usually be obtained from FDA or private sources, although the facility may wish to make some modifications to meet its needs more effectively.)

(vii) A list of the records, with sample forms, that the facility staff has decided should be kept. The facility staff should also determine and note in the manual the length of time each type of record should be kept before discarding.

(viii) A copy of each set of purchase specifications developed for new equipment and the results of the acceptance testing for that equipment.

(8) Training. The program should include provisions for appropriate training for all personnel with quality assurance responsibilities. This should include both training provided before the quality assurance responsibilities are assumed and continuing education to keep the personnel up-to-date. Practical experience with the techniques conducted under the supervision of experienced instructors, either in the facility or in a special program, is the most desirable type of training. The use of self-teaching materials can be an adequate substitute for supervised instruction, especially in continuing education programs, if supervised instruction is not available.

(9) Committee. A facility whose size would make it impractical for all staff members to meet for planning purposes should consider the establishment of a quality assurance committee whose primary function would be to maintain lines of communication among all groups with quality assurance and/or image production or interpretation responsibilities. For maximum communication, all departments of the facility with x-ray equipment should be represented. The committee may also be assigned policy-making duties such as some or all of the following:

Assign quality assurance responsibilities; maintain acceptable standards of quality; periodically review program effectiveness, etc. Alternatively, the duties of this committee could be assigned to an already-existing committee such as the Radiation Safety Committee. In smaller facilities, all staff members should participate in the committee's tasks. The Quality Assur

ance Committee should report directly to the head of the radiology department, or, in facilities where more than one department operates x-ray equipment, to the chief medical officer of the facility. The committee should meet on a regular basis.

(10) Review. The facility's quality assurance program should be reviewed by the Quality Assurance Committee and/or the practitioner in charge to determine whether its effectiveness could be improved. Items suggested for inclusion in the review include:

(i) The reports of the monitoring and maintenance techniques to ensure that they are being performed on schedule and effectively. These reports should be reviewed at least quarterly.

(ii) The monitoring and maintenance techniques and their schedules to ensure that they continue to be appropriate and in step with the latest developments in quality assurance. They should be made current at least annually.

(iii) The standards for image quality to ensure that they are consistent with the state-of-the-art and the needs and resources of the facility. These standards should be evaluated at least annually.

(iv) The results of the evaluations of the effectiveness of the quality assurance actions to determine whether changes need to be made. This determination should be made at least annually.

(v) The quality assurance manual should also be reviewed at least annually to determine whether revision is needed.

[44 FR 71737, Dec. 11, 1979]

§ 1000.60 Recommendation on administratively required dental x-ray examinations.

(a) The Food and Drug Administration recommends that dental x-ray examinations be performed only after careful consideration of the dental or other health needs of the patient, that is, when the patient's dentist or physician judges them to be necessary for diagnosis, treatment, or prevention of disease. Administratively required dental x-ray examinations are those

required by a remote third party for reasons not related to the patient's immediate dental needs. These x-ray examinations are usually a source of unnecessary radiation exposure to the patient. Because any unnecessary radiation exposure should be avoided, third parties should not require dental x-ray examinations unless they can demonstrate that such examinations provide a direct clinical benefit to the patient, and the patient's dentist or physician agrees with that assessment.

(b) Some examples of administrative x-ray examinations that should not be required by third parties are those intended solely:

(1) To monitor insurance claims or detect fraud;

(2) To satisfy a prerequisite for reimbursement;

(3) To provide training or experience;

(4) To certify qualifications or competence.

(c) This recommendation is not intended to preclude dental x-ray examinations ordered by the attending practitioner, based on the patient's history or physical examination, or those performed on selected populations shown to have significant yields of previously undiagnosed disease. This recommendation is also not intended to preclude the administrative use by third parties of dental radiographs that are taken on the order of the patient's dentist or physician as a necessary part of the patient's clinical care.

[45 FR 40978, June 17, 1980]

Sec.

Subpart C-Manufacturers' Reports on Accidental Radiation Occurrences

1002.20 Reporting of accidental radiation

Occurrences.

Subpart D-Manufacturers' Records

1002.30 Records to be maintained by manufacturers.

1002.31 Preservation and inspection of records.

Subpart E-Dealer and Distributor Records 1002.40 Records to be obtained by dealers and distributors.

1002.41 Disposition of records obtained by dealers and distributors.

1002.42 Confidentiality of records furnished by dealers and distributors.

Subpart F—Exemptions From Records and
Reports Requirements

1002.50 Special exemptions.

1002.51 Exemptions for manufacturers of products intended for the U.S. Government.

Subpart G-Codes for Reporting Listed Electronic Products

1002.61 List of specific product groups.

AUTHORITY: Secs. 502, 510, 519, 520, 701, 704 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352, 360, 360i. 360j, 371, 374); secs. 354-360F of the Public Health Service Act (42 U.S.C. 263b-263n).

