(b) Sponsor records. A sponsor shall maintain the following accurate, complete, and current records relating to an investigation:

(1) All correspondence with another sponsor, a monitor, an investigator, an IRB, or FDA, including required reports.

(2) Records of shipment and disposition. Records of shipment shall include the name and address of the consignee, type and quantity of device, date of shipment, and batch number or code mark. Records of disposition shall describe the batch number or code marks of any devices returned to the sponsor, repaired, or disposed of in other ways by the investigator or another person, and the reasons for and method of disposal.

(3) Signed investigator agreements.

(4) For each investigation subject to § 812.2(b)(1) of a device other than a significant risk device, the records described in paragraph (b)(5) of this section and the following records, consolidated in one location and available for FDA inspection and copying:

(i) The name and intended use of the device and the objectives of the investigation;

(ii) A brief explanation of why the device is not a significant risk device:

(iii) The name and address of each investigator:

(iv) The name and address of each IRB that has reviewed the investigation:

(v) A statement of the extent to which the good manufacturing practice regulation in Part 820 will be followed in manufacturing the device; and

(vi) Any other information required by FDA.

(5) Records concerning adverse device effects (whether anticipated or unanticipated) and complaints and

(6) Any other records that FDA requires to be maintained by regulation or by specific requirement for a category of investigation or a particular investigation.

(c) IRB records. An IRB shall maintain records in accordance with Part 56 of this chapter.

(d) Retention period. An investigator or sponsor shall maintain the records required by this subpart during the in

vestigation and for a period of 2 years after the latter of the following two dates: The date on which the investigation is terminated or completed, or the date that the records are no longer required for purposes of supporting a premarket approval application or a notice of completion of a product development protocol.

(e) Records custody. An investigator or sponsor may withdraw from the responsibility to maintain records for the period required in paragraph (d) of this section and transfer custody of the records to any other person who will accept responsibility for them under this part, including the requirements of § 812.145. Notice of a transfer shall be given to FDA not later than 10 working days after transfer occurs. [45 FR 3751, Jan. 18, 1980, as amended at 45 FR 58843, Sept. 5, 1980; 46 FR 8957, Jan. 27, 1981]

§ 812.145 Inspections.

(a) Entry and inspection. A sponsor or an investigator who has authority to grant access shall permit authorized FDA employees, at reasonable times and in a reasonable manner, to enter and inspect 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).

(b) Records inspection. A sponsor, IRB, or investigator, or any other person acting on behalf of such a person with respect to an investigation, shall permit authorized FDA employees, at reasonable times and in a reasonable manner, to inspect and copy all records relating to an investigation.

(c) Records identifying subjects. An investigator shall permit authorized FDA employees to inspect and copy records that identify subjects, upon notice that 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.

8812.150 Reports.

(a) Investigator reports. An investigator shall prepare and submit the following complete, accurate, and timely reports:

(1) Unanticipated adverse device effects. An investigator shall submit to the sponsor and to the reviewing IRB a report of any unanticipated adverse device effect occurring during an investigation as soon as possible, but in no event later than 10 working days after the investigator first learns of the effect.

(2) Withdrawal of IRB approval. An investigator shall report to the sponsor, within 5 working days, a withdrawal of approval by the reviewing IRB of the investigator's part of an investigation.

(3) Progress. An investigator shall submit progress reports on the investigation to the sponsor, the monitor, and the reviewing IRB at regular intervals, but in no event less often than yearly.

(4) Deviations from the investigational plan. An investigator shall notify the sponsor and the reviewing IRB (see § 56.108(a) (3) and (4)) of any deviation from the investigational plan to protect the life or physical well-being of a subject in an emergency. Such notice shall be given as soon as possible, but in no event later than 5 working days after the emergency occurred. Except in such an emergency, prior approval by the sponsor is required for changes in or deviations from a plan, and if these changes or deviations may affect the scientific soundness of the plan or the rights, safety, or welfare of human subjects, FDA and IRB in accordance with § 812.35(a) also is required.

(5) Informed consent. If an investigator uses a device without obtaining informed consent, the investigator shall report such use to the sponsor and the reviewing IRB within 5 working days after the use occurs.

(6) Final report. An investigator shall, within 3 months after termination or completion of the investigation or the investigator's part of the investigation, submit a final report to the sponsor and the reviewing IRB.

(7) Other. An investigator shall, upon request by a reviewing IRB or

FDA, provide accurate, complete, and current information about any aspect of the investigation.

