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- Public Inspection
The Food and Drug Administration (FDA or Agency) is proposing to classify the scleral plug into class II (special controls), and proposing to exempt the scleral plugs composed of surgical grade stainless steel (with or without coating in gold, silver, or titanium) from premarket notification (510(k)) and to continue to require premarket...
In this document, the Federal Trade Commission (the ``Commission'') issues a Final Rule implementing the Fairness to Contact Lens Consumers Act (the ``Act''), 15 U.S.C. 7601 et seq., which provides for the availability of contact lens prescriptions to patients and the verification of contact lens prescriptions by prescribers. This document also...
In this document, the Federal Trade Commission (the ``Commission'' or ``FTC'') issues a Notice of Proposed Rulemaking seeking comment on its proposed rule to implement the Fairness to Contact Lens Consumers Act (``the Act''), which provides for the availability of contact lens prescriptions to patients and the verification of contact lens...
The Federal Trade Commission (``FTC'' or ``Commission'') has completed its regulatory review of the Ophthalmic Practice Rules (``Rules''), which require, among other things, that eye care practitioners provide patients with a copy of their eyeglass prescription upon completion of an eye examination. Pursuant to this review, the Commission has...
The Food and Drug Administration (FDA) is amending the monograph for over-the-counter (OTC) ophthalmic drug products (the regulation that establishes conditions under which these drug products are generally recognized as safe and effective and not misbranded). The amendment adds a new warning and revises an existing warning for ophthalmic...
Medical Devices; Reclassification and Codification of Neodymium:Yttrium:Aluminum:Garnet (Nd:YAG) Laser for Peripheral Iridotomy
The Food and Drug Administration (FDA) is announcing that it has issued an order in the form of a letter to Intelligent Surgical Lasers, Inc. (ISL), (now doing business as Escalon Medical Corporation), reclassifying the Neodymium:Yttrium:Aluminum:Garnet (Nd:YAG) Laser for use in peripheral iridotomy from class III to class II (special controls)....