to
assure that the program is accurately copied.

5. Provide a copy of the procedure used for validating revisions of the original software.”

The third is where it specifically states that the Special PMA Supplement is not appropriate for software changes in the device:

“In addition, I would like to remind you that the provision for a “Special PMA Supplement -Changes Being Effected” is limited to the labeling, quality control and manufacturing process changes specified under 21 CFR 814.39(d)(2). It allows for the addition of, but not the replacement of, previously approved quality control specifications and test methods. These changes may be implemented before FDA approval upon acknowledgment by FDA that the submission is being processed as a “Special PMA Supplement – Changes Being Effected.” This acknowledgment is in addition to that issued by the PMA Document Mail Center for all PMA supplements submitted. This procedure is not applicable to changes in device design, composition, specifications, circuitry, software, or energy source.”

The entire PMA manual can be obtained at the link above.

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