- CooperSurgical, Inc.
- Issuing Office:
- New England District Office
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
New England District Office
One Montvale Avenue, 4th floor
Stoneham, MA 02180
UNITED PARCEL SERVICE
June 9, 2015
Mr. Paul Remmell
President and Chief Executive Officer
75 Corporate Drive
Trumbull, Connecticut 06611
Dear Mr. Remmell:
During an inspection of your firm located in Trumbull, Connecticut, on November 14 through December 17, 2014, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures, through a contract manufacturer, and markets a product named Infant Heel Warmer. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), this product is a device because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or function of the body.
This inspection and FDA’s review of your firm’s labeling, premarket notification, complaint documents, and other record materials revealed that the Infant Heel Warmer is adulterated and misbranded as set forth below.
First, the Infant Heel Warmer 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 (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g) for the device as described and marketed. Specifically, the Infant Heel Warmer, originally named Instant Warm Gel Pack, was cleared underK912715with an indication to provide heat therapy, but not for use on infants. On June 18, 1990, FDA received the initial 510(k) submission (K912715) for this device, and the cover letter for the submission indicates that the proprietary name of the device is Instant Warm Gel Pack and that the labeling and instructions for use are the same for all three sizes of the device. The labeling in this submission specifically states: “DO NOT APPLY to unattended, confused patients or infants.” Additionally, the predicate device labeling included in the submission advises users to “keep out of reach of children.”
Moreover, your firm’s supplemental information submitted to FDA on September 25, 1991, did not convey that this device was to be used on infants. Specifically, this submission included your agreement to place the following caution statement on the device and on the device box label: “Contents are non-toxic. If contents contact skin or eyes, flush with water. Do not swallow.” You also clarified in the submission that the 304 Heel Warmer reaches a peak temperature of (b)(4) degrees F and the 606 and 709 WarmGel Packs reach a peak temperature of (b)(4) degrees F from a starting temperature of (b)(4) degrees F. The letter identifies the one size being “304 heel warmer.” However, it is unclear based on the name that this device is intended for use on an infant, and no reference to use on an infant can be found in your 510(k) submission.
Despite this regulatory history, your firm has nevertheless renamed the Instant Warm Gel Pack as Infant Heel Warmer and promoted this device for use in providing warmth to increase blood flow and enhance infant blood sample collection. Evidence of this new intended use includes, but is not limited to:
- Labeling of the Infant Heel Warmers as (b)(4) Infant Heel Warmers for (b)(4).
- Quality agreement your firm has with (b)(4) a contract manufacturer, that identifies and includes Infant Heel Warmers.
- Your firm’s memo to file concerning the decision not to submit a 510(k) for the Infant Heel Warmers for infant use.
This evidence demonstrates a major change to the original device’s intended use, for which your firm lacks clearance or approval.
Under 21 CFR 890.5710, hot or cold disposable packs such as the Instant Warm Gel Pack are considered class I (general controls) and therefore exempt from the premarket notification process except when intended for use on infants. Because the subject device is intended for use on infants, the exemption from the premarket notification process under this regulation is inapplicable. Thus, a new premarket notification to FDA for the device is required by section 510(k) of the Act, 21 U.S.C. § 360(k), and 21 CFR 807.81(a)(3)(ii).
Second, the Infant Heel Warmer is misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because your firm introduced or delivered for introduction into interstate commerce the Infant Heal Warmer with major changes or modifications to the device’s original intended use without submitting a new premarket notification to FDA as required by section 510(k) of the Act, 21 U.S.C. § 360(k), and 21 CFR 807.81(a)(3)(ii). For a device requiring premarket approval, the notification required by section 510(k) of the Act, 21 U.S.C. § 360(k), is deemed satisfied when a PMA is pending before the agency as required by 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/ HowtoMarket YourDevice/default.htm. FDA will evaluate the information that your firm submits and decide whether the device may be legally marketed.
We received your response dated January 9, 2015 from James E. Keller, Vice President for Regulatory Affairs and Quality Assurance, which responded to the Form FDA 483, List of Inspectional Observations, issued to your firm on December 17, 2014. Your response is not adequate in that it does not provide any evidence that FDA has reviewed and cleared the Infant Heal Warmer for use on infants.
Third, the Infant Heel Warmer is also misbranded under Section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), because your firm failed or refused to furnish material or information regarding this 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 (MDR) Regulation. Specifically, your firm failed to report to FDA no later than 30 calendar days after the day that your firm received or otherwise became aware of information, from any source, that reasonably suggests that a device that your firm markets has malfunctioned and this device or a similar device that your firm markets would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur, as required by 21 CFR 803.50(a)(2). For example, E-Complaint-(b)(4) includes information that your firm’s device reached a temperature of (b)(4) degrees F, which is a temperature stated by your firm’s Health Hazard Evaluation to be associated with the risk of thermal injury. However, there is no information in your firm’s complaint file to justify why the referenced malfunction would not be likely to cause or contribute to a reportable death or serious injury, if the malfunction were to recur. An MDR for the referenced event has not been received by FDA.
In the January 9, 2015 response, your firm did not provide evidence that an MDR was filed for E-Complaint-(b)(4). Without this documentation, FDA cannot assess the adequacy of your response.
The eMDR Final Rule requiring manufacturers and importers to submit electronic Medical Device Reports (eMDRs) to FDA was published on February 13, 2014. The requirements of this final rule will take effect on August 14, 2015. If your firm is not currently submitting reports electronically, we encourage you to visit the following web link for additional information about the electronic reporting requirements:
If your firm wishes to discuss MDR reportability criteria or to schedule further communications, it may contact the Reportability Review Team by email at ReportabilityReviewTeam@fda.hhs.gov
Your firm should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in regulatory actions being initiated by 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.
Please notify this office in writing within fifteen (15) 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 recurring. Include documentation of the corrections and/or corrective actions (which must address systemic problems) 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 (15) business days, state the reason for the delay and the time within which these activities will be completed.
Refer to the identification number CMS #449979when replying. If you have any questions about the contents of this letter, please contact Diane M. Prince, Compliance Officer (781) 587-7442 or (781) 587-7556 (fax).
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm. It is your firm’s responsibility to ensure compliance with the applicable laws and regulations administered by FDA.
Amber G. Wardwell
Acting District Director
New England District
Close Out Letter