Description
Comments and suggestions may be submitted at any time for Agency consideration to, Robert Phillips, Ph.D., Chief, Conventional and Therapeutic Radiological Devices Branch, HFZ-470, 9200 Corporate BLVD., Rockville, MD 20850. Comments may not be acted upon by the Agency until the document is next revised or updated. For questions regarding the use or interpretation of this guidance contact Andrew Kang, MD at (240) 276-3666 or by e-mail ats.kang@fda.hhs.gov.
Scope & Applicability
Product Classes
10intended to detect 511 keV gamma radiation events
A device intended to detect nuclear radiation in the body using a scintillation camera.
SPECT system equipped with coincidence circuitry
Devices intended to detect radionuclides and produce cross-sectional images
Devices intended to detect nuclear radiation and produce cross-sectional plane images
Imaging system also known as SPECT
PET ANDAs
Type of imaging device covered under the guidance scope
Device classification mentioned regarding novel sterilization methods
SPECT devices intended to detect gamma radiation events and produce tomographic images
Stakeholders
2Entity responsible for submitting applications under section 524B
Individual authorized to determine and document eligibility; Individual who may be consulted regarding plasma dilution situations.
Regulatory Context
Attributes
3Specific compliance requirement for software in devices
Status of CPG Sec. 230.140 as of 7/16/2018
In vitro diagnostic devices of this type are typically considered a moderate level of concern
Identified Hazards
Hazards
2Required software safety documentation
Potential risk associated with the device to be summarized in tabular form; potential hazard associated with the device
Related CFR Sections (5)
- 21CFR807.87§ 807.87 Information required in a premarket notification submission.
Each premarket notification submission shall contain the following information:Read full regulation →
- 21CFR801.109§ 801.109 Prescription devices.
A device which, because of any potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use is not safe except under the supervision of a practitioner licensed by law to direct the use of such device, and hence for which “adequate directions for use” canRead full regulation →
- 21CFR20.61§ 20.61 Trade secrets and commercial or financial information which is privileged or confidential.
(a) A trade secret may consist of any commercially valuable plan, formula, process, or device that is used for the making, preparing, compounding, or processing of trade commodities and that can be said to be the end product of either innovation or substantial effort. There must be a direct relationRead full regulation →
- 21CFR892.1200§ 892.1200 Emission computed tomography system.
(a) Identification. An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may includRead full regulation →
- 21CFR892.1310§ 892.1310 Nuclear tomography system.
(a) Identification. A nuclear tomography system is a device intended to detect nuclear radiation in the body and produce images of a specific cross-sectional plane of the body by blurring or eliminating detail from other planes. This generic type of devices may include signal analysis and display eqRead full regulation →
Related Warning Letters (10)
- 2025-12-09
CGMP/QSR/Medical Devices/Adulterated
Envoy Medical Inc.
- 2025-11-25
CGMP/QSR/Medical Devices/Adulterated
Hong Qiangxing Shenzhen Electronics Limited
- 2025-08-12
CGMP/QSR/Medical Devices/Adulterated
Spectra Therapy, LLC
- 2025-08-05
CGMP/QSR/Medical Devices/Adulterated
Mectronic Medicale S.R.L.
- 2025-06-24
CGMP/QSR/Medical Devices/Adulterated
Aju Pharm Co., Ltd.
- 2025-05-27
CGMP/QSR/Medical Devices/Adulterated
Sedecal S.A.
- 2025-05-20
CGMP/QSR/Medical Devices/Adulterated
NeuroSync, Inc.
- 2025-04-22
Noah Medical Corporation
- 2025-04-08
CGMP/QSR/Medical Devices/Adulterated
EpiCare Acquisitions, LLC
- 2025-03-25
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device
Exer Labs, Inc.
See Also (8)
- Acceptance of Clinical Data to Support Medical Device Applications and Submissions: Frequently Asked Questions: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Review Guidelines for Oxygen Generators and Oxygen Equipment for Emergency Use (Status: Final)
- CPG Sec. 398.450 Applicability of Positive Beam Limitation (PBL) Requirements When PBL is Provided on "Other than Stationary General Purpose" Radiographic System (Status: Final)
- CPG Sec. 300.600 Commercial Distribution with Regard to Premarket Notification (Section 510(k)) (Status: Final)
- CPG Sec. 325.100 Karaya Gum Powder and Related Devices for Use by Ostomates (Status: Final)
- Device Labeling Guidance #G91-1 (Blue Book Memo) (Status: Final)
- CPG Sec. 350.100 Packaging Technologies and Tamper-Resistant Packaging Requirements for Contact Lens Solutions and Tablets (Status: Final)
- Guidance for the Content of Premarket Notifications for Biopsy Devices Used in Gastroenterology and Urology (Status: Final)