As a manufacturer that presently has a registered ISO 13485:2003 quality management system and is also compliant to CFR 21 Part 820, what types of existing HC Recognized Registrar audits or existing FDA AP inspections are acceptable under the PMAP?

Annual HC Recognized Registrar surveillance audits and 3-year re-registration audits, as well as FDA AP inspections that follow the Level I or Level II Quality System Inspection Technique (QSIT), are acceptable under the PMAP.

HC Recognized Registrar related audits that are not acceptable would include:

1. Initial ISO 13485:2003 registration audits under CMDCAS;
2. Transfer of registration from one AO to another;
3. Upgrades to ISO 13485:2003;
4. Audits to support an extension to the existing scope of registration;
5. Special “for cause” audits. (For cause audits would be non-routine audits performed by the AO that are intended to address a serious concern the AO may have about the manufacturer.)