PMA requires everything noted under ‘requirements’ in 510(K), along with information regarding manufacturing:
- Critical/non-critical device status
- Organization (sufficient to describe QA program including training)
- QA program
- Quality audits (written quality audit procedures)
- Facilities (description, procedures, rationales)
- Equipment (list of equipment, general calibration procedure, examples of calibration records)
- Methods to control components
- Production and process controls (process flow and production procedures, identification and validation of significant processes and testing procedures)
