Medical Device Daily Washington Editor

The cost of doing business in the medical device space may have collapsed another device manufacturer if the July 20 warning letter to Arriol International (Santo Domingo, Dominican Republic) is any indication. The maker of osseous injection systems hosted an FDA field investigator for only four days – a substantially shorter length of time than is required for many inspections – and responded to the April 9-12 inspection with an April 27 response, but the telephone number listed for the firm registers as no longer in use, and an e-mail to the firm's customer service department bounced back as undeliverable.

This was the second warning letter in recent weeks dealing with a firm that either closed its doors or at least appears to have done so, the first being Generic Medical Devices (Gig Harbor, Washington), which found its business model badly damaged by its selection of urinary tract slings as one of its first offerings (Medical Device Daily, Sept. 13, 2012). GMD informed FDA in July it would shutter operations.

Arriol was cited for failure to track data from non-conforming products for longer than a month, and FDA alleged that the company had not investigated a redacted number of non-conformances in 2012. One of the problems with the company's response was that it was not in English, but the warning letter also indicated that documentation of corrective action had not been included.

FDA alleged the company had run a validation protocol for sterilization dated April 21, 2010, but the batch was not tested by a contract testing facility until May 5 that year. The firm's response was apparently that the May 5 test had demonstrated bioburden was at allowable levels until after the quarantine period had passed, and promised to run tests to establish 20-day data for hold times. FDA noted that Arriol did not document completion of this effort nor did it provide evidence of systemic corrective actions that addressed “other validation processes.“ FDA informed the company that its products could be refused entry to the U.S.

FDA: Epimed selling without clearance

Contract manufacturing can ease operating costs, but the Sep. 19 warning letter to Epimed International (Irving, Texas) is yet another reminder of the hazards, but perhaps more problematic was the allegation that the company was marketing radio-frequency thermocouple electrodes without a working 510(k). The warning letter says that Epimed had filed a 510(k) for one of its RF thermocouple electrodes with nitinol probes August 26, 2010, but that the application was deemed not substantially equivalent Sept. 1, 2011, slightly more than a year later. The company apparently refilled this past June 6, but FDA states that application had not been processed as of the date of the warning letter.

A two-part citation dealing with procedures dealing with acceptance of incoming product states first that Epimed had been conducting acceptance activities on the RF thermocouple probes “without knowledge of the device's original manufacturing specifications“ as would be provided by the initial manufacturer, or how changes made by that manufacturer, “including sterilization cycles, will affect the device.“

Also under acceptance activities, FDA said that Epimed failed to follow its own procedures requiring that incoming product be tested for Ohms, and also “accepted lots of devices that failed testing.“ In both cases, the warning letter states that the adequacy of the company's response could not be determined, due at least in part to “lack of evidence of implementation“ of corrections.

FDA alleged that the “original supplier/developer“ of RF probes “is not routinely contacted“ to address complaints, and that documents did not support Epimed's claim that complaints were subjected to an “extensive investigation“ to determine a root cause. Here again, the firm's June 7 response to the inspectional findings was deemed inadequate due to lack of documentation of corrective actions.

Perhaps suggestive of the origin of some of these difficulties is a citation stating that Epimed had no agreement with its supplier defining “responsibility for device attributes and quality requirements.“ Further complicating matters here was that Epimed is also said to have failed to require a change notification contract with the supplier of an unidentified product.

The warning letter asserted that Epimed had no specific design validation requirements for RF cannula addressing conformance of finished devices to a defined set of user needs and intended uses, but FDA also said its investigator found no information to identify the lots that had been used for validation activities or “evidence supporting the conclusions based on the test methods used.“

Epimed did not respond to contacts for comment.

Senate staffer: CR allows FY 2012 user fees

Trying to figure out how the continuing federal budget resolution will affect device user fees is no mean trick, and the same can be said for the effects of budget sequestration. However, Jessica Frederick, a Senate Appropriations Committee staffer, told Medical Device Daily that the CR question is pretty clear. FDA “can only collect the same amount they could last year for the first six months of the year.“

Frederick said Congress could have included an anomaly in the CR to allow the new user fee schedule to go into effect, but “we did not include that anomaly.“ She explained that the Office of Management and Budget had asked for an anomaly for FDA user fee programs, but the House was under instructions to limit its use of anomalies. “They thought it wasn't going to hurt the program that much if they didn't include the anomaly,“ she explained, thus it “didn't meet the high bar that was set for the anomaly.“

As for sequestration, Frederick pointed out that the FDA budget “is not exempted, so I think they'll take the same cut as everyone else. The user fee programs are not exempted either.“

The concerns are not identical across centers, however, Frederick explained. “I think PDUFA [the drug user fee agreement] would be fine, but the others would be a lot closer,“ she said. “There is a real concern“ about how the cuts under budget sequestration interact with the triggers found in the various user fee programs, she remarked.

Mark McCarty, 703-268-5690