Confusion over 510(k) filing prompts FDA warning to Medweb

Confusion over 510(k) filing prompts FDA warning to Medweb

Company says filing will extend to new technologies

Web-based image management software developer Medweb of San Francisco is responding to a request from the Food and Drug Administration for additional documentation covering the 510(k) clearance for its Web-based image management products. Medweb executives say the company is in the process of filing an amended 510(k) that will both assuage the FDA's concerns and extend coverage to new technologies recently incorporated into its product line.

The FDA's attention was originally drawn to the company because the 510(k) for its MediPACS product line was issued under Medweb's previous name, Nexsys Electronics, according to Dr. Peter Killcommons, Medweb president. Nexsys changed its name to Medweb in 1996, although it still ships products to OEM customers under the Nexsys name.

The FDA requested clarification on the discrepancy between the name on the 510(k) and the name under which the products covered by the documentation were being sold. Medweb did so, referring the FDA to the 510(k), which was granted in June 1995. In examining the clearance, FDA regulators noticed that the document does not mention the World Wide Web, even though Medweb's products enable users to distribute images over the Web as a plug-in for Netscape's Navigator Web browser. This discrepancy prompted an FDA warning letter, which was sent to Medweb in May.

The letter claims that Medweb has been selling its Radiology Workstation Plug-In for Netscape Navigator without the appropriate FDA clearances, and thus is "misbranded" and "adulterated," according to federal regulations. The letter claims that Medweb's product includes featuresæspecifically Web connectivity, Netscape interface, and wavelet compressionæthat were not included in its original 510(k) submission.

Killcommons said that the 510(k) does support the functions mentioned in the FDA letter, but the company's document does not specifically mention them by name because Medweb didn't want to tip off its competitors.

"We described the Web browser in detail, but we didn't use the words 'World Wide Web' because our competitors would be monitoring stuff like that," Killcommons said. "We didn't say 'wavelet compression,' we said 'lossy compression.'"

Medweb has responded to the FDA's letter, pointing out that such features are indeed covered by the 510(k). To further alleviate the FDA's concerns, however, Medweb agreed with the FDA's request to file an amended 510(k) application to cover the features in question. The FDA has not asked Medweb to stop shipping the product, nor has the agency taken any disciplinary action, according to Killcommons.

Medweb has decided to take advantage of the opportunity offered by the amended 510(k) filing to include new functions it is adding to its browser technology.

"We followed the letter of the law, but to make everyone more happy, we are taking it the next level," Killcommons said.