Medical Device Daily Washington Editor

WASHINGTON – The arrival of new leadership at FDA was widely seen as an augur of a new era at the agency and recent developments have done little to dissuade observers of that perception. The agency's deputy commissioner, Joshua Sharfstein, MD, addressed the crowd at AdvaMed 2009 during a noontime session, and reinforced that idea further, telling attendees that FDA is "very committed to public health." However, he also went out of his way to make the case that "it is very important that FDA not be using old standards for new technology."

Sharfstein discussed the notion of "both incremental and transformative opportunities" that lay in front of the agency and industry, but acknowledged that he is more interested the incremental variety. He said he was especially appreciative of devices made specifically for children. Despite those efforts, "there is a huge gap" in this area, so he said he sees "so much more to be done" to redesign existing devices for pediatric populations.

However, the bulk of Sharfstein's talk addressed the stewardship of the Center for Devices and Radiological Health by the interim CDRH chief, Jeffrey Shuren, MD, who Sharfstein said has "a very clear mandate to move forward on clear priorities."

Among those is an examination and probably substantive changes to the 510(k) program, which Sharfstein said "could be improved," adding that such improvements could be imposed by regulations, administration or by a change in law, a position echoed by the chief of the 510(k) program, Heather Rosecrans (Medical Device Daily, Oct. 15, 2009). Sharfstein noted that one of the prevailing views among the agency's senior managers of the 510(k) program is that some of the relevant standards "are poorly defined," although he offered no details.

Sharfstein said Shuren is assembling an internal group to assess how the process could be "improved," and noted that Shuren is also looking at some "long-term strategic priorities. At the end of it all, Sharfstein said, industry and the public will have "a credible FDA."

Firm's ISO accreditation flunks GMPs

FDA and Health Canada may have a mutual inspection regime in the works, but an ISO certification does not guarantee that a Canadian diagnostics maker will clear an FDA inspection as the Oct. 5 warning letter to Phoenix Bio-Tech (Mississauga, Ontario) makes clear.

The May inspection of the maker of assays used to detect one or more species of the genus Treponoma, led to a citation for lack of documentation for design controls for the firm's Trep-Chek antibody enzyme immunoassay (EIA). Offering no further detail on the citation, FDA states that a document "dated February 2008 is inadequate" because "the procedure fails to adequately describe the process or mechanism for addressing incomplete, ambiguous, or conflicting requirements and does not explain how design inputs are documented, reviewed, and approved as required."

As for the company's response to this inspectional finding on the form 483, the agency states that Phoenix "did not provide a revised copy of the procedures to control the design of" two Treponoma EIAs and "did not provide a copy of your proposed retrospective design analysis and formalized design documentation" for the Trep-Chek. The agency states further that the company did not address "the fundamental deficiency or lack of proper design control processes and procedures which should have been in place before these devices were placed into U.S. interstate commerce."

The company also took a hit for problems associated with validation of design changes to the Trep-Sure assay for Treponoma. The tripwire for this finding, according to FDA, was that a log for the product's label "shows that the labeling for the device had been revised [redacted] times," and that the company could offer no documentation relating to a July 2008 change in validation criteria for a negative control used to validate the assay.

FDA deemed the firm's response to this finding inadequate because a copy of the procedure was "not provided and because evidence of the validation or verification of the design changes was not provided." The agency bootstrapped this into an employee training citation with the remark that Phoenix "did not provided evidence of . . . retraining activities, which should include the validation or, where appropriate, verification of this corrective action and evidence of proposed preventive action."

FDA included a rather vague citation for "failure to validate computer software for its intended use according to an established protocol when computers or automated data processing systems are used as part of production or the quality system." The only other detail for this is a passage stating, "no validation information or protocols were provided for the [redacted] software which is used for product complaints, CAPA requests/actions, preventive action request/actions, and creating quality logs."

The agency offered little detail as to the firm's response to this finding, stating only that the response was "inadequate because a copy of your revised procedures and the Excel spreadsheet validation protocols/procedures and reports were not provided." The warning letter also states that the response was not clear as to "how you plan to document quality system records that were previously documented in the [redacted] system."

Phoenix was also cited for failure to produce a procedure for medical device reports (MDRs) during the inspection, and FDA deemed inadequate a response dated Aug. 1 that included a proposed procedure that FDA said did not contain "a standardized review process for determining when an event meets the criteria for reporting." The agency also reported that the proposed correction omitted provisions "for the timely submission of complete medical device reports and supplements as required." FDA closed the letter by notifying the firm that a failure to make timely corrections could result in detention.

In an unattributed e-mailed statement, Phoenix told Medical Device Daily that the company agreed that "process variations between each quality system have resulted in a lack of compliance with the FDA regulations." The firm goes on to state, "the process and procedures used for design control were found to be in compliance with the Health Canada and ISO 13485 regulations," which the company says was "independently verified by an accreditation agency (Intertek)."

Phoenix said it is "committed to the continual improvement of our quality system through the critical monitoring and measurement of our policies, procedures and products."