(b) Sponsor reports. A sponsor shall prepare and submit the following complete, accurate, and timely reports:

(1) Unanticipated adverse device effects. A sponsor who conducts an evaluation of an unanticipated adverse device effect under § 812.46(b) shall report the results of such evaluation to FDA and to all reviewing IRB's and participating investigators within 10 working days after the sponsor first receives notice of the effect. Thereafter the sponsor shall submit such additional reports concerning the effect as FDA requests.

(2) Withdrawal of IRB approval. A sponsor shall notify FDA and all reviewing IRB's and participating investigators of any withdrawal of approval of an investigation or a part of an investigation by a reviewing IRB within 5 working days after receipt of the withdrawal of approval.

(3) Withdrawal of FDA approval. A sponsor shall notify all reviewing IRB's and participating investigators of any withdrawal of FDA approval of the investigation, and shall do so within 5 working days after receipt of notice of the withdrawal of approval.

(4) Current investigator list. A sponsor shall submit to FDA, at 6-month intervals, a current list of the names and addresses of all investigators participating in the investigation. The sponsor shall submit the first such list 6 months after FDA approval.

(5) Progress reports. At regular intervals, and at least yearly, a sponsor shall submit progress reports to all reviewing IRB's. In the case of a significant risk device, the sponsor shall also submit progress reports to FDA.

(6) Recall and device disposition. A sponsor shall notify FDA and all reviewing IRB's of any request that an investigator return, repair, or otherwise dispose of any units of a device. Such notice shall occur within 30 working days after the request is made and shall state why the request was made.

(7) Final report. In the case of a significant risk device, the sponsor shall notify FDA within 30 working days of the completion or termination of the

investigation and shall submit a final report to FDA and all reviewing the IRB's and participating investigators within 6 months after completion or termination. In the case of a device that is not a significant risk device, the sponsor shall submit a final report to all reviewing IRB's within 6 months after termination or completion.

(8) Informed consent. A sponsor shall submit to FDA a copy of any report by an investigator under paragraph (a)(5) of this section of use of a device without obtaining informed consent, within 5 working days of receipt of notice of such use.

(9) Significant risk device determinations. If an IRB determines that a device is a significant risk device, and the sponsor had proposed that the IRB consider the device not to be a significant risk device, the sponsor shall submit to FDA a report of the IRB's determination within 5 working days after the sponsor first learns of the IRB's determination.

(10) Other. A sponsor shall, upon request by a reviewing IRB or FDA, provide accurate, complete, and current information about any aspect of the investigation.

[45 FR 3751, Jan. 18, 1980, as amended at 45 FR 58843, Sept. 5, 1980; 48 FR 15622, Apr. 12, 1983]

Procedures and criteria for review of investigational studies by an institutional review committee.

813.70 Review by institution. 813.79 Actions where review by an institutional review committee is inadequate.

AUTHORITY: Secs. 301, 501, 502, 520, 701, 704, 801 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331, 351, 352, 360j, 371, 374, 381).

SOURCE: 42 FR 58889, Nov. 11, 1977, unless otherwise noted.

Subpart A-General Provisions

§ 813.1 Scope.

(a) General. This part provides that intraocular lenses may be exempted from any of the requirements of the act enumerated in paragraph (b) of this section that would otherwise be applicable to the device, to permit investigational studies of the device by experts who are qualified by scientific training and experience to investigate the safety and effectiveness of the lenses. This part implements sections 520(g) and 520(1) of the act with respect to intraocular lenses.

(b) Effect of exemption. (1) In general, intraocular lenses are exempted from provisions of the following sections of the act and regulations thereunder when an application for exemption applicable to the lenses is in effect under this part: Misbranding under section 502, registration and premarket notification under section 510, performance standards under section 514, premarket approval under section 515, records and reports under section 519, restricted devices under section 520(e), good manufacturing practices under section 520(f), and color additives under section 706.

(2) Intraocular lenses shall not be extempted from a provision of the act listed in paragraph (b)(1) of this section where the Commissioner indicates that the lens is not exempt from such a provision in an order of disapproval, approval, or approval with modifications under § 813.30.

§ 813.2 Applicability.

This part applies to all implantations of intraocular lenses in humans unless a premarket approval application has been approved for these lenses under section 515 of the act.

§ 813.3 Definitions.

(a) Intraocular lens means a lens intended to replace surgically the natural lens of the human eye. An intra

ocular lens is, for purposes of this part, synonymous with "investigational device," lens, or lenses.