SOURCE: 38 FR 28625, Oct. 15, 1973, unless otherwise noted.

Subpart A-General Provisions § 1002.1 Applicability.

The provisions of this part are applicable to manufacturers, dealers, and distributors of electronic products as specified herein, but, except for § 1002.20, are not applicable to:

(a) Manufacturers of electronic products intended solely for export if such product is labeled or tagged to show that the product is intended for export, and the product meets all the applicable requirements of the country to which such product is intended for export:

(b) Manufacturers of electronic products listed in § 1002.61 if sold exclusively to other manufacturers for use as components of electronic prod

ucts to be sold to purchasers, with the exception that the provisions are applicable to those manufacturers certifying components of diagnostic x-ray systems pursuant to provisions of § 1020.30(c) of this chapter.

(c) Manufacturers of electronic products which are intended for use by the U.S. Government and whose function or design cannot be divulged by the manufacturer for reasons of national security, as evidenced by government security classification.

(d) Assemblers of diagnostic x-ray equipment subject to the provisions of § 1020.30(d) of this chapter, provided the assembler has submitted the report required by § 1020.30(d) (1) or (2) of this chapter and retains a copy of such report for a period of five years from its date.

[38 FR 31828, Nov. 19, 1973]

§ 1002.2

Definitions.

As used in this part:

(a) The term "dealer" means а person engaged in the business of offering electronic products for sale to purchasers, without regard to whether such person is or has been primarily engaged in such business, and includes persons who offer such products for lease or as prizes or awards.

(b) The term "distributor" means a person engaged in the business of offering electronic products for sale to dealers without regard to whether such person is or has been primarily or customarily engaged in such business.

(c) The term “purchaser" means the first person who, for value, or as an award or prize, acquires an electronic product for purposes other than resale, and also includes a person who leases an electronic product for purposes other than subleasing.

(d) The term "accidental radiation occurrence" means a single event or series of events occurring in the course of the manufacturing, testing, or use of any electronic product which has resulted in injurious or potentially injurious exposure of any person to electronic product radiation as a direct result of the manufacturing, testing, or use of that product.

(e) The term "model" means any identifiable, unique electronic product design, and refers to products having

the same structural and electrical design characteristics and to which the manufacturer has assigned a specific designation to differentiate between it and other products produced by that manufacturer.

§ 1002.3 Records and reports on components.

Records and reports required for products listed in § 1002.61 shall include information on all components which the manufacturer may provide with the listed product and which affect the quantity, quality, or direction of the radiation emissions.

§ 1002.4 Confidentiality of information.

The Secretary or his representative shall not disclose any information reported to or otherwise obtained by him, pursuant to this part, which concerns or relates to a trade secret or other matter referred to in section 1905 of title 18 of the United States Code, except that such information may be disclosed to other officers or employees of the Department and of the other agencies concerned with carrying out the requirements of the Act. Nothing in this section shall authorize the withholding of information by the Secretary, or by any officers or employees under his control, from the duly authorized committees of the Congress.

§ 1002.7 Submision of data and reports.

All submissions such as reports, test data, product descriptions, and other information required by this part, or voluntarily submitted to the Director, Center for Devices and Radiological Health, shall be filed with the number of copies as prescribed by the Director, Center for Devices and Radiological Health, and shall be signed by the person making the submission.

(a) In addition to the requirements of this part, all material submitted to the Director, Center for Devices and Radiological Health, shall be submitted pursuant to the provisions of Part 20-Public Information, of this chapter.

(b) Where guides or instructions have been issued by the Director, Center for Devices and Radiological

40-073 0-90--15

Health, for the submission of material required by this part such as test data, initial and annual reports, and reports of model changes, the material submitted shall conform to the applicable reporting guide or instruction to the extent that it is possible or appropriate to do so. Where it is not feasible or where it would not be appropriate to conform to any portion of a prescribed reporting guide or instruction, an alternate format for providing the information requested by that portion of the guide or instruction may be used provided the submitter of such information submits adequate explanation and justification for use of an alternate format. If the Director, Center for Devices and Radiological Health, determines that such justification is inadequate and that it is feasible or appropriate to conform to the prescribed reporting guide or instruction, he may require resubmission of the information in conformance with the reporting guide or instruction.

[42 FR 18062, Apr. 5, 1977, as amended at 53 FR 11254, Apr. 6, 1988]

Every manufacturer of a product listed under § 1002.61, shall submit an initial report to the Director, Center for Devices and Radiological Health, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, in accordance with this section. The report shall be submitted within 90 days following the effective date of listing such product under § 1002.61 or prior to the introduction of such product into commerce, whichever is later. The report shall be distinctly marked "Initial Report of (Name of Manufacturer)" and shall:

(a) State in the report for each model of a listed product whether the report is submitted pursuant to paragraph (a), (b), or (c) of § 1002.61.

