WARNING LETTER
John Meadors
MARCS-CMS 559611 —
October 15, 2018
Delivery Method:
VIA UNITED PARCEL SERVICE
Product:
Medical Devices
Recipient:
Recipient Name
John O. Meadors
John Meadors
Ideal Curves LLC
12458 Timberline Drive
Highland
,
UT
84003
United States
Issuing Office:
Center for Devices and Radiological Health
10903 New Hampshire Avenue
Silver Spring
,
MD
20993
United States
WARNING LETTER
October 15, 2018
Dear Dr. Meadors:
This Warning Letter is to inform you of objectionable conditions observed during the Food and Drug Administration (FDA) inspection conducted at your clinical site from April 30, 2018, to May 7, 2018, by investigators from the FDA’s Office of Bioresearch Monitoring Operations (OBIMO). This inspection was conducted to determine whether your activities and procedures as a clinical investigator in the clinical investigation “
(b)(4)
” (Protocol
(b)(4)
), Premarket Notification (510(k))
(b)(4)
, complied with applicable federal regulations.
(b)(4)
device is a device as that term is defined in section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), 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 or function of the body. This letter also requests prompt corrective action to address the violations cited.
The inspection was conducted under a program designed to ensure that data and information contained in requests for Investigational Device Exemptions (IDE), Premarket Approval applications, and (510(k)) submissions are scientifically valid and accurate. Another objective of the program is to ensure that human subjects are protected from undue hazard or risk during the course of scientific investigations.
Our review of the inspection report prepared by the OBIMO revealed serious violations of Title 21, Code of Federal Regulations (CFR) Part 812 - Investigational Device Exemptions and Part 50 - Protection of Human Subjects, which concerns requirements prescribed under section 520(g) of the Act, 21 U.S.C. § 360j(g). At the close of the inspection, the FDA investigator presented an Inspectional Observations Form FDA 483 for your review and discussed the observations listed on the form with you. The deviations noted on the Form FDA 483, and our subsequent review of the inspection report, are discussed below.
As clinical investigator, you are responsible for ensuring that the clinical investigation was conducted in accordance with the investigational plan and in compliance with FDA regulations, both to protect the rights, safety, and welfare of subjects and to ensure the validity and integrity of the clinical data. However, we have serious concerns with the conduct of your investigations under Protocol
(b)(4)
, including, but not limited to, not having Institutional Review Board (IRB) approval, lack of documented informed consent obtained from each subject, and failure to maintain adequate records of each subject’s exposure to the investigational device and outcomes in accordance with the investigational plan. Additionally, given that no source documents were available at your site, the validity and integrity of the data collected at your site and submitted for Protocol
(b)(4)
cannot be assured.
In addition, failure to obtain IRB approval for this investigation as a nonsignificant risk investigation constitutes conducting an investigation subject to the IDE requirements without an approved IDE and negates applicability of abbreviated requirements under 21 CFR 812.2(b), which allows certain investigations to proceed without prior FDA approval. Thus, your investigation activities are subject to the full requirements at 21 CFR Part 812.
However, whether a clinical investigation is conducted under the abbreviated requirements at 21 CFR 812.2(b) or is subject to prior FDA approval, compliance with FDA regulations relating to informed consent, IRB oversight, pertinent reports and recordkeeping is required, and you failed to adhere to applicable requirements governing the conduct of clinical investigations.
1. Failure to obtain IRB and FDA approval of the investigation. [21 CFR 812.110(a)]
A clinical investigator is required to obtain both IRB and FDA approval before requesting written informed consent from any subject and before allowing any subject to participate in an investigation. You failed to adhere to this regulation when you started your investigation without FDA and IRB approval. For example,
(b)(4)
. Further, records obtained during FDA’s inspection note that on November 1, 2017,
(b)(4)
. However, on November 3, 2017, you proceeded with the study and by November 6, 2017,
(b)(4)
subjects were treated. At no time during this investigation did you receive both FDA and IRB approval. Without IRB approval, there is no assurance that subject risks were minimized and reasonable in relation to anticipated benefits, and that additional safeguards for subjects were addressed.
2. Failure to ensure that informed consent was obtained in accordance with 21 CFR 50.27. [21 CFR 812.100]
In addition to getting IRB approval, a clinical investigator is responsible for ensuring that informed consent is obtained from each subject prior to allowing that subject to participate in the investigation. Informed consent is obtained when all applicable regulations are met, including the documentation of informed consent which requires collecting a written consent form approved by the reviewing IRB and signed and dated by each subject before the subject participates in the investigation. Informed consent is not obtained until this regulation is met (none of the exceptions apply here). You failed to adhere to these regulations when you could not produce documented informed consent from any of the subjects participating in the study.
