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Ophthalmic devices comprise products that are in direct or indirect contact with the eye. Typical devices would be contact lenses, intraocular lenses, relevant containers, instruments and implants used to treat the eye. Products may be of metal or polymer origin or fluid in nature (see viscoelastic device), or may be designed for drug delivery.
The following information applies primarily to contact lenses (CL) and intraocular lenses (IOL). NAMSA Technical Specialists and Scientists are adept at developing pre-clinical testing programs for these devices and other ocular products based on international requirements. Department personnel are experienced in contact lens maintenance and lens wear procedures. Ophthalmic surgeons on staff are available to perform intraocular implanting.
Standards and Regulation
The manufacturer should review relevant FDA and ISO guidance documents. In general, the available guidance and/or standards address the suggested test categories found in ISO 10993-1.
Each material should be examined on it's own merits. In some cases, prior data may be available from suppliers or in the literature, or there may be efficacy or functionality testing in progress that can be used to satisfy safety requirements. In some cases, suppliers of lens materials have established FDA Device Master Files (MAF) that can be a source of data.
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