Subpart A. Subpart A—Current Good Manufacturing Practice Requirements for Combination Products

• § 4.1 - What is the scope of this subpart?
• § 4.2 - How does FDA define key terms and phrases in this subpart?
• § 4.3 - What current good manufacturing practice requirements apply to my combination product?
• § 4.4 - How can I comply with these current good manufacturing practice requirements for a co-packaged or single-entity combination product?