Contents Subpart A—Scope—Who Must Comply With These Rules? § 6.1 Applicability. Subpart B—Definitions § 6.3 Definitions. Subpart C—Obligations—What Must Covered Entities Do? § 6.5 General obligations. § 6.7 Product design, development, and evaluation. § 6.9 Information pass through. § 6.11 Information, documentation, and training. Subpart D—Enforcement § 6.15 Generally. § 6.16 Informal or formal complaints.