At the WVC this year there was much talk about FDA approval by the digital radiography vendors. The implication by several vendors is that FDA approval means you are purchasing a better quality digital radiography system.

Is this true? Should you care if your veterinary CR, DR, or PACS is FDA approved?

Background on the FDA regulation of medical devices.

{joso}On the human side (the FDA is currently only concerned with devices marketed for human use) before a medical device can be marketed in the USA a marketing application must be submitted and cleared by the FDA.

Digital radiographic equipment is subject to a 510(k) pre-market approval. The 510(k) demonstrates that the device to be marketed is at least as safe and effective or substantially equivalent, to a similarly, legally, marketed device. The legally marketed device(s) to which equivalence is drawn is commonly known as the "predicate."

A second segment of the FDA approval is the Good Manufacturing Practice (GMP) requirement set forth in the Quality System (QS). These regulations require that the manufacturer has a quality system for the design, manufacture, packaging, labeling, storage, installation, and servicing of finished medical devices intended for commercial distribution in the United States. The regulation requires that various specifications and controls be established for devices; that devices be designed under a quality system to meet these specifications; that devices be manufactured under a quality system; that finished devices meet these specifications; that devices be correctly installed, checked and serviced; that quality data be analyzed to identify and correct quality problems; and that complaints be processed. Thus, the QS regulation helps assure that medical devices are safe and effective for their intended use. The Food and Drug Administration (FDA) monitors device problem data and inspects the operations and records of device developers and manufacturers to determine compliance with the GMP requirements in the QS regulation.

In short,the FDA looks at whether the product is as safe as the ones that came before it and whether there is a quality control program in place during manufacturing. The FDA also has the ability to audit manufacturers to determine compliance with the QS regulation.

Look at what the FDA does not regulate

The FDA does not get involved with image quality, usability, features, DICOM connectivity, or features needed for the day to day functioning of the system.

As it was imparted to me “the problem is that any one can register as a manufacturer, have a poor or no quality system, hope (and reasonably expect) never to be audited, claim equivalence and market a device that has no real safety-related issues but is still unreliable and difficult to use. For example, one could sell a "workstation" that had no DICOM connectivity, no ability to window or zoom images, and displayed horrible quality on a cheap monitor, but claim substantial equivalence to something already on the market and likely get a 510(k). One might even have an outstanding ISO quality manufacturing process in place to build it, and pass a compliance audit with flying colors. Yet the device would be useless to the user”

“Big vendors get audited more often, and often have better quality processes in manufacturing, yet still deliver systems that fail or don't satisfy the customers' expectations (with the exception of clear safety hazards). Many small vendors might fail a compliance audit, but still produce an excellent device. Each vendor prioritizes the allocation of resources to innovation, testing, quality and regulatory compliance differently. Also, documentation of quality is not the same thing as actually achieving it.³”

The Bottom Line: Do not be fooled by digital radiography vendors who mislead you into thinking that FDA approval is a guarantee that you are buying a superior digital radiography product. All veterinarians should evaluate a digital radiography system based on image quality, features, service record, cost and other items that are important to the day to day use of the product. If the system you are looking at satisfies those requirements, FDA approval is an added benefit.

References:

1. http://www.601help.com/Regulatory/fda.html
2. http://www.fda.gov/
3. David Clunie – communication