Inspections, Compliance, Enforcement, and Criminal Investigations
Micromed Technology, Inc
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
|10903 New Hampshire Avenue
Silver Spring, MD 20993
DEC 15 2009
VIA FEDERAL EXPRESS
Chief Executive Officer
MicroMed Technology, Inc.
8965 Interchange Drive
Houston, TX 77054
RE: DeBakey VAD Child
Refer to EC090307 when replying to this letter.
Dear Mr. Birdsall,
During an inspection of your firm located in Houston, Texas on July 27 through August 6, 2009, investigators from the United States Food and Drug Administration (FDA) determined that your firm manufactures DeBakey VAD Child. 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 are intended to affect the structure or function of the body.
This inspection revealed that your DeBakey VAD Child 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 any material or information respecting the device that is required by or under section 519, 21 U.S.C. § 360i, and 21 CFR Part 803 (Medical Device Reporting regulation). Significant deviations include, but are not limited to, the following:
1. Failure to submit reports required in our approval of the modification for reporting adverse events as required by 21 CFR 803.19(e). Specifically, your firm is participating in the INTERMACS registry which allows for submission of MDR reports for our approval within 90 days, but no evidence of your firm's submission of MDR reports for our review within 90 days was available.
2. Failure to report to the 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 your marketed device may have caused or contributed to a death or serious injury as required by 21 CFR 803.50(a)(1). As stated previously, your firm is participating in the INTERMACS registry which allows for submission of MDR reports for our approval within 90 days, but no evidence or your firm's submission or MDR reports for our review within 90 days was available.
3. Failure to report to the 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 your marketed device malfunctioned and that this device or a similar device, marketed, would be likely to cause or contribute to a death or serious injury if the malfunction were to reoccur as required by 21 CFR 803.50(a)(2). As stated previously, your firm is participating in the INTERMACS registry which allows for submission of MDR reports for our approval within 90 days, but no evidence of your firm's submission of MDR reports for our review within 90 days was available.
4. Failure to implement written MDR procedures for internal systems that provide for timely and effective identification, communication, and evaluation of events that may be subject to MDR requirements as required by 21 CFR 803.17.
You 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 Food and Drug Administration without further notice. These actions include, but arc not limited to, seizure. injunction, and/or civil money penalties. Also. federal agencies arc advised or the issuance of all 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) working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan 10 prevent these violations, or similar violations. from occurring again. Include documentation of the corrective action you have taken. If your planned corrections will occur over lime, please include a timetable for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.
Your response should be sent to Dorothy Lee, Branch Chief Food and Drug Administration, Office of Compliance, W066 Room 3668,10903 New Hampshire Avenue, Silver Spring, MO 20993. If you have any questions about the content of this letter please contact Daniel Walter at (301) 796-5587 or facsimile at (301) 847-8138.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your facility. It is your 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 (FDA 483), issued at the closeout of the inspection may be symptomatic of serious problems in your firm's manufacturing and quality assurance systems. You should investigate and determine the causes of the violations and take prompt actions to correct the violations and to bring your products into compliance.
Timothy A. Ulatowski
Office of Compliance
Center for Devices and