federal_register: 97-14751
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| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 97-14751 | Ophthalmic Devices: Reclassification of Rigid Gas Permeable Contact Lens Solution; Soft (Hydrophilic) Contact Lens Solution; and Contact Lens Heat Disinfecting Unit | Rule | The Food and Drug Administration (FDA) is issuing a final rule reclassifying from class III (premarket approval) to class II (special controls) rigid gas permeable contact lens solution, soft (hydrophilic) contact lens solution, and the contact lens heat disinfection unit. Collectively, these devices are referred to as transitional contact lens care products, which include saline solutions; in-eye lubricating/ rewetting drops; disinfecting and conditioning products; contact lens cleaners; and heat disinfecting units. This reclassification is in accordance with provisions in the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976 (the 1976 amendments) and the Safe Medical Devices Act of 1990 (the SMDA). Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance describing the evidence that may demonstrate the substantial equivalence of new contact lens care products to legally marketed predicate lens care products. | 1997-06-06 | 1997 | 6 | https://www.federalregister.gov/documents/1997/06/06/97-14751/ophthalmic-devices-reclassification-of-rigid-gas-permeable-contact-lens-solution-soft-hydrophilic | https://www.govinfo.gov/content/pkg/FR-1997-06-06/pdf/97-14751.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA) is issuing a final rule reclassifying from class III (premarket approval) to class II (special controls) rigid gas permeable contact lens solution, soft (hydrophilic) contact lens solution, and the contact lens... |