Contents Subpart A—Scope—Who Must Comply With These Rules? § 7.1 Who must comply with these rules? Subpart B—Definitions § 7.3 Definitions. Subpart C—Obligations—What Must Covered Entities Do? § 7.5 General Obligations. § 7.7 Product design, development, and evaluation. § 7.9 Information pass through. § 7.11 Information, documentation, and training. Subpart D—Enforcement § 7.15 Generally. § 7.16 Informal or formal complaints.