Description
This letterstates the Food and Drug Administration's (FDA) position regarding certain questions which arose after performance standards for CT systems were published. This letter supersedes the March 25, 1985, letter on the same subject.
Scope & Applicability
Product Classes
10Subject of the performance standard
Specialized application system.
Classified as other than general purpose
X-ray system limited by design to specific body regions or specialized applications.
X-ray system not limited by design to specific anatomical regions or specialized applications.
Requires specific reporting procedures
Requires specific reporting procedures
Electronic product designed for irradiation of the human body for diagnosis; Equipment subject to radiation control regulations and assembly reporting.
Instructions for mobile mode installation of CT scanners
Guidance for manufacturers of diagnostic x-ray equipment regarding radiation control regulations.; Subject of the radiation control regulations; Clarification of Radiation Control Regulations For Manufacturers of Diagnostic X-Ray Equipment; General category of equipment covered by the guidance; subject of the radiation control regulations
Stakeholders
6Entity responsible for installing and testing diagnostic x-ray systems.; Person engaged in assembling, replacing, or installing components into a diagnostic x-ray system.; Person or entity responsible for installing and testing x-ray components.; Person or entity responsible for installing x-ray components; Individual or firm responsible for installing and reporting x-ray equipment
Licensed individual who orders the use of the prescription device
Entity responsible for submitting NDINs
Person whose actions may cause a product to be deemed adulterated
Must comply with registration if meeting facility/responsible person definitions
Entity responsible for generating quality control records at foreign factories.
Regulatory Context
Attributes
5Specific topic of importance for diagnostic x-ray equipment.; Required on identification labels in Month and Year format.; Determines which performance standards are applicable; required on identification labels
SID used to define specialized applications for chest or spinal radiography.
Source-to-Image Distance
Includes peak tube potential, tube current, and exposure time
Unique identifier for instruments and probes.
Identified Hazards
Hazards
1Risks addressed by regulatory alternatives for modifications.
Related CFR Sections (11)
- 21CFR1002.10§ 1002.10 Product reports.
Every manufacturer of a product or component requiring a product report as set forth in table 1 of § 1002.1 shall submit a product report to the Food and Drug Administration, Center for Devices and Radiological Health, ATTN: Electronic Product Reports, Document Mail Center, 10903 New Hampshire Ave.,Read full regulation →
- 21CFR1020.30§ 1020.30 Diagnostic x-ray systems and their major components.
(a) Applicability.Read full regulation →
- 21CFR1020.33§ 1020.33 Computed tomography (CT) equipment.
(a) Applicability.Read full regulation →
- 21CFR1020.31§ 1020.31 Radiographic equipment.
The provisions of this section apply to equipment for radiography, except equipment for fluoroscopic imaging or for recording images from the fluoroscopic image receptor, or computed tomography x-ray systems manufactured on or after November 29, 1984.Read full regulation →
- 21CFR1020.32§ 1020.32 Fluoroscopic equipment.
The provisions of this section apply to equipment for fluoroscopic imaging or for recording images from the fluoroscopic image receptor, except computed tomography x-ray systems manufactured on or after November 29, 1984.Read full regulation →
- 21CFR1002.20§ 1002.20 Reporting of accidental radiation occurrences.
(a) Manufacturers of electronic products shall, where reasonable grounds for suspecting that such an incident has occurred, 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 theRead full regulation →
- 21CFR1002.30§ 1002.30 Records to be maintained by manufacturers.
(a) Manufacturers of products listed under table 1 of § 1002.1 shall establish and maintain the following records with respect to such products:Read full regulation →
- 21CFR1000.3§ 1000.3 Definitions.
As used in this subchapter J:Read full regulation →
- 21CFR1002.11§ 1002.11 Supplemental reports.
Prior to the introduction into commerce of a new or modified model within a model or chassis family of a product listed in table 1 of § 1002.1 for which a report under § 1002.10 is required, each manufacturer shall submit a report with respect to such new or modified model describing any changes in Read full regulation →
- 21CFR1002.40§ 1002.40 Records to be obtained by dealers and distributors.
(a) Dealers and distributors of electronic products for which there are performance standards and for which the retail price is $50 or more shall obtain such information as is necessary to identify and locate first purchasers if the product is subject to this section by virtue of table 1 of § 1002.1Read full regulation →
- 21CFR1002.41§ 1002.41 Disposition of records obtained by dealers and distributors.
(a) Information obtained by dealers and distributors pursuant to § 1002.40 shall immediately be forwarded to the appropriate manufacturer unless:Read full regulation →
Related Warning Letters (1)
- 2025-05-27
CGMP/QSR/Medical Devices/Adulterated
Sedecal S.A.
See Also (8)
- Manufacture and Certification of Laser Kits (Laser Notice 13) (Status: Final)
- Clarification of Radiation Control Regulations for Diagnostic X-Ray Equipment (Part 1 ) (Status: Final)
- Procedures for Field Testing Microwave Ovens (Status: Final)
- Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Quality Control Practices for Compliance with the Federal Laser Performance Standard (Status: Final)
- Exemption from Reporting and Record keeping Requirements for Certain Sunlamp Product Manufacturers (Status: Final)
- Compliance Guide for Laser Products (FDA 86-8260) (Status: Final)
- Exemption from Reporting and Recordkeeping Requirements for Low Power Laser Products (Laser Notice 54): Guidance for Industry and FDA Staff (Status: Final)