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sons be impossible on a regular basis with the available staff, the analysis should be done for a 2-week period after major changes have occurred in diagnostic procedures or the x-ray system and at least semi-annually.

(6) Records. The program should include provisions for the keeping of records on the results of the monitoring techniques, any difficulties detected, the corrective measures applied to these difficulties, and the effectiveness of these measures. The extent and form of these records should be determined by the facility on the basis of its needs. The facility should view these records as a tool for maintaining an effective quality assurance program and not view the data in them as an end in itself but rather as a beginning. For example, the records should be made available to vendors to help them provide better service. More importantly, the data should be the basis for the evaluation and the reviews suggested in paragraphs (c)(5) and (10) of this section.

(7) Manual. A quality assurance manual should be written in a format permitting convenient revision as needed and should be made readily available to all personnel. The content of the manual should be determined by the facility staff, but the following items are suggested as providing essential information:

(i) A list of the individuals responsible for monitoring and maintenance techniques.

(ii) A list of the parameters to be monitored and the frequency of monitoring.

(iii) A description of the standards, criteria of quality, or limits of acceptability that have been established for each of the parameters monitored.

(iv) A brief description of the procedures to be used for monitoring each parameter.

(v) A description of procedures to be followed when difficulties are detected to call these difficulties to the attention of those responsible for correcting them.

(vi) A list of the publications in which detailed instructions for monitoring and maintenance procedures can be found. Copies of these publications should also be readily available

to the entire staff, but they should be separate from the manual. (Publications providing these instructions can 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

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members should participate in the committee's tasks. The Quality Assurance 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 re

quired 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]

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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.

AUTHORITY: Secs. 502, 510, 519, 520, 531-542, 701, 704 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352, 360, 3601, 360j, 360hh36088, 371, 374).

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

Subpart A-General Provisions

$1002.1 Applicability.

The provisions of this part are applicable as follows:

(a) All manufacturers of electronic products are subject to § 1002.20.

(b) Manufacturers, dealers, and distributors of electronic products are

subject to the provisions of part 1002 as set forth in Table 1 of this section, unless excluded by paragraph (c) of this section, or unless an exemption has been granted under §1002.50 or $1002.51.

(c) The requirements of part 1002 as specified in Table 1 of this section are not applicable to:

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

(2) Manufacturers of electronic products listed in Table 1of this section if such product is sold exclusively to other manufacturers for use as components of electronic products 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.

(3) Manufacturers of electronic products that 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.

(4) 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 (d)(2) of this chapter and retains a copy of such report for a period of 5 years from its date.

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Products

TABLE 1.-Record and Reporting Requirements By Product-Continued

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X

X

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Class IIa, II, Illa lasers and products other than class I products X X
containing such lasers?

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However, authority to inspect all appropriate documents supporting the adequacy of a manufacturer's compliance testing program is retained. 2The requirement includes §§1002.31 and 1002.42, if applicable.

Report of Assembly (Form FDA 2579) is required for diagnostic x-ray components; see 21 CFR 1020.30(d)(1) through (d)(3).

4Systems records and reports are required if a manufacturer exercises the option and certifies the system as permitted in 21 CFR 1020.30(c). "Determined using the isoexposure rate limit curve (IRLC) under phase III test conditions (1020.10(c)(3)(iii)).

"Determination of the applicable reporting category for a laser product shall be based on the worst-case hazard present within the laser product.

X

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