There are ophthalmic digital imaging and PACS systems illegally and openly sold in the US, as well as offered at major industry trade shows, and you will never know it…unless you ask.<\/p>\n
When buying any diagnostic instrument, have you ever thought for a moment whether this device is FDA cleared?\u00a0 Probably not.
\nThere is a well established assumption that every medical device we buy in a clinical setting is legally available for sale and has been cleared or approved by the US Food and Drug Administration.
\nSurprisingly, this is not the case.<\/p>\n
And when you inquire with a vendor about whether they have FDA clearance, the only acceptable response is yes. There are no in-between status levels or stages of progress towards 510(k) clearances. Nor are there experimental or research exemptions for these commonly marketed products and by definition, are not new technologies. And the device classification is Class II, not Class I, as some will try to say.<\/p>\n
PACS and ophthalmic digital imaging systems, including imaging software alone, may only be offered for sale when clearance is\u00a0completed and acknowledged in\u00a0<\/em>writing<\/i>\u00a0by FDA. And FDA mandates a vendor produce proof of 510(k) clearance upon request of relevant parties.<\/p>\n Why is FDA clearance important for medical providers and device manufacturers to recognize?<\/p>\n FDA clearance is the critical milestone in evaluating the safety and effectiveness of all medical devices in order to protect public health.\u00a0 In the case of diagnostic devices we use to treat patients in eye care, the 510(k) process is the defining standard demonstrating safety and effectiveness to FDA prior to offering these devices for sale.<\/p>\n FDA clearance for ophthalmic imaging and PACS systems requires meeting certain Consensus Standards such as ISO for optical performance, radiation (light) emissions safety, extensive software verification and validation, written DICOM and JPEG conformance, adherence to Good Manufacturing Practices and\u00a0Quality\u00a0Systems Regulations, strict\u00a0quality\u00a0production\/ The device Class II applies to instruments used for diagnostic and\/or treatment in humans. This classification is determined in large part by the\u00a0intended use, indications for use and evaluation of risk (including light emission hazards).\u00a0\u00a0<\/em>Imaging systems hardware and software, PACS systems, OCT\u2019s, b-scans and slit lamps are examples of Class II medical devices. Stand alone ophthalmic imaging software is also classified as Class II in this context as it is used for diagnosis and treatment.\u00a0 Class II devices are defined by FDA as prescription items.<\/p>\n The following links define device class by product, as established in the Federal Code of Regulations (CFR<\/span>):<\/p>\n Imaging Systems\u00a0(FDA requires these are treated the same as ophthalmic cameras)\u00a021<\/span>\u00a0CFR<\/span>\u00a0886.1120<\/a> As of this writing, we have found no information at the FDA website referencing the following companies as having either registered their firms and\/or medical devices:<\/p>\n Retinaphile\u00a0<\/u>(Instruments for Vision, Syracuse, NY)\u00a0 has placed ophthalmic imaging systems and stand alone imaging software in commercial distribution \u2013 no FDA 510(k) clearance listed.<\/p>\n Imacam<\/u>\u00a0(Carolina Ophthalmics, Atlantic Beach, NC)\u00a0 has placed ophthalmic imaging systems and stand alone imaging software in commercial distribution \u2013 no FDA 510(k) clearance listed.<\/p>\n\n
\nPACS Systems\u00a0(regardless of specialty)\u00a021<\/span>\u00a0CFR<\/span>\u00a0892.2050<\/a><\/p>\n