(b) Identify each model of the listed product together with sufficient information concerning the manufacturer's code or other system of labeling suffi

cient to enable the Secretary to determine the place of manufacture.

(c) Describe the function, operational characteristics affecting radiation emissions, and intended and known uses of each model of the listed product.

(d) State the standards or design specifications, if any, for each model with respect to electronic product radiation safety. Reference may be made to a Federal standard, if applicable.

(e) For each model, describe the physical or electrical characteristics such as shielding, or electronic circuitry, etc., incorporated into the product in order that the standards or specifications reported pursuant to paragraph (d) of this section are met.

(f) Describe the methods and procedures employed, if any, in testing and measuring each model with respect to electronic product radiation safety including the control of unnecessary, secondary, or leakage electronic product radiation, the applicable quality control procedures used for each model, and the basis for selecting such testing and quality control procedures.

(g) For those products which may produce increased radiation with aging, describe the methods and procedures used, and frequency of testing each model for durability and stability with respect to electronic product radiation safety. Include the basis for selecting such methods and procedures, or for determining that such testing and quality control procedures are not necessary.

(h) Provide sufficient results of the testing and measuring of electronic product radiation safety and of the quality control procedures described in accordance with paragraphs (f) and (g) of this section to enable the Secretary to determine the effectiveness of the methods and procedures used to accomplish the stated purposes.

(i) Report for each model, all warning signs, labels and instructions, for installation, operation, and use which relate to electronic product radiation safety.

(j) Provide upon request such other information as the Secretary may reasonably require to enable him to determine whether the manufacturer has

acted or is acting in compliance with the Act and any standards prescribed thereunder, and to enable the Secretary to carry out the purposes of the Act.

[38 FR 28625, Oct. 15, 1973, as amended at 39 FR 16228, May 8, 1974; 40 FR 10175, Mar. 5, 1975; 53 FR 11254, Apr. 6, 1988]

§ 1002.11 Annual reports.

(a) Every manufacturer of products listed under § 1002.61(b) and (c) shall submit an annual report summarizing the contents of the records required to be maintained by § 1002.30(a).

(b) The first annual report shall be submitted by September 1, 1971, with subsequent reports due annually thereafter. Such reports shall cover the 12-month period ending on June 30 preceding the due date of the report.

§ 1002.12 Reports of model changes.

Prior to the introduction into commerce of a new or modified model of a product listed in § 1002.61 for which an initial report under § 1002.10 was required, each manufacturer shall submit a report with respect to such new or modified model containing any changes in the information submitted in the initial report.

Subpart C-Manufacturers' Reports on Accidental Radiation Occurrences

§ 1002.20 Reporting of accidental radiation occurrences.

(a) Manufacturers of electronic products shall, where reasonable grounds for suspecting that such an incident has occurred, immediately report to the Director, Center for Devices and Radiological Health, all accidental radiation occurrences reported to or otherwise known to the manufacturer and arising from the manufacturing, testing, or use of any product introduced or intended to be introduced into commerce by such manufacturer. Reasonable grounds include, but are not necessarily limited to, pro

fessional, scientific, or medical facts or opinions documented or otherwise, that conclude or lead to the conclusion that such an incident has occurred.

(b) Such reports shall be addressed to the Director, Center for Devices and Radiological Health, 5600 Fishers Lane, Rockville, MD 20857, and the reports and their envelopes shall be distinctly marked "Report on § 1002.20" and shall contain all of the following information where known to the manufacturer:

(1) The nature of the accidental radiation occurrence;

(2) The location at which the accidental radiation occurrence occurred;

(3) The manufacturer, type, and model number of the electronic product or products involved;

(4) The circumstances surrounding the accidental radiation occurrence, including causes;

(5) The number of persons involved, adversely affected, or exposed during the accidental radiation occurrence, the nature and magnitude of their exposure and/or injuries and, if requested by the Director, Center for Devices and Radiological Health, the names of the persons involved;

(5) The actions, if any, which may have been taken by the manufacturer, to control, correct, or eliminate the causes and to prevent reoccurrence; and

(7) Any other pertinent information with respect to the accidental radiation occurrence.

(c) If a manufacturer is required to report to the Director under paragraph (a) of this section and also is required to report under Part 803 of this chapter, the manufacturer shall report in accordance with Part 803. If a manufacturer is required to report to the Director under paragraph (a) of this section and is not required to report under Part 803, the manufacturer shall report in accordance with paragraph (a) of this section.

[38 FR 28625, Oct. 15, 1973 and 49 FR 36351, Sept. 14, 1984; 53 FR 11254, Apr. 6, 1988]