federal_register: 96-7784
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| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 96-7784 | Medical Devices; Reclassification and Codification of Rigid Gas Permeable Contact Lens Solution; Soft (Hydrophilic) Contact Lens Solution; and Contact Lens Heat Disinfecting Unit | Proposed Rule | The Food and Drug Administration (FDA) is proposing to reclassify 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 response to 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). FDA is also amending the regulations for transitional contact lens care products to more accurately reflect the intent of the original regulation. Under the SMDA, FDA is implementing a special control that the agency has determined is necessary to provide reasonable assurance of the safety and effectiveness of the proposed reclassified contact lens care products. That special control is the availability of guidance for premarket notification submissions for these products. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a draft guidance describing the evidence that demonstrates the substantial equivalence of new contact lens care products to contact lens care products already marketed. | 1996-04-01 | 1996 | 4 | https://www.federalregister.gov/documents/1996/04/01/96-7784/medical-devices-reclassification-and-codification-of-rigid-gas-permeable-contact-lens-solution-soft | https://www.govinfo.gov/content/pkg/FR-1996-04-01/pdf/96-7784.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA) is proposing to reclassify 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... |