Last Updated on April 11, 2022 by The Health Master
Indian ophthalmic players see importance of USFDA norms for eye dropper bottles administering the drug directly into the eyes stall impurities.
The guidance titled as Certain Ophthalmic Products: Policy Regarding Compliance With 21 CFR Part 4 is for immediate implementation indicated the global regulator.
This guidance is intended to provide information to applicants and manufacturers regarding compliance with the requirements 21 CFR part 4 for ophthalmic drugs packaged with eye cups, eye droppers, or other dispensers.
It applies to products with pending applications and approved products. USFDA is implementing this guidance without prior public comment because the Agency has determined that prior public participation is not feasible or appropriate.
Regulating ophthalmic dispensers as drugs is a departure from how USFDA regulates other devices that are packaged with the drugs with which they are intended to be used.
Specifically, when a device is packaged together with the drug with which it is intended to be used, USFDA regulates that drug and the device together as a combination product.
Ophthalmic dispensers are regulated as drugs. Therefore, USFDA 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 or an ophthalmic dispenser.
Applicants and manufacturers are not expected to retroactively prepare certain parts of the development plan or conduct design review meetings for the product as currently marketed because the development stages that these activities would support have already occurred.
However, they should put a design and development plan in place, and they should have procedures for design review meetings in place to support future design activities such as future design changes, said the global regulatory authority.
Additionally, some ophthalmic products that were not previously regulated as combination products incorporate lower-risk device constituent parts, for example, eye dropper bottles/ampules that administer the drug directly to the eye.
The Agency is evaluating the application of part 820 quality system (QS) requirements to combination products that include such constituent parts.
Generally, USFDA intends to request the ophthalmic manufacturers to provide an updated Form USFDA 356h to the pending application, indicating that the product is a combination product and identifying all facilities involved in the manufacturing of the combination product.
This will include all facilities involved in the manufacturing of each constituent part and all facilities responsible for the disposition of the combination product.
The global regulator may determine that, based on the risk profile of the combination product, information to demonstrate compliance with any applicable device quality systems regulation requirements is most appropriately assessed during inspection following approval.
In such cases, this information should not be submitted in the application but must be available upon inspection to demonstrate your compliance with part.
India has large base of ophthalmic manufacturers including Allergan, Sun Pharma, Micro Labs, Dr Reddy, Wellona Pharma, Neiss Labs, Hanuchem Laboratories, Endtod Pharma. These companies see that the importance of the USFDA norms and the criticality of droppers which could lead to eye injuries.
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