Description
This guidance was written prior to the February 27, 1997 implementation of FDA’s Good Guidance Practices, GGP’s. It does not create or confer rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulations, or both. This guidance will be updated in the next revision to include the standard elements of GGP’s.
Scope & Applicability
Product Classes
4software controlled electronic thermometers requiring level of concern indication
Guidance for the Content of Premarket Notifications for Conventional and Antimicrobial Foley Catheters
A device used to measure the body temperature of a patient by means of a transducer
The devices that are the subject of this guidance are Class II non-spinal metallic bone screws and washers
Stakeholders
4Entity required to conduct postmarket surveillance; entity responsible for submitting postmarket surveillance plans; Entity holding the approved PMA, HDE, or cleared 510(k); The entity responsible for conducting postmarket surveillance and submitting reports.; Entity that can use the checklist as a reference for submissions.
Person responsible for establishing FSVP; Person in the United States who owns or has purchased the food at time of entry; entity responsible for FSVP compliance; Entity responsible for FSVP compliance; Entity responsible for conducting hazard analysis; Subject of FSVP requirements for food for humans and animals.; The entity responsible for FSVP compliance and supplier approval.; entity responsible for foreign supplier verification; entity responsible for developing FSVP; entity responsible for
Entity involved in investigational drug supply chain
entity submitting marketing applications
Regulatory Context
Attributes
5Performance characteristic assessed via linearity experiment
mathematical equations used to derive the estimates
Evidence of a new intended use based on communications
Categorization (minor, moderate, major) for software risk.
Closeness of agreement between a series of measurements from multiple samplings.; Performance characteristic measured by intermediate precision; Performance characteristic to be validated
Related CFR Sections (5)
- 21CFR880.2900§ 880.2900 Clinical color change thermometer.
(a) Identification. A clinical color change thermometer is a disposable device used to measure a patient's oral, rectal, or axillary (armpit) body temperature. The device records body temperature by use of heat sensitive chemicals which are sealed at the end of a plastic or metal strip. Body heat caRead full regulation →
- 21CFR880.2920§ 880.2920 Clinical mercury thermometer.
(a) Identification. A clinical mercury thermometer is a device used to measure oral, rectal, or axillary (armpit) body temperature using the thermal expansion of mercury.Read full regulation →
- 21CFR880.2910§ 880.2910 Clinical electronic thermometer.
(a) Identification. A clinical electronic thermometer is a device used to measure the body temperature of a patient by means of a transducer coupled with an electronic signal amplification, conditioning, and display unit. The transducer may be in a detachable probe with or without a disposable coverRead full regulation →
- 21CFR801.4§ 801.4 Meaning of intended uses.
The words intended uses or words of similar import in §§ 801.5 , 801.119 , 801.122 , and 1100.5 of this chapter refer to the objective intent of the persons legally responsible for the labeling of an article (or their representatives). The intent may be shown by such persons' expressions, the designRead 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 →
Related Warning Letters (2)
- 2025-07-15
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA)
WHOOP, Inc.
- 2023-11-14
CGMP/QSR/Medical Devices/Misbranded
Wello Inc.
See Also (8)
- Guidance on the Content of Premarket Notification [510(K)] Submissions for Clinical Electronic Thermometers (Status: Final)
- Guidance for the Content of Premarket Notifications for Biopsy Devices Used in Gastroenterology and Urology (Status: Final)
- Content of Premarket Submissions for Device Software Functions: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- How to Prepare a Pre-Request for Designation (Pre-RFD): Guidance for Industry (Status: Final)
- Computer Software Assurance for Production and Quality System Software: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products: Draft Guidance for Industry and Other Interested Parties (Status: Draft)
- Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers (Status: Final)
- Remanufacturing of Medical Devices: Guidance for Industry, Entities That Perform Servicing or Remanufacturing, and Food and Drug Administration Staff (Status: Final)