Data / Federal rules / 2024-19882
Medical Devices; Ophthalmic Devices; Classification of the Hydrophilic Re-Coating Solution
The Food and Drug Administration published this final rule in the Federal Register on September 5, 2024. It took effect on September 5, 2024.
SpecStream is the live web data engine for teams and agents. It reads every rule and proposed rule in the Federal Register each morning, and this page is that reading. Name your industry once and new rules, comment deadlines and effective dates arrive in your sheet, CRM, Slack or agent as they are published.
What the agency says
The Food and Drug Administration (FDA, Agency, or we) is classifying the hydrophilic re-coating solution into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the hydrophilic re-coating solution's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.
Key facts
- Document number
- 2024-19882
- Type
- Final rule
- Action
- Final amendment; final order
- Agency
- Health and Human Services Department; Food and Drug Administration
- Published
- September 5, 2024
- Takes effect
- September 5, 2024
- Dates
- This order is effective September 5, 2024. The classification was applicable on September 24, 2020.
- Docket
- Docket No. FDA-2024-N-3970
- Code of Federal Regulations
- 21 CFR 886
- Topics
- Medical devices; Ophthalmic goods and services
- Pages
- 2
Other documents from the Food and Drug Administration
Everything from the Food and Drug Administration · Rules on medical devices · Rules on ophthalmic goods and services · Published in September 2024
Read from the Federal Register API, last updated 2026-10-23. The document on federalregister.gov is the official record; dates and dockets can change through later corrections. Free to reuse with credit to SpecStream under CC BY 4.0.