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Sponsors, IRBs, and investigators, or any person acting on their behalf, are required to permit authorized FDA employees reasonable access at reasonable times to inspect and copy all records relating to an investigation. Any establishment where devices are held, including any establishment where devices are manufactured, processed, packed, installed, used, or implanted or where records of results from use of devices are kept, are subject to inspection. Furthermore, if FDA has reason to suspect that adequate informed consent was not obtained or that reports required to be submitted by the investigator to the sponsor or IRB have not been submitted or are incomplete, inaccurate, false, or misleading, FDA may inspect and copy records that identify subjects.
To assure compliance with the investigational device exemption (IDE) and related regulations, FDA inspects sponsors, clinical investigators, and institutional review boards. Nonclinical laboratories that perform animal studies in which the data are used to support research or marketing permits are included in the inspection program. The inspection program is referred to as bioresearch monitoring (BIMO) and is overseen by the CDRH's Office of Product Evaluation and Quality (OPEQ), Office of Clinical Evidence and Analysis (OCEA), DCEA1 (Division of Clinical Policy and Quality) or CBER's Office of Compliance and Biologics Quality, Division of Inspections & Surveillance, Bioresearch Monitoring Branch.
The regulations enforced by the bioresearch monitoring program for medical devices are found in four sections of the CFR:
- 21 CFR 812 - Investigational Device Exemptions
- 21 CFR 50 - Protection of Human Subjects
- 21 CFR 56 - Institutional Review Boards
- 21 CFR 58 - Good Laboratory Practice for Nonclinical Laboratory Studies
The objectives of the bioresearch monitoring program are to ensure the quality and integrity of data and information submitted in support of research and marketing permits that include IDE, PMA, and 510(k) submissions and to ensure that human subjects taking part in investigations are protected from undue hazard or risk. This is achieved through audits of clinical data contained in PMA’s prior to approval, data audits of IDE and 510(k) submissions, inspections of Institutional Review Boards and nonclinical laboratories, and enforcement of the prohibition against promotion, marketing, or commercialization of investigational devices.
In addition, the Division is also charged with the implementation of the FDA's Application Integrity Policy (AIP) for medical devices and radiological health products. If it is suspected that an applicant has submitted false or misleading information, the data are thoroughly investigated. Submitting false or misleading information may result in FDA refusal to review submissions until certain requirements are met, as well as the initiation of legal actions.
If FDA has information indicating that an investigator has repeatedly or deliberately failed to comply with the IDE, Informed Consent, or IRB requirements under 21 CFR 812, 21 CFR 50, or 21 CFR 56, or has repeatedly or deliberately submitted false information either to the sponsor of the investigation or in any required report, FDA will provide the investigator written notice of the matter under complaint and offer the investigator an opportunity to explain the matter in writing, or, at the option of the investigator, in an informal conference. If an explanation is offered from the investigator and accepted, the disqualification process will be terminated. If an explanation is offered but not accepted, the investigator will be given an opportunity for a regulatory hearing under 21 CFR 16 on the question of whether the investigator is entitled to receive investigational devices.
After evaluating all available information, including any explanation presented by the investigator, if FDA determines that the investigator has repeatedly or deliberately failed to comply with the requirements, or has deliberately or repeatedly submitted false information either to the sponsor of the investigation or in any required report, the FDA will notify the investigator, the sponsor of any investigation in which the investigator has been named as a participant, and the reviewing IRB that the investigator is not entitled to receive investigational devices. The notification will provide a statement of the basis for such determination.
An investigator who has been determined to be ineligible to receive investigational devices may be reinstated as eligible when FDA determines that the investigator has presented adequate assurances that the investigator will employ investigational devices solely in compliance with the IDE and related regulations.
Review of IDE and Marketing Applications
Each IDE and each cleared 510(k) or approved PMA application submitted that contains data reported by an investigator who has been determined to be ineligible to receive investigational devices will be examined to determine whether the investigator has submitted unreliable data that are essential to the continuation of the investigation or essential to the approval or clearance of any marketing application.
FDA will eliminate the unreliable data submitted by the investigator from consideration and review the remaining data. If FDA determines that the remaining data are inadequate to support a conclusion that it is reasonably safe to continue the investigation under IDE, FDA will notify the sponsor who will have an opportunity for a regulatory hearing. If a danger to the public health exists, however, FDA will terminate the IDE immediately and notify the sponsor and the reviewing IRB of the determination. In such a case, the sponsor will have an opportunity for a regulatory hearing before FDA on the question of whether the IDE should be reinstated. If FDA determines from the remaining data that the continued 510(k) clearance or PMA approval of the marketing application for which the data were submitted cannot be justified, FDA will proceed to withdraw approval or rescind clearance of the medical device.
- 21 CFR 812.119
- 21 CFR 812.145
- Compliance Program Guidance Manual For FDA Staff
- Compliance Program Guidance Manual For FDA Staff - Program 7348.808A
- CHAPTER 48 - 7348.809 Bioresearch Monitoring (PDF - 1.3MB)
- FDA Bioresearch Monitoring Information
- Application Integrity Policy
- Bioresearch Monitoring Agreement for PMAs and PDPs - February 23, 1998
- Bioresearch Monitoring General Information
- FDA Debarment List (Drug Product Applications)