Description
Comments and suggestions may be submitted at any time for Agency consideration to James Cheng, Center for Devices and Radiological Health, 9200 Corporate Boulevard, HFZ-450, 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 James Cheng at 240-276-4000 or e-mail atjames.cheng@fda.hhs.gov.
Scope & Applicability
Product Classes
3including cardiotachometer and rate alarm; The primary device subject to this guidance; Cardiac Monitor Guidance, Version 1.0
The devices that are the subject of this guidance are Class II non-spinal metallic bone screws and washers
Class III subject to the 510(k) or PMA requirements
Stakeholders
8contributed to the development of this guidance document
Based on a template by Sandy Stewart
contributed to the development of this guidance document
contributed to the development of this guidance document
contributed to the development of this guidance document
contributed to the development of this guidance document
Advisory panel (74) for cardiac devices
Entity responsible for submitting NDINs
Regulatory Context
Attributes
3Significant changes to intended use are likely remanufacturing.; The purpose for which the device is used, which must not change.
Guidance discusses LOINC codes for uncleared or unapproved indications.
Categorization (minor, moderate, major) for software risk.
Identified Hazards
Hazards
1risks due to strong emissions from the MR system
Related CFR Sections (4)
- 21CFR870.2300§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a) Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset Read full regulation →
- 21CFR807.87§ 807.87 Information required in a premarket notification submission.
Each premarket notification submission shall contain the following information: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.
See Also (8)
- Policy for Device Software Functions and Mobile Medical Applications: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- 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)