Medical Device Daily Washington Editor
An Oct. 14 letter to Congress from officials at the Center for Devices and Radiological Health at FDA to Rep. John Dingell (D-Michigan), has stirred up a hornet's nest of controversy that hints at a shake-up at CDRH, but also suggests that the current approach to clearance of 510(k) devices is on shaky ground.
The Government Accountability Office is scheduled to release a report on the process at any time, and any bad news in that report may end up making device clearance a much more cumbersome process in the years to come.
The Oct. 14 letter, the names of whose authors were redacted, alleges "serious misconduct" on the part of senior management at CDRH, including charges that "managers at CDRH have corrupted and interfered with the scientific review process of medical devices."
Prior to the letter to Dingell, who last week was displaced as chairman of the House Energy and Commerce Committee, the matter was taken up by William McConagha, the agency's director for integrity and accountability, but the authors of the letter argue that the investigation has yielded little action and that "the director of CDRH [Daniel Schultz] has further aggravated the situation by knowingly allowing a continuation of management reprisals." However, the letter fails to make specific accusations on these charges.
The authors call for "new legislation that modernizes the regulatory structure of the 510(k) program so that complex medical devices are not allowed on the market without a comprehensive ... clinical evaluation of their safety and effectiveness." The authors of the letter state that "there has been enormous internal resistance from the entrenched managers at CDRH, including the center director and the director of ODE," a reference to Donna Bea Tillman, PhD, director of the Office of Device Evaluation.
Former FDA commissioner Bill Hubbard, now with the Alliance for a Stronger FDA (Washington), told Medical Device Daily that "its not unusual for employees to complain, but it is unusual" for employees to send a letter to Congress. "Part of the problem with reviewers is that some tend to overreact to management decisions," Hubbard observed, but noted that in some instance, "they were quite right" in reference to unspecified drug approval decisions.
Complaint, CAPA hits dot warnings
The number of warning letters addressing corrective and preventive action (CAPA) and complaint procedures seems to never fade very much, and a Nov. 3 warning letter to Spacelabs Healthcare (Issaquah, Washington) is a recent instance.
Spacelabs, which makes a variety of patient monitoring and telemetry devices, was under the FDA magnifying glass in April and May, but despite four letters from the company between June and September, the firm landed a warning letter with five citations for complaint handling and CAPA, as well as another two dealing with medical device reports (MDRs).
FDA states in the letter that the company's complaint files includes a number of files that were not closed out within the 90 days required by Spacelabs' standard operating procedures (SOPs). According to FDA, more than one complaint was open for more than 500 days.
The company's response to this finding was deemed inadequate because the revised procedures were apparently not yet in place despite training exercises in the new SOPs.
Another citation states that technical support manager had not reviewed 12 complaints that product support specialists had disqualified, listing this finding under a CAPA heading. According to FDA, the company had implemented the SOP requiring the review by technical support managers in December 2007.
Again, the firm's responses were deemed inadequate, but FDA offers no specific explanation, asking only that Spacelabs forward a summary of the firm's review of these records as well as an explanation "of the corrective and preventive actions ... that you will implement to address this deviation."
Among the MDR reports the firm is said to have failed to file was one in which a patient suffered a "hypoxic episode resulting in subsequent heart failure and brain damage." According to FDA, Spacelabs was conducting a review of incidents dating back to 2005 to establish whether any other reports should be filed, but the company had not updated the agency as of the date of the warning.
Roy Hayes, Spacelabs' VP-quality control and regulatory affairs, told MDD that the company's response "should go to them today or tomorrow" and that the company "came up with a pretty extensive plan to make improvements.
"At this point, we feel confident that the things we've done answer their questions," Hayes said. He also noted that "we went to the outside [for help on updating compliance efforts] and that's been very helpful," adding "I think everyone agrees we're a better company for it."
Hayes said the firm has been inspected "every two years or so, but none of the previous inspections" found problems. He said that his impression is that where GMP and quality systems compliance standards are concerned, "the benchmark has changed over time," stating further, "this past inspection was different from previous ones."
A Nov. 4 warning letter to Innovative Neurotronics (Austin, Texas), maker of devices designed to augment the nerve system in limbs, commenced with a citation addressing the company's use of a contract manufacturer.
FDA cited Innovative for failure to evaluate the third party "for its ability to meet your quality requirements despite the fact that your firm experienced quality issues which resulted in many complaints and two product removals."
The company's response to this finding fell short because it indicated that Innovative "has been evaluating the contract manufacturer the past two years," but that process "has not been formalized."
FDA cited the firm's CAPA procedures for failure to include documentation of a rework of an unspecified device in which "inverted stimulation output" caused "interference with the components on a printed circuit board." The agency stated that Innovative "has not verified and documented that the rework actually corrected the interference," and had not effected a design change to eliminate the problem.
The agency states that the rework, which took place in February 2007, did not head off a similar problem that arose this past June, noting that Innovative had not established the exact nature of the "defects found in your contract manufacturer's production lines." This was also the source of a citation for failure to validate a change to the design of the unnamed product.
In an unattributed statement, the firm indicates that it is "working closely with the FDA to address the issues raised in the warning letter" and that Innovative has "implemented a vendor quality improvement plan to enhance our overall quality system."