iRythm Technologies, Inc. was issued a warning letter from the FDA. SoftwareCPR comments: This Warning Letter demonstrates the need for:
- Quality systems to stay compliant (CAPA and complaints!)
- Regulatory oversight to engineering and marketing activities
- Really communicating product behavior in the IFU!!”
Excerpts from a warning letter of interest to software professionals:
“As stated in the Zio AT System indications for use, the system is intended to continuously record and report patient symptomatic and asymptomatic cardiac events and continuous electrocardiogram (ECG) information. After wear, a final report of the entire ECG recording is generated. The ZEUS software system is a component of the Zio AT system and supports the capture, reporting, and analysis of arrhythmia events. The reports are provided to a reviewer to render a diagnosis. Therefore, the reports are components of the device system. Because Zio AT System (“Zio AT”) is intended for use in the diagnosis of disease, the Zio AT system, including its components, is a device within the meaning of section 201(h).”
These violations include, but are not limited to, the following:
- Changes were made to the device without a new 510(k) submission. More specifically, the Zio AT System is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption under section 520(g) of the Act, 21 U.S.C. § 360j(g). The device is also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce the device into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k).
- Quality System Regulation (QSR) violations: This inspection also revealed that these devices are adulterated within the meaning of section 501(h) of the Act, 21 U.S.C. § 351(h), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System regulation found at 21 CFR part 820.
- Medical Device Reporting (MDR) Violations: Our inspection also revealed that your firm’s Zio AT system is misbranded under section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), in that your firm failed or refused to furnish material or information respecting the device that is required by or under section 519 of the Act, 21 U.S.C. § 360i, and 21 CFR Part 803 – Medical Device Reporting.
For more information, see the link below:
