Contains Nonbinding Recommendations
Enforcement Policy for Clinical 
Electronic Thermometers
Guidance for Industry and
Food and Drug Administration Staff
Document issued on November 3, 2023.
This document supersedes Enforcement Policy for Clinical Electronic 
Thermometers During the Coronavirus Disease 2019 (COVID-19) Public 
Health Emergency issued in April 2020 and updated in March 2023.
For questions about this document, contact OHT3: Office of GastroRenal, ObGyn, General 
Hospital and Urology Devices/DHT3C: Division of Drug Delivery and General Hospital 
Devices, and Human Factors at (301) 796-7030.
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health Contains Nonbinding Recommendations
Preface
Public Comment
You may submit electronic comments and suggestions at any time for Agency consideration to 
https://www.regulations.gov. Submit written comments to the Dockets Management Staff, Food 
and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD 20852-
1740. Identify all comments with the docket number FDA-2023-N-4372. Comments may not be 
acted upon by the Agency until the document is next revised or updated.
Additional Copies
Additional copies are available from the Internet. You may also send an email request to CDRH-
Guidance@fda.hhs.gov to receive a copy of the guidance. Please include the document number 
GUI00020021 and complete title of the guidance in the request. Contains Nonbinding Recommendations
Table of Contents
  
I.  Introduction .......................................................................................................................... 1
II.  Scope .................................................................................................................................... 3
III.  Policy ................................................................................................................................... 3
A.  Overview ......................................................................................................................... 3
(1)  Clinical Electronic Thermometers without Telethermography or Continuous 
Temperature Measurement Functions .......................................................................... 4
(2)  Clinical Electronic Thermometers with Telethermography or Continuous 
Temperature Measurement Functions .......................................................................... 5
(3)  Disposition of a Device ................................................................................................ 7
B.  Performance and Labeling .............................................................................................. 7
C.  Additional Helpful Resources ......................................................................................... 9 Contains Nonbinding Recommendations
Enforcement Policy for Clinical 
Electronic Thermometers
Guidance for Industry and
Food and Drug Administration Staff
This guidance represents the current thinking of the Food and Drug Administration (FDA or 
Agency) on this topic.  It does not establish any rights for any person and is not binding on 
FDA or the public.  You can use an alternative approach if it satisfies the requirements of the 
applicable statutes and regulations.  To discuss an alternative approach, contact the FDA staff 
or Office responsible for this guidance as listed on the title page. 
I. Introduction 
The Food and Drug Administration (FDA or the Agency) plays a critical role in protecting the 
United States from threats such as emerging infectious diseases, including the Coronavirus 
Disease 2019 (COVID-19) pandemic and public health emergencies (PHEs).
Following the emergence of COVID-19, FDA first issued guidance in April 2020 to provide a 
policy to help expand the availability of clinical electronic thermometers to address the PHE. At 
the time, FDA stated that the policy described in the guidance was intended to remain in effect 
only for the duration of the PHE related to COVID-19 declared by the Secretary of Health and 
Human Services (HHS) in accordance with section 319 of the Public Health Service Act (PHS 
Act). On March 13, 2023, FDA announced in the Federal Register notice Guidance Documents 
Related to Coronavirus Disease 2019 (COVID-19),1 that the guidance document was being 
revised to continue in effect for 180 days after the expiration of the COVID-19 PHE declaration, 
and that, during that time, FDA would intend to further revise this guidance, among others. The 
policies described in this guidance take into account that the April 2020 version of the guidance 
is intended to remain in effect through November 7, 2023, unless superseded by a final guidance 
before that date. 
Clinical electronic thermometers are used to measure and monitor the body temperature of 
patients. These devices are an important screening and diagnostic tool to assist in the 
identification of individuals who have or may have a range of conditions and illnesses, including 
1See Federal Register notice Guidance Documents Related to Coronavirus Disease 2019 (COVID-19) (88 FR 
15417), available at https://www.federalregister.gov/documents/2023/03/13/2023-05094/guidance-documents-
related-to-coronavirus-disease-2019-covid-19(hereinafter referred to as the March 13, 2023, Federal Register 
Notice).
