Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Baltimore District Office
6000 Metro Drive
Baltimore, MD 21201-2199
Telephone: (410) 779-5455
FAX: (410) 779-5705
CDRH Warning Letter
October 1, 2014
Mr. Donald M. Polsky, CEO
Electronic Development Labs, Inc.
244 Oakland Drive
Danville, VA 24540-7342
Dear Mr. Polsky:
During an inspection of your firm on October 29-31, 2013 and November 5, 2013, located at 244 Oakland Drive, in Danville, VA 24540, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the device Nervo-Scope. 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 to affect the structure orany function of the body.
Our inspection revealed that your firm's the Nervo-Scope devices are 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 U.S.C.§ 360i, and 21 CFR Part 803- Medical Device Reporting. Significant violations include, but are not limited to:
Failure to adequately develop, maintain and implement written MDR procedures, as required by 21 CFR 803.17.
For example: During the recent inspection of your firm your management staff informed the FDA Investigator that your firm does not have an MDR procedure.
The adequacy of your firm's response dated November 20, 2013, cannot be determined at this time. Your firm's response indicates that the development of an MDR procedure was added to a list of action items. In order to determine adequacy, FDA must receive a copy of the MDR procedure for review.
The eMDR Final Rule requiring manufactures 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 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.
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 (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 shouldbe sent to: U.S. Food and Drug Administration, Attention: Evelyn Bonnin, District Director, at 6000 Metro Drive, Suite 101, Baltimore, MD 21215. When replying, refer to the Unique Identification Number CMS #385318. If your firm has any questions about the contents of this letter, please contact CDR Rochelle B. Young, RPh, MSA, Compliance Officer at 410-779-5437 via telephone or 410-779-5703 via fax.
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, FDA483, 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.
Baltimore District Office