Description
This guidance is intended to provide information to applicants and manufacturers regarding compliance with the requirements in part 4 (21 CFR part 4) for ophthalmic drugs packaged with eye cups, eye droppers, or other dispensers. This guidance applies to products with pending applications, approved products, and products marketed pursuant to section 505G of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355h) without an approved application under section 505 of the FD&C Act (21 U.S.C. 355) (commonly referred to as over-the-counter (OTC) monograph drugs).
Scope & Applicability
Product Classes
2Over-the-counter drugs subject to section 505G; manufacturers of over-the-counter monograph drugs should follow recommendations; drugs not approved under section 505 or 351
Products combining drug, device, or biological constituents; Generally recommended for Enhanced Documentation; Requires 14971-based framework incorporating ICH Q9; A drug-device combination where the device constituent part detects ingestion.
Stakeholders
2Entity submitting development data and knowledge; Entity performing the work process for change
Entity responsible for submitting NDINs
Regulatory Context
Attributes
1determines the level of regulatory assessment
Related CFR Sections (4)
- 21CFR4.101§ 4.101 How does the FDA define key terms and phrases in this subpart?
Abbreviated new drug application (ANDA) has the same meaning given the term “abbreviated application” in § 314.3(b) of this chapter .Read full regulation →
- 21CFR200.50§ 200.50 Ophthalmic preparations and dispensers.
- 21CFR3.2§ 3.2 Definitions.
For the purpose of this part:Read full regulation →
- 21CFR10.115§ 10.115 Good guidance practices.
(a) What are good guidance practices? Good guidance practices (GGP's) are FDA's policies and procedures for developing, issuing, and using guidance documents.Read full regulation →
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See Also (8)
- Content of Premarket Submissions for Device Software Functions: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- CPG Sec. 300.600 Commercial Distribution with Regard to Premarket Notification (Section 510(k)) (Status: Final)
- CPG Sec. 350.100 Packaging Technologies and Tamper-Resistant Packaging Requirements for Contact Lens Solutions and Tablets (Status: Final)
- CPG Sec. 310.100 Pacemaker Reuse (Status: Final)
- Hysteroscopic and Laparoscopic Insufflators: Submission Guidance for a 510(k) (Status: Final)
- Kit Certification for 510(k)s (Status: Final)
- Immunotoxicity Testing Guidance (Status: Final)
- Inspection and Field Testing of Radiation-Emitting Electronic Products: Attachment C: Specific Instructions for Sunlamp Product Inspections and Tests (Status: Final)