1 Contains Nonbinding Recommendations
those who may be infected with COVID-19.2 FDAs previous policies for clinical electronic 
thermometers were intended to help address urgent public health concerns by helping to expand 
the availability of clinical electronic thermometers during the COVID-19 PHE, thereby helping 
to prevent or mitigate potential shortages as the demand increased due to usage at critical 
locations such as airports, hospitals, and other locations. Since first issuing the guidance 
Enforcement Policy for Clinical Electronic Thermometers During the Coronavirus Disease 
2019 (COVID-19) Public Health Emergency in April 2020, FDAs experience has generally 
demonstrated that the public health equities weigh in favor of continuing certain enforcement 
policies for these devices beyond the expiration of the COVID-19 PHE (which expired on May 
11, 2023) and the 180-day period announced in the March 13, 2023, Federal Register notice. 
More specifically, FDA has evaluated the benefits and risks to patients and healthcare providers 
of maintaining certain enforcement policies, including identifying certain device types for which 
continued enforcement policies might be appropriate, and assessing other lessons learned from 
implementation of COVID-19-related enforcement policies for certain device types. 
During the COVID-19 PHE, FDA issued certain enforcement policies for non-invasive remote 
monitoring devices and clinical electronic thermometers. The policies regarding the modification 
of previously FDA-cleared clinical electronic thermometers within product code FLL were 
originally included in FDAs guidance Enforcement Policy for Non-Invasive Remote 
Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease 2019 
(COVID-19) Public Health Emergency first issued in March 2020, and subsequently revised in 
June 2020, October 2020, and March 2023.3 The policies regarding the distribution and use of 
clinical electronic thermometers not previously cleared under section 510(k) of the Federal Food, 
Drug, and Cosmetic Act (FD&C Act) (510(k)-cleared) were outlined in FDAs guidance 
Enforcement Policy for Clinical Electronic Thermometers During the Coronavirus Disease 
2019 (COVID-19) Public Health Emergency issued in April 2020 and revised in March 2023. 
FDA has revised and consolidated the policies that apply to clinical electronic thermometers in 
this guidance. 
This guidance is being implemented without prior public comment because FDA has determined 
that prior public participation for this guidance is not feasible or appropriate (see section 
701(h)(1)(C) of the FD&C Act and 21 CFR 10.115(g)(2)). FDA has determined that this 
guidance document presents a less burdensome policy that is consistent with public health. This 
guidance document is being implemented immediately, but it remains subject to comment in 
accordance with the Agencys good guidance practices.
In general, FDAs guidance documents do not establish legally enforceable responsibilities. 
Instead, guidances describe the Agencys current thinking on a topic and should be viewed only 
as recommendations, unless specific regulatory or statutory requirements are cited. The use of 
2Fever is a common symptom of COVID-19, typically appearing 2-14 days after exposure. 
https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html
3See FDAs guidance Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient 
Monitoring issued on October 19, 2023, available at https://www.fda.gov/regulatory-information/search-fda-
guidance-documents/enforcement-policy-non-invasive-remote-monitoring-devices-used-support-patient-monitoring. 
Product code FLL is not within the scope of that guidance.
2 Contains Nonbinding Recommendations
the word should in Agency guidances means that something is suggested or recommended, but 
not required.
II. Scope
The enforcement policies in this guidance apply to clinical electronic thermometers, which are 
regulated as Class II devices under 21 CFR 880.2910, product code FLL. These devices include 
both contact and non-contact clinical electronic thermometers.
III. Policy
A. Overview
Manufacturers of clinical electronic thermometers are required to submit a premarket notification 
under section 510(k) of the FD&C Act to FDA and receive FDA clearance prior to marketing 
these devices in the United States, as well as comply with post-marketing and other 
requirements.  Based on our experience during the COVID-19 pandemic and other available 
information, in conjunction with the issuance of this guidance, FDA is proposing to exempt 
certain clinical electronic thermometersspecifically clinical thermometers without 
telethermography or continuous temperature measurement functionsfrom premarket 
notification requirements under section 510(m) of the FD&C Act.4 At this time, FDA does not 
propose exempting these devices from other statutory and regulatory requirements. As such, the 
sections below (organized by clinical thermometer type) describe enforcement policies that are 
intended to help foster compliance with certain applicable legal requirements for these devices.  
