Source: https://www.federalregister.gov/documents/2003/06/16/03-15059/agency-information-collection-activities-submission-for-omb-review-comment-request-investigational
Timestamp: 2018-08-15 21:54:24
Document Index: 744444332

Matched Legal Cases: ['art 812', 'art 812', '§\u2009812', '§\u2009812', '§\u2009812', '§\u2009812', '§\u2009812']

Federal Register :: Agency Information Collection Activities; Submission for OMB Review; Comment Request; Investigational Device Exemptions Reports and Records
Agency Information Collection Activities; Submission for OMB Review; Comment Request; Investigational Device Exemptions Reports and Records
Submit written or electronic comments on the collection of information by July 16, 2003.
68 FR 35677
https://www.federalregister.gov/d/03-15059 https://www.federalregister.gov/d/03-15059
Section 520(g) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360j(g)) establishes the statutory authority to collect information regarding investigational devices and establishes rules under which new medical devices may be tested using human subjects in a clinical setting. The Food and Drug Administration Modernization Act of 1997 added section 520(g)(6) to the act and permitted changes to be made either to the investigational device or to the clinical protocol without FDA approval of an investigational device exemption (IDE) supplement.
An IDE allows a device, which would otherwise be subject to provisions of the act, such as premarket notification or premarket approval, to be used in investigations involving human subjects. The safety and effectiveness of the device involving human subjects is being studied. The purpose of part 812 (21 CFR part 812) is to encourage, to the extent consistent with the protection of public health and safety and with ethical standards, the discovery and development of useful devices intended for human use. The IDE regulation is designed to encourage the development of useful medical devices and allow investigators the maximum freedom possible, without jeopardizing the health and safety of the public or violating ethical standards.
Sections 812.20, 812.25, and 812.27 consist of the information necessary to file an IDE application with FDA. The submission of an IDE application to FDA is required only for significant risk device investigations. Section 812.20 lists the data requirements for the original IDE application; § 812.25 lists the contents of the investigational plan; and § 812.27 lists the data relating to previous investigations or testing. The information in this original IDE application is evaluated by the Center for Devices and Radiological Health to determine whether the proposed investigation will reasonably protect the public health and safety and for FDA to make a determination to approve the IDE.
Once FDA approves an IDE application, a sponsor must submit certain requests and reports. Under § 812.35, a sponsor who wishes to make a change in the investigation, which affects the scientific soundness of the study or the rights, safety, or welfare of the subjects, is required to submit a request for the change to FDA. Under § 812.150, a sponsor is required to submit reports to FDA. These requests and reports are submitted to FDA as supplemental applications. This information is needed for FDA to assure protection of human subjects and to allow review of the study's progress.
Section 812.36(c) identifies the information necessary to file a treatment IDE application. FDA uses this information to determine if wider distribution of the device is in the interests of the public health. Section Start Printed Page 35678812.36(f) identifies the reports required to allow FDA to monitor the size and scope of the treatment IDE, to assess the sponsor's due diligence in obtaining marketing clearance of the device, and to ensure the integrity of the controlled clinical trials.
Section 812.140 lists the recordkeeping requirements for investigators and sponsors. FDA requires this information for tracking and oversight purposes. Investigators are required to maintain records, including correspondence and reports concerning the study; records of receipt, use or disposition of devices; records of each subject's case history and exposure to the device; informed consent documentation; study protocol and documentation of any deviation from the protocol. Sponsors are required to maintain records, including correspondence and reports concerning the study; records of shipment and disposition; signed investigator agreements; adverse device effects information; and, for a nonsignificant risk device study, an explanation of the nonsignificant risk determination, records on device name and intended use, study objectives, investigator information, investigational review board (IRB) information, and statement on the extent that good manufacturing practices will be followed.
In the Federal Register of March 12, 2003 (68 FR 11868), FDA published a 60-day notice requesting public comment on the information collection provisions. No comments were received.
Sections 812.20, 812.25, and 812.27 estimates are based on the average of IDEs submitted from fiscal years 1995 through 2002. FDA estimates the annual reporting burden for one IDE original application to be approximately 80 hours and the annual reporting burden for one IDE supplement to be approximately 6 hours.
The reporting burden for nonsignificant risk device studies (§ 812.150) is negligible. Nonsignificant risk device studies are not reported to FDA unless a problem is reported such as, an unanticipated adverse device reaction, failure to obtain informed consent, withdrawal of IRB approval, or a recall of a device. In the past, an Start Printed Page 35679average of 10 incidences or less annually have been reported to FDA.
Section 812.40 estimates are based on conversations with manufacturers, industry trade association groups, and businesses over the last 3 years. For significant risk device investigations, FDA has estimated that the recordkeeping burden for preparing an original IDE submission averages 10 hours for each original IDE submission. Similarly, through the same conversations previously mentioned, FDA has estimated recordkeeping for each supplement requires 1 hour. The recordkeeping burden for nonsignificant risk device investigations is difficult to estimate because nonsignificant risk device investigations are not required to be submitted to FDA. The IDE staff estimates that the number of recordkeepers for nonsignificant risk device investigations is equal to the number for active significant risk device
investigations. The recordkeeping burden, however, is reduced for device nonsignificant risk studies. It is estimated that 600 recordkeepers will spend 6 hours each in maintaining these records.
[FR Doc. 03-15059 Filed 6-13-03; 8:45 am]