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.

When buying any diagnostic instrument, have you ever thought for a moment whether this device is FDA cleared?  Probably not.
There 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.
Surprisingly, this is not the case.

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.

PACS and ophthalmic digital imaging systems, including imaging software alone, may only be offered for sale when clearance is completed and acknowledged in writing by FDA. And FDA mandates a vendor produce proof of 510(k) clearance upon request of relevant parties.

Why is FDA clearance important for medical providers and device manufacturers to recognize?

  • The FDA clearance process represents the signature commitment by manufacturers to meet certain written quality standards in design, production, manufacturing and post market monitoring
  • If a vendor claims DICOM Conformance, they are required to produce an official DICOM Conformance Statement (attached) –
  • Fundus Reading Centers require FDA clearance for imaging systems and PACS systems in order to be utilized in Clinical Studies
  • CMS requires FDA clearance for all medical devices being used to bill for reimbursement (attached) – CMS Policy Manual
  • It is illegal to sell medical devices that are not cleared by FDA

FDA clearance is the critical milestone in evaluating the safety and effectiveness of all medical devices in order to protect public health.  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.

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 Quality Systems Regulations, strict quality production/process standards and electrical safety standards; just to name a few.

The device Class II applies to instruments used for diagnostic and/or treatment in humans. This classification is determined in large part by the intended use, indications for use and evaluation of risk (including light emission hazards).  Imaging systems hardware and software, PACS systems, OCT’s, 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.  Class II devices are defined by FDA as prescription items.

The following links define device class by product, as established in the Federal Code of Regulations (CFR):

Imaging Systems (FDA requires these are treated the same as ophthalmic cameras) 21 CFR 886.1120
PACS Systems (regardless of specialty) 21 CFR 892.2050

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:

Retinaphile (Instruments for Vision, Syracuse, NY)  has placed ophthalmic imaging systems and stand alone imaging software in commercial distribution – no FDA 510(k) clearance listed.

Imacam (Carolina Ophthalmics, Atlantic Beach, NC)  has placed ophthalmic imaging systems and stand alone imaging software in commercial distribution – no FDA 510(k) clearance listed.

At the FDA public website, ,you may access this public database for medical device registrations and company listings for any and all legitimate medical device companies.

Regardless of which medical device manufacturer you work with…Fundus Photo, Zeiss, Topcon, Merge, Escalon, Kowa, Canon and more, we all have made the quality commitment and financial investment to obtain FDA clearance for these regulated products we offer.

We appreciate your informing relevant parties as to the significance of these illegally marketed products that may be subjected to your patients, physicians, staff, Reading Centers and Clinical Study sponsors.