TITLE 21 - FOOD AND DRUGS

CHAPTER I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER H - MEDICAL DEVICES

PART 820 - QUALITY SYSTEM REGULATION

subpart m - RECORDS

820.186 - Quality system record.

Each manufacturer shall maintain a quality system record (QSR). The QSR shall include, or refer to the location of, procedures and the documentation of activities required by this part that are not specific to a particular type of device(s), including, but not limited to, the records required by 820.20. Each manufacturer shall ensure that the QSR is prepared and approved in accordance with 820.40.