FDA Issues Guidance on Certain Ophthalmic Products: Policy for Compliance with 21 CFR Part 4

March 22, 2022

The U.S. Food and Drug Administration today issued the guidance for industry, Certain Ophthalmic Products: Policy Regarding Compliance With 21 CFR Part 4. This guidance provides information to applicants and manufacturers of certain ophthalmic drugs packaged together with ophthalmic dispensers that the agency now intends to regulate these products as drug-led combination products.

FDA is issuing this guidance as a result of the District of Columbia Circuit Court’s decision in Genus Medical Technologies LLC v. U.S. Food and Drug Administration, where the court stated “[e]xcepting combination products, . . . devices must be regulated as devices and drugs --- if they do not also satisfy the device definition --- must be regulated as drugs.”

Before the Genus decision, the agency regulated ophthalmic dispensers as drugs when they were packaged together with ophthalmic drugs. However, in implementing Genus, the agency determined the ophthalmic dispensers meet the FD&C Act’s definition of a device and concluded that the language in 21 CFR 200.50(c) indicating that ophthalmic dispensers are regulated as drugs when packaged with ophthalmic drugs is obsolete. Therefore, FDA intends to regulate these products as drug-led combination products.  Because the drug constituent part provides the primary mode of action, generally FDA’s Center for Drug Evaluation and Research will have primary jurisdiction over these products.

As a result of this change, these products are now subject to the applicable combination product current good manufacturing practice (CGMP) requirements and applicable combination product postmarketing safety reporting requirements. Therefore, we are issuing this guidance to communicate the agency’s compliance policy with respect to these products. Specifically, the guidance explains that

  1. FDA understands some companies may have to develop policies and procedures to comply with these requirements. Thus, for a period of 12 months following the publication of the guidance, FDA generally does not intend to take action with respect to noncompliance with the device quality system regulation (QSR) requirements as described in the combination product CGMP regulations or the combination product postmarketing safety reporting requirements, with respect to ophthalmic products that were not previously regulated as combination products because of the now obsolete language in § 200.50(c).
  2. With respect to ophthalmic products affected by the Genus decision that incorporate lower-risk device constituent parts, for example, eye dropper bottles/ampules that administer the drug directly to the eye, FDA does not intend to take action with respect to noncompliance with any applicable device QSR requirements until FDA further considers the application of these requirements to these combination products.

Additionally, the guidance describes FDA’s policy with respect to pending applications and how FDA will determine when compliance with the requirements of part 4, subpart A, must be demonstrated (i.e., during the review of the application or after approval).

See the guidance for more details.

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