In early October 2015, FDA sent a Warning Letter to Cardiac Designs, Inc. regarding its ECG Check Application and ECG Check Wireless Lead Cardiac Monitor, which is an iPhone-based electrocardiogram monitor.  The company received FDA 510(k) clearance for the mobile app in March 2013.

The Warning Letter came after FDA conducted an inspection of the firm’s facility in Texas.  Specifically, FDA cited the company for failure to “establish and maintain design validation procedures to ensure that devices conform to defined user needs and intended uses and shall include testing of production units under actual or simulated use conditions, as required by 21 CFR 820.30(g).”  FDA maintained that the company did not have records demonstrating the ECG Check Application software was validated.

FDA also asserted that the company failed to establish procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 C.F.R. § 820.198.  FDA noted that while the company used a contractor to receive and initially document all customer communications and complaints, the company’s policies and procedures did not adequately address this practice.  The Warning Letter also maintained that the company’s procedure did not address how it receives, reviews, and verifies complaints that are forwarded from the contract complaint handling company to conduct the complaint investigations.

The Warning Letter further maintained that Cardiac Designs failed to document at least 87 complaints on its Customer Complaint Report Form, as required under company procedure; the complaints were submitted between April 4, 2014 and June 15, 2015.  FDA also stated that it found no records to show that these complaints were reviewed to determine if an investigation was necessary or if they were evaluated to determine if they were reportable events as defined in 21 CFR 803.  This included a complaint indicating a possible failure of the ECG Check Monitor and software to detect an abnormal heart condition.

In addition to these issues, FDA also cited Cardiac Designs for:

  • Failure to establish and maintain procedures for implementing corrective and preventive action, as required by 21 C.F.R. § 820.100(a).
  • Failure to develop, maintain and implement written medical device reporting (MDR) procedures, as required by 21 C.F.R. § 803.17. In particular, FDA noted that the company had no definition of what it considered to be a reportable event under 21 CFR Part 803.
  • Failure to establish a system to ensure all purchased or otherwise received product and services conform to specified requirements, as required by 21 C.F.R. § 820.50.

This Warning Letter is another example of FDA’s focus and attention on medical devices that consist of software and technology that may be used on mobile platforms, such as iPhones or Androids. Stakeholders should review applicable policies and procedures in the early phases of product research and development to address threshold questions, such as whether the product may meet the definition of a medical device.

Manufacturers and developers also should ensure that applicable policies, procedures, and processes are in place to ensure compliance with FDA Quality System (QS) regulations, particularly in the event of an FDA inspection.