Inspections, Compliance, Enforcement, and Criminal Investigations
Cardiac Science Corp. Response Letter
March 1, 2010
Mr. Charles M. Breen
Food and Drug Administration
22201 23rd Drive SE
Bothell, WA 98021-4421
RE: Response to Warning Letter SEA 10-10
Dear Mr. Breen,
I am in receipt of the Warning Letter dated February 5, 2010, sent to my attention following your inspection of our Bothell, WA facility, which occurred September 1, 2009 through October 1, 2009.
As committed to you in our Form FDA 483 Response dated October 16, 2009, we have taken the observations that resulted from your inspection very seriously. Starting with my appointment as CEO on March 30, 2009, Cardiac Science has vigorously and proactively endeavored to identify and address gaps in our quality system. Our actions were well underway at the time of your inspection and have continued since, addressing and transcending the specific citations of the Form FDA 483 and letter:
• We have completed the restructuring of our Quality/Regulatory organization, hiring several individuals with outstanding technical, medical device, and FDA experience and retaining the services of several subject-matter experts to assist in specific areas.
• We have invested in automated systems to enable better enterprise management and decision-making, improving the accessibility of timely quality-related information and boosting our ability to process quality-related data. We are implementing a learning management system, (b)(4) scheduled for deployment in April, 2010 to support our ability to identify and track training requirements for our employees and document training records more effectively. The implementation of the (b)(4) CAPA module is scheduled to go-live late March, 2016, followed by the (b)(4) Complaint module with a planned implementation date of (b)(4).
• We have designed and commenced implementation of a significant update to our AED self-test, enhancing our ability to seek and detect additional potential component issues. As of the date of this letter, we have started to make this software update (delivered 3 months in advance or our original commitment) available to our base of distributed devices.
• We have undertaken a voluntary field corrective action for over 12,000 devices, removing those devices from service in advance of any reported field event. This action demonstrates our commitment to public health, making timely, risk-based decisions that leverage our enhanced ability to monitor quality data sources.
• In an effort to raise our organization's collective understanding of FDA regulatory requirements, we are in the process of training all employees on relevant portions of the AAMI FDA Quality Systems Requirements and Industry Practice Course. For employees involved in the design and manufacturing of our products (technician level and above) and all executive management, this will be a 40-hour course with practical exam; for other employees, it will be some portion thereof.
• We have initiated the establishment of a corporate-wide product lifecycle approach to risk management. We have completed a gap assessment for our Risk Management System and based on those findings are working to implement risk oriented process improvements throughout our quality system.
During our meeting with the FDA on February 19, 2010 in Silver Spring, MD, we emphasized our strong commitment to work collaboratively with the Agency. We outlined the reasons why we unequivocally believe the enhanced self-test is the best available corrective action for the resistor component issue and any remaining concerns you have about the (b)(4) relay. This software dramatically reduces the risk of any failure to deliver therapy (to one in (b)(4) per year), while keeping AEDs in service where they can protect public health. It is best choice for minimizing occurrence and is commensurate with the projected risk.
For our response to the Warning Letter, we have listed each letter citation in italics followed by a discussion and description of the actions taken (or to be taken) to address your concern and prevent its recurrence. The objective evidence supporting our response is included within the same tabbed section as a numbered attachment(s) identified by the citation number in the letter. In addition, we have provided a tabular executive summary, "FDA Warning Letter Response Summary," which provides an overview of our responses and actions. We respectfully request that this entire response (all three elements - this letter, the executive summary, and our specific response to each cite) be posted on the FDA website alongside the Warning Letter.
The citations in the Warning Letter are receiving serious attention and I am personally committed to their resolution. As well, as shown by our many actions since my appointment as CEO, we are committed to the continuous improvement of the CSC Quality System. We will continue to provide the Seattle District with monthly status updates consistent with the commitments we made in our Form FDA 483 Response, including objective evidence as items are completed.
I appreciated the inclusion of our October 16, 2009 Form FDA 483 Response as part of your letter. However, I noted that the follow-on monthly status updates, sent to the Seattle District Office updating you on our progress to our committed actions for the months of November, December and January, were not considered in your letter. The Warning Letter faulted us on several points for failure to take "any" action, which was an inaccurate reflection of our strong commitment and significant progress since your inspection. As you will note in the attached Warning Letter response, we have indeed undertaken and even completed many actions, and that progress had been communicated to the Agency prior to the issuance of the Warning Letter.
In light of the above, and the undeserved negative characterization of our efforts in the Warning Letter, some of our customers have lost confidence in their Cardiac Science AEDs and more importantly, in the field correction we have begun to implement. It is important for public health to have as many AEDs deployed as possible to protect against sudden cardiac death. For this reason, I respectfully request, in consideration of the additional materials we have provided and your additional review thereof, the FDA revise its Safety Alert as posted on FDA.gov on November 19, 2009 to reflect that our field correction is indeed adequate.
Please contact me directly at (425) 402-2438 if you would like to discuss this matter.
President and Chief Executive Officer
Cardiac Science Corporation