Daily Rules, Proposed Rules, and Notices of the Federal Government


Food and Drug Administration

[Docket No. FDA-2012-N-0477]

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Investigational Device Exemptions Reports and Records

AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
SUMMARY: The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by January 2, 2013.
ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, Fax: 202-395-7285, or emailed comments should be identified with the OMB control number 0910-0078. Also include the FDA docket number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Daniel Gittleson, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, MD 20850, 301-796-5156,

In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.

Investigational Device Exemptions Reports and Records—(OMB Control Number 0910-0078)—Extension

Section 520(g) of the Federal Food, Drug, and Cosmetic Act (the FD&C 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 (Pub. L. 105-115) added section 520(g)(6) to the FD&C Act and permitted changes to be made to either 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 FD&C Act, such as premarket notification or premarket approval, to be used in investigations involving human subjects in which the safety and effectiveness of the device 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. To do this, the regulation provides for different levels of regulatory control, depending on the level of potential risk the investigational device presents to human subjects. Investigations of significant risk devices, ones that present a potential for serious harm to the rights, safety, or welfare of human subjects, are subject to the full requirements of the IDE regulation. Nonsignificant risk device investigations, i.e., devices that do not present a potential for serious harm, aresubject to the reduced burden of the abbreviated requirements. The regulation also includes provisions for treatment IDEs. The purpose of these provisions is to facilitate the availability, as early in the device development process as possible, of promising new devices to patients with life-threatening or serious conditions for which no comparable or satisfactory alternative therapy is available. Section 812.10 permits the sponsor of the IDE to request a waiver to all of the requirements of part 812. This information is needed for FDA to determine if waiver of the requirements of part 812 will impact the public's health and safety. 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 the 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.

Upon approval of an IDE application by FDA, a sponsor must submit certain requests and reports. Under § 812.35, a sponsor who wishes to make a change in the investigation that 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. Section 812.150 requires a sponsor 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 interest of the public health. Section 812.36(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 of device name and intended use, study objectives, investigator information, investigational review board information, and statement on the extent that good manufacturing practices will be followed.

For a nonsignificant risk device investigation, the investigator's and sponsor's recordkeeping and reporting burden is reduced. Pertinent records on the study must be maintained by both parties, and reports are made to sponsors and institutional review boards (IRBs). Reports are made to FDA only in certain circumstances, e.g., recall of the device, the occurrence of unanticipated adverse effects, and as a consequence of certain IRB actions.

The estimate of the burden is based on the number of IDEs received in the last 3 years. In theFederal Registerof May 24, 2012 (77 FR 31022), FDA published a 60-day notice requesting public comment on the proposed collection of information. FDA received two comments, one of which was outside the scope of the four collection of information topics on which the notice solicited comments and will not be discussed in this document. The other comment recommends streamlining the annual IDE report requirements to focus on the reporting of safety information only, rather than both safety and effectiveness. The comment notes that the effectiveness information is “reviewed during FDA clinical site GCP compliance inspections” and at the time of premarket application. FDA recognizes that part 812 provides limited information on the content of IDE annual reports; however, we believe that the specific content requirements for IDE annual reports are outside the scope of this PRA renewal notice. Section 812.150(b)(10) provides broad authority for FDA to request information regarding ongoing IDEs, and FDA will consider the need for additional guidance to IDE sponsors regarding the content of annual reports.

FDA estimates the burden of this collection of information as follows:

Table 1—Estimated Annual Reporting Burden1 Activity/21 CFR Section Number of
  • respondents
  • Number of
  • responses per respondent
  • Total annual responses Average
  • burden per
  • response
  • Total hours
    Waivers—812.10 1 1 1 1 1 IDE Application—812.20, 812.25, and 812.27 356 1 356 80 28,480 Supplements—812.35 and 812.150 356 12 4,272 6 25,632 Treatment IDE Applications—812.36(c) 1 1 1 120 120 Treatment IDE Reporting—812.36(f) 1 1 1 20 20 Total 54,253 1There are no capital costs or operating and maintenance costs associated with this collection of information.
    Table 2—Estimated Annual Recordkeeping Burden1 Activity/21 CFR Section Number of
  • recordkeepers
  • Number of
  • records per recordkeeper
  • Total annual records Average
  • burden per
  • recordkeeping
  • Total hours
    Original—812.140 356 1 356 10 3,560 Supplemental—812.140 356 12 4,272 1 4,272 Nonsignificant—812.140 356 1 356 6 2,136 Total 9,968 1There are no capital costs or operating and maintenance costs associated with this collection of information.
    Table 3—Estimated Annual Third-Party Disclosure Burden1 Activity/21 CFR Section Number of
  • respondents
  • Number of
  • disclosures per
  • respondent
  • Total annual disclosures Average
  • burden per
  • disclosure
  • Total hours
    Reports for Nonsignificant Risk Studies—812.150 1 1 1 6 6 1There are no capital costs or operating and maintenance costs associated with this collection of information.
    Dated: November 27, 2012. Leslie Kux, Assistant Commissioner for Policy.