Description
This compliance policy guide provides FDA’s policy on use of consensus standards for compliance and premarket clearance.
Key Topics
Terms and concepts identified from this document
Scope & Applicability
Product Classes
2Sphygmomanometers
Specific type of blood pressure measurement device
Blood Pressure Measurement Devices
Subject of the Compliance Policy Guide
Stakeholders
2Industry
Guidance for Industry
FDA Staff
One of the primary audiences for this guidance document.
Regulatory Context
Attributes
1Accuracy
Performance characteristic assessed via linearity experiment
Related MFDS Guidelines
Korean regulatory guidelines covering similar topics
See Also (8)
- CPG Sec. 350.100 Packaging Technologies and Tamper-Resistant Packaging Requirements for Contact Lens Solutions and Tablets
- CPG Sec. 325.100 Karaya Gum Powder and Related Devices for Use by Ostomates
- CPG Sec. 345.200 Diaphragms - Rx Devices
- CPG Sec. 300.600 Commercial Distribution with Regard to Premarket Notification (Section 510(k))
- CPG Sec. 320.100 Ear Piercing Devices
- CPG Sec. 300.100 Inspection of Manufacturers of Device Components
- CPG Sec. 398.450 Applicability of Positive Beam Limitation (PBL) Requirements When PBL is Provided on "Other than Stationary General Purpose" Radiographic System
- CPG Sec. 335.800 Clinical Thermometer - Adulteration; Misbranding Defects