Statements (49)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
gptkb:legislation
|
| gptkbp:alsoKnownAs |
gptkb:Quality_System_Regulation
|
| gptkbp:appliesTo |
medical device manufacturers
medical device importers medical device distributors |
| gptkbp:codifiedIn |
gptkb:Title_21_of_the_Code_of_Federal_Regulations
|
| gptkbp:countryOfOperation |
gptkb:United_States
|
| gptkbp:enforcedBy |
gptkb:FDA_Center_for_Devices_and_Radiological_Health
|
| https://www.w3.org/2000/01/rdf-schema#label |
FDA 21 CFR Part 820
|
| gptkbp:issuedBy |
gptkb:U.S._Food_and_Drug_Administration
|
| gptkbp:legalCitation |
21 CFR 820
|
| gptkbp:noncomplianceMayResultIn |
gptkb:crime
civil penalties product recalls injunctions seizure of products warning letters import detentions |
| gptkbp:purpose |
establish quality system requirements for medical devices
|
| gptkbp:relatedTo |
gptkb:ISO_13485
|
| gptkbp:requires |
internal audits
personnel training documented procedures management responsibility corrective and preventive actions handling, storage, distribution, and installation controls design controls labeling and packaging controls production and process controls records and documentation |
| gptkbp:section |
gptkb:Subpart_A_-_General_Provisions
Subpart B - Quality System Requirements Subpart C - Design Controls Subpart D - Document Controls Subpart E - Purchasing Controls Subpart F - Identification and Traceability Subpart G - Production and Process Controls Subpart H - Acceptance Activities Subpart I - Nonconforming Product Subpart J - Corrective and Preventive Action Subpart K - Labeling and Packaging Control Subpart M - Records Subpart O - Statistical Techniques Subpart L - Handling, Storage, Distribution, and Installation |
| gptkbp:startDate |
June 1, 1997
|
| gptkbp:subjectOf |
FDA inspections
|
| gptkbp:updated |
FDA Quality Management System Regulation (QMSR) rule (proposed 2022)
|
| gptkbp:bfsParent |
gptkb:Arena_QMS
|
| gptkbp:bfsLayer |
7
|