FDA shifts classification of some ophthalmic products to comply with Genus decision
The US Food and Drug Administration (FDA) has released a final guidance for industry that clarifies a change in classifying some ophthalmic products based on a court decision in Genus Medical Technologies LLV v. FDA (Genus).In April 2021, the US Court of Appeals for the District of Columbia Circuit ruled against FDA in the case and stated in its decision that “[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.” FDA had signaled to stakeholders and the public in August 2021 that the implications of the Genus decision meant it would soon start reclassifying some products approved as drugs to be regulated as devices (RELATED: After court defeat, FDA shifts to regulating some drugs as devices, Regulatory Focus 9 August 2021).
The latest guidance concerns 21 CFR Part 4, which defines regulation of combination products, and how it relates to “ophthalmic drugs packaged with eye cups, eye droppers, or other dispensers.” While these products historically did not fall under the purview of 21 CFR Part 4, FDA is now regulating these ophthalmic dispensers packaged with ophthalmic drugs as drug-led combination products, rather than drugs, to comply with the Genus decision, the agency noted. Ophthalmic dispensers that were regulated as devices and packaged with an ophthalmic drug are now considered device constituent parts, the agency said. The reclassification affects all products in this space, including those with pending applications, approvals, and over-the-counter monograph drugs.
“In implementing this decision, FDA has determined that the language in § 200.50(c) indicating that ophthalmic dispensers are regulated as drugs when packaged with ophthalmic drugs is now obsolete, because these articles meet the device definition,” the agency wrote in the guidance. “Therefore, FDA intends to regulate these products as drug-led combination products composed of a drug constituent part that provides the primary mode of action and a device constituent part (an ophthalmic dispenser).”
FDA said it will not act against applicants and manufacturers for a period of 12 months after the guidance is published to allow for time to comply with new requirements related to reclassification. They also do not anticipate the change will result in additional inspections of facilities to ensure compliance beyond what is already expected for pre-approval inspection of a product. The agency noted it will give the same leeway regarding new postmarketing safety reporting requirements.
FDA will not have a public comment period before implementation but will consider any comments that are made in determining whether revisions are warranted. Specifically, FDA is looking to hear from stakeholders on whether the 12-month period “is sufficient for affected stakeholders to develop and implement the policies and procedures necessary to comply with the requirements of part 4,” FDA wrote in a listing in the Federal Register.
Some pharmaceutical industry trade groups have opposed FDA’s timeline for implementation of the order. In a comment, the Association for Accessible Medicines (AAM) questioned whether FDA was legally obligated to reclassify these devices at all (RELATED: Pharma, device groups oppose FDA's planned drug to device transition, Regulatory Focus 10 December 2021).
“It was not necessary to reclassify these products under FDA’s authorizing statute or regulations, nor does new case law case demand it. We are concerned that the abrupt decision to do so, without warning and in a way that unduly burdens pending and approved applications, will harm patients,” AAM wrote.
AAM argued that while the Genus decision applied to some standalone products, “the appellate court took pains to emphasize that nothing in the statute – or in the court’s own holding – compels FDA to regulate the individual components of combination products either as ‘drugs’ or as ‘devices’ in their own right.”
“FDA’s reliance on Genus as affirmatively necessitating a specific review or approval pathway for any product with a device component is misplaced,” AAM said.
Federal Register notice, Guidance