FDA intends to withdraw this guidance after any final exemption notice has been published in 
the Federal Register.
To address any unique considerations or other issues not otherwise discussed in this guidance, 
manufacturers may wish to initiate discussions with the Agency through the Q-Submission 
Program.5  
As always, FDA will make case-by-case decisions regarding the enforcement of legal 
requirements in response to particular circumstances and questions that arise regarding a specific 
device or device type.
4 See Federal Register notice "Medical Devices; Exemptions from Premarket Notification: Class II Devices; Clinical 
Electronic Thermometers; Request for Comments" (88 FR 75602), available at https://www.federalregister.gov/
d/2023-24290
5 See FDAs guidance, Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission 
Program, available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/requests-
feedback-and-meetings-medical-device-submissions-q-submission-program. 
3 Contains Nonbinding Recommendations
(1) Clinical Electronic Thermometers without Telethermography
or Continuous Temperature Measurement Functions
a. Devices that were previously 510(k)-cleared
At this time, for clinical electronic thermometers without telethermography or continuous 
temperature measurement functions that were previously 510(k)-cleared, FDA does not intend to 
object to the distribution and use of such devices where they have undergone limited 
modifications to the indications, functionality, or hardware or software without prior submission 
of a premarket notification under section 510(k) of the FD&C Act,6 where such submission 
would be required7 and where the modifications do not create an undue risk. Similar to the 
previous policies for these devices, this enforcement policy does not apply to all other statutory 
and regulatory requirements. 
Examples of such modifications that FDA generally believes do not create an undue risk include:
 For devices previously marketed only for use in hospitals or other healthcare facilities, a
change to the indications regarding use in the home setting; and
 Hardware or software changes to allow for increased remote monitoring capability.
FDA believes such devices generally will not create such an undue risk where the device 
incorporates certain performance and labeling elements, such as those described in Section III.B.
b. Devices that were not previously 510(k)-cleared
For clinical electronic thermometers without telethermography or continuous temperature 
measurement functions that were not previously 510(k)-cleared, FDA does not intend to object to 
the distribution and use of such devices without prior submission of a 510(k) where such device 
does not create an undue risk. FDA believes such devices generally will not create such an undue 
risk where the device incorporates certain performance and labeling elements, such as those 
described in Section III.B.8
Further, for such devices that are already distributed by the date of issuance of this guidance, 
FDA does not intend to object to such devices not complying with reports of corrections and 
removals requirements (see 21 CFR Part 806), registration and listing requirements (see 21 CFR 
Part 807), and Unique Device Identification (UDI) requirements (see 21 CFR Part 801 Subpart B 
6As discussed above, in conjunction with the issuance of this guidance, FDA is proposing to exempt clinical 
electronic thermometers without telethermography or continuous temperature measurement functions from 
premarket notification requirements under section 510(m) of the FD&C Act. FDA intends to withdraw this guidance 
after any final exemption notice has been published in the Federal Register.
7See 21 CFR 807.81. For further guidance on modifications that trigger the requirement that a manufacturer submit 
a new 510(k) to FDA, refer to the FDA guidances Deciding When to Submit a 510(k) for a Change to an Existing 
Device, available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/deciding-when-
submit-510k-change-existing-deviceand Deciding When to Submit a 510(k) for a Software Change to an Existing 
Device, available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/deciding-when-
submit-510k-software-change-existing-device.
8As discussed above, in conjunction with the issuance of this guidance, FDA is proposing to exempt clinical 
electronic thermometers without telethermography or continuous temperature measurement functions from 
premarket notification requirements under section 510(m) of the FD&C Act. FDA intends to withdraw this guidance 
after any final exemption notice has been published in the Federal Register.