(b)(4)
. The written consent form reportedly used was not specific to the study or approved by the IRB. This brings into question whether these subjects were afforded the opportunity to provide adequate, knowledgeable, informed consent. A valid informed consent process ensures that research subjects have a clear understanding of risks of participation in a research protocol, have sufficient opportunity to consider whether to participate in the study, and make an informed decision if they decide to participate.
3. Failure to maintain accurate, complete, and current records regarding the investigation. [21 CFR 812.140(a)(3) and 21 CFR 812.140(d)]
As a clinical investigator, you are responsible for preparing and maintaining adequate and accurate case histories that record all relevant observations and other data pertinent to the investigation on each individual administered the investigational device or employed as a control in the investigation. These records must include documents showing informed consent, relevant observations, and any adverse events. Records must be kept in one place and be available for FDA inspection for a period of 2 years after the latter date of either the date on which the investigation is terminated or completed, or the date that the records are no longer required for purposes of supporting the application. You failed to adhere to these regulations because you did not maintain, or produce for FDA inspectors, records for the subjects.
(b)(4)
.
Complete and accurate records allow FDA to verify certain data or validate the clinical investigation through onsite inspections. As such, adequate maintenance of study records is essential to ensuring that the clinical investigation was conducted in accordance with the investigational plan and applicable FDA regulations. This includes records confirming that the informed consent process was done appropriately; that any adverse events and safety concerns have been accurately recorded and evaluated; and records of all observations and data pertinent to the investigation such as device accountability.
4. Failure to conduct the investigation in accordance with the investigational plan. [21 CFR 812.100 and 812.110(b)]
As a clinical investigator, it is your responsibility to conduct the clinical investigation in accordance with the investigational plan, applicable FDA regulations, and any conditions of approval imposed by FDA and/or the IRB. You failed to adhere to the regulations by deviating from the study protocol and by violating numerous applicable FDA regulations concerning research on human subjects.
Investigational findings revealed that you departed from the investigational plan with regard to testing required by the study protocol, for example,
(b)(4)
, as specified by the protocol. In addition, as you
(b)(4)
.
The violations described above are not intended to be an all-inclusive list of problems that may exist with your clinical study. It is your responsibility as a clinical investigator to ensure compliance with the Act and applicable regulations.
Within 15 working days of receiving this letter, please provide documentation of the corrective and preventative actions that you have taken or will take to correct these violations and to prevent the recurrence of similar violations in current or future studies for which you are the clinical investigator. Failure to respond to this letter and take appropriate corrective action could result in the FDA taking regulatory action without further notice to you. In addition, FDA could initiate disqualification proceedings against you in accordance with 21 CFR 812.119.
You will find information to assist you in understanding your responsibilities and planning your corrective actions in the FDA Information Sheets Guidance for Institutional Review Boards and Clinical Investigators, which can be found at http://www.fda.gov/oc/ohrt/irbs/.  Any submitted corrective action plan must include projected completion dates for each action to be accomplished and a plan for monitoring the effectiveness of your corrective actions.
Your response should reference “
(b)(4)
” and be sent to:
Attention: Veronica J. Calvin
Branch Chief, BCB I
Food and Drug Administration
Center for Devices and Radiological Health
Office of Compliance
Division of Bioresearch Monitoring
10903 New Hampshire Avenue
Building 66, Room 3508
Silver Spring, Maryland 20993-0002
A copy of this letter has been sent to FDA’s OBIMO – West email at ORABIMOW.Correspondence@fda.hhs.gov. Please send a copy of your response to that office.
The Division of Bioresearch Monitoring has developed introductory training modules in FDA-regulated device clinical research practices, which are available on the FDA website. The modules are for persons involved in FDA-regulated device clinical research activities. These modules are located at the following website address: http://www.fda.gov/Training/CDRHLearn/.
If you have any questions, please contact Janette.Collins-Mitchell@fda.hhs.gov.
Sincerely yours,
/S/
Owen Faris, Ph.D.
Acting Director
Division of Bioresearch Monitoring
Office of Compliance
Center for Devices and Radiological Health
cc:
Densen B. Cao, Ph.D.
President/CEO
CAO Group, Inc
4628 W. Skyhawk Drive
West Jordan, UT 84084
Content current as of:
10/23/2018
Regulated Product(s)
Medical Devices