Description
Comments and suggestions may be submitted at any time for Agency consideration to Robert Phillips, Ph.D., Radiological Devices Branch, Division of Reproductive; Abdominal; Ear, Nose, and Throat; and Radiological Devices. 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 Robert Phillips, Ph.D., at (301) 796-2787 or by e-mail atRobertA.Phillips@fda.hhs.gov.
Scope & Applicability
Product Classes
3A radiation detection device intended to assay radionuclides before their administration to patients.
Devices subject to section 522 postmarket surveillance orders; devices subject to postmarket surveillance orders
The primary device category addressed by this guidance.
Stakeholders
4Entity responsible for submitting applications under section 524B
Individual required to sign the truthful and accurate statement
Organization employed to determine conformance with standards
accredited under TPP to issue facility certifications
Regulatory Context
Attributes
1Standard for 510(k) clearance
Identified Hazards
Hazards
1risks due to strong emissions from the MR system
Related CFR Sections (6)
- 21CFR807.87§ 807.87 Information required in a premarket notification submission.
Each premarket notification submission shall contain the following information:Read full regulation →
- 21CFR892.1360§ 892.1360 Radionuclide dose calibrator.
(a) Identification. A radionuclide dose calibrator is a radiation detection device intended to assay radionuclides before their administration to patients.Read full regulation →
- 21CFR807.92§ 807.92 Content and format of a 510(k) summary.
(a) A 510(k) summary shall be in sufficient detail to provide an understanding of the basis for a determination of substantial equivalence. FDA will accept summaries as well as amendments thereto until such time as FDA issues a determination of substantial equivalence. All 510(k) summaries shall conRead full regulation →
- 21CFR807.93§ 807.93 Content and format of a 510(k) statement.
- 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 →
- 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 →
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)