A Medical Device Daily

Failure is a big problem, but as a few relatively lucky people know first hand, too much success can create headaches, too. A recent FDA warning letter demonstrated that device firms are still quite capable of growing quickly enough to outstrip their regulatory smarts.

The Jan. 6 warning letter to Hammill Manufacturing (Maumee, Ohio) indicates that FDA's investigators spent more than the usual four or five days at the firm's plant, which makes surgical instruments and implantable orthopedics. The letter states that the inspection spanned the period between Sept. 4 and Nov. 10, 2008. That extra time was apparently well spent, given the laundry list of deviations from the quality systems regulations (QSRs) detailed in the letter.

FDA noted a Dec. 5 response to the inspectional findings, but the fix offered by the company was deemed inadequate in many cases if only because those responses lacked sufficient detail to assure the agency that the corrections would do the trick.

According to the warning letter, more than 15,000 devices shipped from the firm between Sept. 30, 2007 and Oct. 1, 2008, were returned, a failure rate of 7.4%, given the overall volume of almost 210,000. FDA says in the letter that Hammill had not "analyzed and trended this information to identify existing and potential causes" of the non-conformities. A similar citation followed regarding in-process non-conformances involving more than 5,500 devices of unspecified nature.

FDA asked for additional information on a proposed correction for this finding via a revised procedure for corrective and preventive action (CAPA) and a new procedure for data analysis of non-conforming products. The warning letter also separately cites a failure of CAPA procedures to include such data trending, but the agency again asked for clarifying information.

The agency notes in the warning letter that Hammill had failed to include 24 out of 43 in-process non-conformances into a materials data report, adding that "not all low quantity non-conformities (1 to 3) ... are recorded." The company's correction, which is said to have been put into play on Dec. 5, included a procedure "to more thoroughly identify and evaluate the root cause of non-conformances," but again, FDA asked for more data, including data on employee training on the procedure.

Another entry under the CAPA heading was that Hammill "performed several failure investigations and took corrective action outside of your CAPA system for the repeated returns of the polyaxial screws due to coaxial failures." This corrective action was said to have lacked verification and/or validation. FDA saw the firm's response to this finding as inadequate because "it does not assure that this nonconformance and the corrective action taken has been documented" and does not address whether returned products over the year prior to the date of the warning letter had been investigated and corrected.

The warning letter indicates that Hammill's quality control manager "stated that he lacked sufficient time and resources to complete many of the quality system requirements," and the warning letter added that the firm's president, John Hammill, acknowledged that the quality system "has not kept pace with the growth of your firm's business." A proposed addition of a "CAPA coordinator to manage and coordinate all aspects of the CAPA system" was proposed, but lacked background data on the CAPA coordinator, including a curriculum vitae.

Hammill did win the agency's approval for its proposed fix for lack of data on production processes for device master records and for a citation for failure of management to "participate in management reviews," but the warning letter offers no details. At press time, the company had not returned a call for comment.

Guidance on guidances posted

FDA is generally not averse to publishing guidances, but the guidance agenda set by managers at the Center for Devices and Radiological Health for this year is nothing short of ambitious. FDA published a Federal Register notice on Sept. 30 last year listing the guidances it is considering for this year – a guidance on guidances, as it were – and is asking for input on an ongoing basis.

The notice acknowledges that the list "includes topics that currently have no guidance associated with them, topics where updated guidance may be helpful, and topics for which CDRH has already issued Level 1 drafts that may be finalized following review of public comments," but the list is not seen at CDRH as binding or restrictive. CDRH states that part of the reason for the list of potential guidances is that the agency "agreed to meet a variety of goals in return for additional funding from industry" during negotiations over user fees under the Medical Device User Fee and Modernization Act. CDRH hints that it is unlikely that the list will be completed, partly because of unanticipated matters that pop up periodically.

Among the guidances under consideration are those that would address "specific devices" (generally construed to mean specific devices in specific applications), a guidance for assay migration studies for in vitro diagnostics, and a guidance that would address "FDA and industry actions on premarket notification submissions," otherwise known as 510(k)s.

Also on the list are "pacemaker lead adaptor 510(k) submissions" and pacing leads, but a guidance is also possible for hip-joint replacement systems and for heart valves in both IDE and PMA contexts. CDRH is considering a powered wheelchair guidance as well. Among the more exotic treatment types that CDRH may develop guidances for are leeches and maggots.

While the third-party inspection industry is thought to be a niche industry, FDA is giving consideration to a guidance addressing "inspection by accredited persons" as well. Guidances dealing with post-market issues will surely attract a lot of attention, including any that deal with electronic medical device reporting and a guidance that would deal with "precedence on enforcement action determinations."

Those who wish to comment on these or other possible guidances may log on to www.regulations.gov or can snail mail their comments to the address listed on the web page located at http://www.fda.gov/cdrh/mdufma/guidance/agenda/fy09.html.