WARNING LETTER

Draegar Medical Systems, Inc. MARCS-CMS 596529 — January 17, 2020

Delivery Method:: United Parcel Service
Product:: Medical Devices

Recipient:: Recipient Name

Stefan Dräger; Recipient Title

Chief Executive Officer; Draegar Medical Systems, Inc.; Draegerwerk AG & Co. KGaA
Moislinger Allee 53-55
23542 Luebeck
Germany; Stefan.Drager@draeger.com

Issuing Office:: Office of Medical Device and Radiological Health Operations (Division 1); United States

WARNING LETTER
CMS # 596529

January 17, 2020

Dear Mr. Dräger:

The United States Food and Drug Administration (FDA) conducted an inspection of your firm’s medical device operations, Draeger Medical Systems, Inc., located at 6 Tech Drive, Andover, MA, from August 20 through September 20, 2019. During the inspection, an FDA investigator determined that your firm is a medical device manufacturer of multi-parameter patient monitoring systems, including the IACS M540 (Infinity Acute Care System) and the ICS M300 (Infinity Central Station Wide). Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body.

Our inspection revealed that the IACS M540 (Infinity Acute Care System) device 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). For a device requiring premarket approval, the notification required by section 510(k) is deemed satisfied when a PMA is pending before the agency. [21 CFR 807.81(b)] The kind of information that your firm needs to submit in order to obtain approval or clearance for the device is described on the Internet at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm. The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.

Specifically, Letters to File dated May 1, 2013, January 15, 2014, April 27, 2015 and January 25, 2016, (b)(4). The changes (b)(4), which may affect monitoring and result in patient injury or death. For example, a patient with a life-threatening arrhythmia may not be detected or alerted adequately, resulting in adverse events. These changes represent significant modifications that could significantly affect the safety or effectiveness of the device such that a new 510(k) premarket notification must be submitted. In your firm’s response, dated October 10, 2019 and November 8, 2019, your firm notes that it will address all changes in one or more 510(k) submissions in accordance to discussions with FDA. Your response is not adequate because we have not yet received your 510(k) submission.

This inspection also revealed that the above 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 requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820.

We received your responses dated October 10, 2019, November 8, 2019 and December 13, 2019, from Carsten Kossler, Vice President System Solution Research and Development, and Lida Reed, Director Quality, which responded to the Form FDA 483, List of Inspectional Observations issued to your firm on September 20, 2019. We address your October 10, 2019 and November 8, 2019 responses below and will address your December 13, 2019 response with your response to this letter.

These violations include, but are not limited to, the following:

1. Failure to establish and maintain procedures for validating the device design that includes risk analysis, where appropriate, as required by 21 C.F.R. § 820.30(g). For example:

Your (b)(4) indicates (b)(4). Complaint Number 79518 (dated August 6, 2018) noted that (b)(4) was reviewed to investigate the complaint. (b)(4) pertains to the (b)(4). Your (b)(4) indicates in (b)(4) Product Risk Management Report as defined in your (b)(4). The (b)(4) was approved (b)(4).

We reviewed your firm’s response and conclude that it is not adequate. You indicated you have opened a CAPA to address the deficiency and are in the process of implementing corrective actions.

Your complete analysis of the cause of the non-conformance, correction, broader corrective actions and effectiveness checks are needed in order for us to assess your corrective actions. In response to this Warning Letter, you should provide confirmation that these proposed corrective actions are appropriate and effective. For example, this should include documentation of the updated processes including, but not limited to the (b)(4).

2. Failure to establish and maintain procedures for verifying the device design to confirm that the design output meets the design input requirements, as required by 21 C.F.R. § 820.30(f). For example:

Your (b)(4).

We reviewed your firm’s response and conclude that it is not adequate. You indicated you have opened a CAPA to address the deficiency and are in the process of implementing corrective actions. Your complete analysis of the cause of the non-conformance, correction, broader corrective actions and effectiveness checks are needed in order for us to assess your corrective actions. In response to this Warning Letter, you should provide confirmation that these proposed corrective actions are appropriate and effective. For example, this should include documentation of the updated processes including, but not limited to (b)(4).

3. Failure to establish and maintain procedures for defining and documenting design output in terms that allow an adequate evaluation of conformance to design input requirements, as required by 21 C.F.R. § 820.30(d). For example:

Your (b)(4). However, this (b)(4) the applicable network requirements specified in the (b)(4).

We reviewed your firm’s response and conclude that it is not adequate. You indicated you have opened a CAPA to address the deficiency and are in the process of implementing corrective actions. Your complete analysis of the cause of the non-conformance, correction, broader corrective actions and effectiveness checks are needed in order for us to assess your corrective actions. In response to this Warning Letter, you should provide confirmation that these proposed corrective actions are appropriate and effective. For example, this should include documentation of the updated processes including, but not limited to the (b)(4).

4. Failure to establish and maintain procedures for implementing corrective and preventive action, as required by 21 C.F.R. § 820.100(a). For example:

Your procedure (b)(4). Complaint Number 72810 (dated October 16, 2017) noted cybersecurity vulnerabilities, which affect multiple product lines. Defect or Change Requests related to the identified vulnerabilities documented (b)(4).

We reviewed your firm’s response and conclude that it is not adequate. You indicated you have reviewed complaint data to address the deficiency and are in the process of implementing corrective actions. Your complete analysis of the cause of the non-conformance, correction, broader corrective actions and effectiveness checks are needed in order for us to assess your corrective actions. In response to this Warning Letter, you should provide confirmation that these proposed corrective actions are appropriate and effective. For example, this should include updated documentation including, but not limited to updated CAPA process training, assessment of all potential CAPA input (b)(4).

Your firm should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties. Also, federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this information into account when considering the award of contracts. Additionally, should FDA determine that you have Quality System regulation violations that are reasonably related to premarket approval applications for Class III devices such devices will not be approved until the violations have been corrected. Also, should FDA determine that your devices do not meet the requirements of the Act, requests for Certificates to Foreign Governments (CFG) may not be granted. More information on processes for persons denied a CFG can be found at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/process-request-review-fdas-decision-not-issue-certain-export-certificates-devices. If you believe that your products are not in violation of the Act please respond to FDA with your reasoning and any supporting information for our consideration.

Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to correct the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (which must address systemic problems) that your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firm’s response should be comprehensive and address all violations included in this Warning Letter.

If you have questions regarding any issues in this letter, please contact Compliance Officer, Karen Archdeacon at 781-587-7491 or at karen.archdeacon@fda.hhs.gov. Please send your reply electronically to Gina Brackett, Director of Compliance Branch, at oradevices1firmresponse@fda.hhs.gov.

Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems. Your firm should investigate and determine the causes of the violations, and take prompt actions to correct the violations and bring the products into compliance.

Sincerely,
/S/

Joseph Matrisciano, Jr.
Program Division Director
Office of Medical Device and Radiological Health
Division 1

/S/

Bram D. Zuckerman
Director
Office of Cardiovascular Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Cc: Carsten Kossler, Vice President System Solutions Research & Development, Carsten.Kossler@draeger.com