(b) Investigational device means a device that is used in an investigational study involving human subjects, where the study is for the purpose of determining if the device is safe or effective.

(c) Investigational plan means a plan or protocol for using an investigational device in an investigational study. See § 813.25 for requirements applicable to an investigational plan.

(d) Investigational study means a study involving human subjects when the study is for the purpose of determining if an investigational device is safe or effective and includes any implantation in a human of an intraocular lens for which there is no approved application for premarket approval under section 515 of the act.

(e) Investigator means an individual who actually conducts an investigational study, i.e., under whose immediate direction the investigational device is administered or dispensed to, or used involving, a subject.

(f) Monitor, when used as a noun, means an individual selected by a sponsor or contract research organization to oversee the progress of an investigational study. The monitor may be a full-time employee of a sponsor or contract research organization or a consultant to the sponsor or contract research organization. (Monitor, when used as a verb, means the act of reviewing the progress of an investigational study.)

(g) Sponsor means a person who initiates an investigational study, but who does not actually conduct the study (i.e., the investigational device is administered or dispensed to, or used involving, a subject under the immediate direction of another individual). A person other than an individual, e.g., corporation or government agency, that uses one or more of its own employees to conduct an investigational study that it has initiated is considered to be a sponsor (not a sponsor-investigator), and the employees are considered to be investigators.

(h) Sponsor-investigator means an individual who both initiates and actually conducts, alone or with others, an

investigational study (i.e., under whose immediate direction the investigational device is administered or dispensed to, or used involving, a subject). The term does not include any person other than an individual. Any sponsorinvestigator shall carry out the responsibilities under this part of a sponsor and of an investigator.

(i) Institution means a person (other than an individual) who engages in the conduct of research on human subjects or in the delivery of medical services to human subjects as a primary activity or as an adjunct to providing residential or custodial care to human beings. The term includes a hospital, retirement home, prison, university, or device manufacturer. Facility as used in section 520(g) of the act is deemed to by synonymous with the term institution for purposes of this part.

(j) Subject means an individual who is or becomes a paticipant in an investigational study, either as a recipient of the investigational device or as a control. A subject may be either a nonpatient volunteer or a patient on whom the intraocular lens might have a therapeutic effect.

(k) Person includes an individual, partnership, corporation, association, scientific establishment, government agency, and any other legal entity.

(1) Institutional review committee means a committee (appointed by an institution to review and monitor investigations in which human subjects participate) whose major responsibility is the protection of human subjects from risk to their health, safety, or dignity in accordance with the current professional standards and the requirements of this part. Such a committee may be known as an institutional review board or by other names. § 813.5 General qualifications for an exemption.

A shipment of an intraocular lens is exempt from any or all the otherwise applicable requirements of the act enumerated in § 813.1(b)(1) if all the following conditions are met:

(a) The label of the device bears the following: the name and place of business of the manufacturer, packer, or distributor in accordance with § 801.1

of this chapter; the quantity of contents; the sterility shelf life of the lens; and the statement, "Caution-investigational device. Limited by Federal (or United States) law to investigational use".

(b) The labeling of the intraocular lens is not false or misleading in any particular.

(c) (1) An application for investigational device exemption covering that shipment was submitted by the sponsor under Subpart B of this part, and the requisite time has elapsed following the date of receipt of the application by the Food and Drug Administration to permit the investigational study to begin under § 813.30(b).

(2) The Commissioner has not disapproved the application or withdrawn the exemption.

(3) Each shipment of the intraocular lens is made in accordance with the commitments in the application and any conditions imposed in the Commissioner's approval of the application.

(4) The sponsor has complied with the requirements of Subparts B, C, and G of this part, any institutional review committee that is to review and approve the investigational study for which shipment is made has complied with the requirements of Subparts D and G of this part, and the investigator(s) to which the shipment is to be made has complied with the requirements of Subparts E and G of this part and with the requirements for informed consent contained in Part 50 of this chapter.

(d) If the shipment is to be imported into or exported from the United States, the requirements of § 813.19 have been met.

[42 FR 58889, Nov. 11, 1977, as amended at 47 FR 46079, Oct. 15, 1982]

§ 813.10 Petitions for waiver of requirements.

(a) Any person subject to any requirement under this part may petition the Commissioner for a waiver of such requirement. Such a petition shall be submitted in accordance with § 10.30 of this chapter and shall set forth the basis for the petitioner's belief that compliance with the re