Inspections, Compliance, Enforcement, and Criminal Investigations
Nuvolase Inc. 5/8/14
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|San Francisco District|
1431 Harbor Bay Parkway
Alameda, CA 94501-7070
Telephone (510) 337-6700
VIA UNITED PARCEL SERVICE
Return Receipt Requested
May 8, 2014
Steven P. Duddy
President and Chief Executive Officer
520 S. El Camino Real, Suite 210
San Mateo, CA 94402
Dear Mr. Duddy:
During an inspection of your firm located at 11 Ilahee Lane, Chico, CA on August 28 through September 20, 2013, an investigator (or investigators) from the United States Food and Drug Administration (FDA) determined that your firm manufactures the PinPointe Touch Screen Laser and the PinPointe Foot Laser. 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 is intended to affect the structure or any function of the body.
Our inspection revealed that your firm’s PinPointe Touch Screen Laser and PinPointe Foot Laser devices are 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). The devices are also misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), because you introduced or delivered into interstate commerce for commercial distribution a device with major changes/modifications to the intended use without submitting new premarket notification to the agency as required by section 510(k), 21 U.S.C. § 360(k), and 21 CFR 807.81(a)(3)(ii).
Specifically, the PinPointe Touch Screen Laser and PinPointe Foot Laser devices were cleared under K130413 and K093547, respectively, with the following indication:
- The PinPointe Foot Laser is indicated for use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.).
However, information obtained during the inspection and FDA’s review of your firm’s websitefor the PinPointe Touch Screen Laser and PinPointe Foot Laser devices provides evidence that the devices are intended for the following indications:
- treatment of onychomycosis
- destruction of fungus and other organisms in and under the nail plate
- being effective in addressing nail infections
These indications would constitute a major change or modification to the devices’ intended use, for which you lack clearance or approval. For example, the device labeling collected during our inspection found the following claims for the devices:
PinPointe Footlaser Operator’s Manual
- “Podiatry: Treatment of Chronic Fungal Toenail Infection (Onychomycosis)”
PinPointe FootLaser Clinical Reference Manual
- Treatment Indications: “A specific indication for use is the treatment of onychomycosis.”
- Treatment with the Footlaser: “When using the PinPointe Footlaser for the treatment of onychomycosis, the following protocol is recommended:”
- PinPointe Footlaser Consent Form: “The Nd:YAG FootLaser energy penetrates the nail and destroys the fungus and other organisms in and under the nail plate.”
In addition, FDA’s review of your firm’s website at www.nuvolase.com (last visited on May 7, 2014) includes the following claims:
- “Current Procedures for Infected Nails…Laser procedure: in-office procedure”
- Under “Benefits” for PinPointe Footlaser: “Effective in addressing nail infections...”
Your devices’ cleared indications for use are for the “temporary increase of clear nail in patients with onychomycosis,” which only addresses the appearance of the nail. Promotion of the PinPointe Touch Screen Laser and PinPointe Foot Laser devices for the treatment of onychomycosis is a major change or modification of the device’s intended use.
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. 21 CFR 807.81(b). The kind of information 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 your firm submits and decides whether the products may be legally marketed.
Our inspection also revealed that your devices are adulterated within the meaning of Section 501(h) of the Act, 21 U.S.C. § 351(h), because 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 (CGMP) requirements of the Quality System (QS) regulation found at 21 CFR part 820. These violations include, but are not limited to, the following:
1. Failure to establish and maintain procedures for implementing corrective and preventive actions (CAPAs) including the requirement to analyze all quality data to identify existing and potential causes of nonconforming product as required by 21 CFR 820.100(a)(1). Specifically, in April 2013, your regulatory consultant notified you that your promotion and labeling for the PinPointe lasers may exceed the cleared indications for use, but you failed to analyze this data to determine if an investigation and/or corrective actions were necessary
2. Failure to confirm that the design output meets the design input requirements and ensure the results of the design verification, including identification of the design, methods, date, and individual performing the verification are documented in the design history file as required by 21 CFR 820.30(f). Specifically, the indications for use in the device labeling failed to meet the cleared indications for use, a design input as designated by Nuvolase. In addition, our investigator asked several times during the inspection for documentation that the design output (labeling) had been verified to meet the design input. Our investigator was told that there was no documentation.
We have reviewed your firm’s response, dated October 10, 2013, and determined that your corrective actions cannot be adequately evaluated as the documentation of the corrective actions, such as plans to revise the labeling and promotional materials, implement CAPA, and initiate design verification, was not submitted in your response.
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, premarket approval applications for Class III devices to which the Quality System regulation violations are reasonably related will not be approved until the violations have been corrected. Requests for Certificates to Foreign Governments will not be granted until the violations related to the subject devices have been corrected.
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 occurring again. Include documentation of the corrections and/or corrective actions (including any systemic corrective actions) 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.
Your firm’s response should be sent to:
Lawton Lum, Director of Compliance
Food and Drug Administration
San Francisco District Office
1431 Harbor Bay Parkway
Alameda, CA 94502
Refer to the identification number 416360 when replying. We remind you that only written communications is considered as official. If you have any questions about the contents of this letter, please contact Russell A. Campbell, Compliance Officer at 510-337-6861 or firstname.lastname@example.org.
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 applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, Form 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.
Kathleen M. Lewis, J.D.
 The cleared indications for use are the same for PinPointe Touch Screen Laser and PinPointe Foot Laser.