Medical Device Daily Washington Editor

Device makers doing business in the U.S. sometimes find it difficult to fathom how FDA classifies devices, but those doing business in Europe might get the same feeling.

To address any confusion, EU authorities recently published a brief document giving examples of how "grey-area" devices are classified.

The document, the Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices, says that it serves "only as a tool for the case-by-case application of community legislation in the member states," but adds that varying definitions of devices and in vitro diagnostics "can put public health at risk and distort markets."

In one example, a blood-typing device was promoted for the purpose of determining "whether a specific food diet should be allowed," but is explicitly not for determining a diet appropriate "for medical purposes." Because the disclaimer states that the results "cannot be used for transfusion purposes or for blood group determination for medical purposes," the kit escapes regulation as a device of any kind.

An example of a device that might not seem like a device is a specimen sample collection receptacle for diagnostic work-up. According to the document, such a receptacle – even when ordered by the patient – that is sent in to a diagnostic lab "in some type of storage container" would qualify as an in vitro diagnostic even when no healthcare professional is involved. The receptacle is subject to regulations because they are "intended ... for the preservation and shipment of specimens ... for the purpose of in vitro diagnostic examination."

The document tackled examination gloves, which typically show up as Class I devices in the EU system, but the case changes for a glove coated with polyhexamethylene, a broad-spectrum bactericide.

Devices that incorporate substances that have no "ancillary effect on the patient" would qualify as Class I devices, but the document asserts that because these gloves incorporate "substances as an integral part which, if used separately, may be considered to be a medicinal product," they qualify as Class III devices. The document addresses several other devices, including a light box designed to treat seasonal affect disorder.

Warning letters spend time in queue

Like all entities of any size, some jobs at FDA get caught up in delays, and the publication of warning letters is no exception as two letters from last year finally made it to the agency's web site.

The Sept. 28 warning to Cameron-Miller (Chicago), maker of surgical instruments, noted that the inspection took place a year ago, and cited the firm for failure of management "to establish its policy and objectives for and commitment to quality." FDA said that the firm's June 13 response would be written and implemented, and the agency said it would "evaluate the adequacy of this response during the next inspection."

The agency had the same response to a citation for lack of quality audits and for lack of procedures for device rework.

The warning letter cited Cameron-Miller for inadequate documentation of repair records for electrosurgical instruments, more than one of which were distributed despite the fact that they failed to meet specifications. FDA said the company's response "is inadequate because it does not describe the steps your firm will take to ensure compliance."

At press time, Cameron-Miller had not responded to calls for comment.

The Oct. 2 warning letter addressed to iScreen (Memphis, Tennessee), was in the FDA pipeline for a couple of months as well. The letter stated that iScreen's development of specifications for Class II ophthalmic cameras lacked documentation on several fronts.

FDA said that the company had no documented procedures for corrective and preventive action (CAPA), and "does not document ... activities such as trend analysis of sources of quality data" to address non-conforming product. Due to lack of documentation, the agency was unable to assess the firm's response.

The letter says that iScreen "was aware that the laptop computers and iScreen cameras eventually would have problems communicating with each other and made the decision to only upgrade the software as customers began to experience problems." FDA said the firm's response to this was inadequate because "you did not include a copy of your CAPA report for our review."

The upgraded software was itself the source of a citation due to failure to document the validation of that software. The company's response to this finding was likewise rejected due to lack of supporting documentation.

Device history records were said to have lacked histories for units that are reprocessed and resold, and iScreen also lacked a system for medical device reports.

Jack Bellows, iScreen's president, told Medical Device Daily "we have addressed the issues in the warning letter and are now in compliance."

The March 25 warning letter to Xoran Technologies (Ann Arbor, Michigan) came out a bit more promptly, and addressed the findings from an August 2007 inspection during which the maker of the MiniCAT CT system was cited for a number of violations suggesting unfamiliarity with the quality systems regulations.

The first citation was that Xoran's device history files for the MiniCAT "did not contain test methods, equipment specifications to support equivalency, and supporting test data such as supporting image scans." The second citation does not name MiniCAT documentation specifically, but says only that device master records lacked references to the locations of "all device and software specifications, all production and process specifications, or all installation, maintenance and servicing procedures and methods."

FDA said that Xoran did not validate software "used to calibrate the geometric calibration test and the resolution phantom test ... for the MiniCAT system." The company was also cited for failure of management "to review the suitability and effectiveness of the quality system ... as is evident by the observations listed above."

The warning acknowledged a Dec. 13 letter from the company's manager of regulatory affairs, but "we have concluded that the response is inadequate because there are no specific steps outlined to correct the violations and prevent their recurrence."

The company had not responded to calls for comment by press time.