4 Contains Nonbinding Recommendations
and Part 830) for 180 days from the date of issuance of this guidance. FDA believes that this 
180-day transition period, following the issuance of this guidance, will help foster compliance 
with certain applicable legal requirements, which were also included in FDAs previous 
enforcement policies for these devices. By the end of the 180-day transition period, if not already 
doing so, manufacturers of clinical electronic thermometers without telethermography or 
continuous temperature measurement functions that were not previously 510(k)-cleared are 
expected to follow these requirements. This aspect of the policy does not apply after the 180-day 
transition period ends and does not apply to devices that were not distributed prior to the 
issuance date of this guidance. 
(2) Clinical Electronic Thermometers with Telethermography or 
Continuous Temperature Measurement Functions  
a.  Devices that were previously 510(k)-cleared 
For clinical electronic thermometers with telethermography or continuous temperature 
measurement functions that are already distributed by the date of issuance of this guidance and 
were previously 510(k)-cleared, and for which limited modifications to the indications, 
functionality, or hardware or software were made to allow use in the home setting or for 
increased remote monitoring capability, FDA does not intend to object to continued distribution 
and use of such devices without prior submission of a 510(k) where (1) a required premarket 
notification9 has been submitted to and accepted by FDA within 180 days from the date of 
issuance of this guidance, (2) FDA has not taken a final action10 on the premarket notification, 
and (3) such devices will not create an undue risk. FDA believes such devices generally will not 
create such an undue risk where the device incorporates certain performance and labeling 
elements, such as those described in Section III.B.
In addition, for these same devices, during this 180-day transition period and while the device is 
under FDA review, FDA does not intend to object to the devices not complying with certain UDI 
requirements (see 21 CFR Part 801 Subpart B) and other applicable labeling requirements (see 
21 CFR Part 801). This enforcement policy does not apply to all other statutory and regulatory 
requirements. This enforcement policy also does not apply after FDA has taken a final action on 
the premarket notification for a device.
Once FDA has taken a final action, FDA expects manufacturers to comply with all applicable 
legal requirements for the device/manufacturer. Following the devices marketing authorization, 
9See 21 CFR 807.81. For further guidance on modifications that trigger the requirement that a manufacturer submit 
a new 510(k) to FDA, refer to the FDA guidances Deciding When to Submit a 510(k) for a Change to an Existing 
Device, available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/deciding-when-
submit-510k-change-existing-deviceand Deciding When to Submit a 510(k) for a Software Change to an Existing 
Device, available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/deciding-when-
submit-510k-software-change-existing-device.
10For purposes of this guidance, FDA uses the term final action to mean a Medical Device User Fee Amendments 
(MDUFA) decision, which can include positive decisions, negative decisions, and notices of withdrawals, consistent 
with the guidance FDA and Industry Actions on Premarket Notification (510(k)) Submissions: Effect on FDA 
Review Clock and Goals, available at https://www.fda.gov/regulatory-information/search-fda-guidance-
documents/fda-and-industry-actions-premarket-notification-510k-submissions-effect-fda-review-clock-and-goals.
5 Contains Nonbinding Recommendations
this includes labeling updates (see 21 CFR Part 801), compliance with UDI requirements (see 21 
CFR Part 801 Subpart B and Part 830), and any applicable updates to registration and listing 
information, including the submission number (see 21 CFR Part 807 Subparts B-D).
For modified devices under this policy, that are subject to a premarket notification under section 
510(k) of the FD&C Act, any required premarket notification is expected to be submitted to and 
accepted by FDA by the end of the 180-day transition period if the manufacturer intends to 
continue distribution of the device. FDA believes that a 180-day transition period following 
issuance of this guidance will help foster compliance with certain applicable legal requirements, 
including premarket notification requirements.
b. Devices that were not previously 510(k)-cleared 
For clinical electronic thermometers with telethermography or continuous temperature 
measurement functions that are already distributed by the date of issuance of this guidance and 
were not previously 510(k)-cleared, FDA does not intend to object to continued distribution and 
use of such devices without prior submission of a 510(k) where (1) a required premarket 
notification has been submitted to and accepted by FDA within 180 days from the date of 
issuance of this guidance, (2) FDA has not taken a final action11 on the premarket notification, 
and (3) such devices will not create an undue risk. FDA believes such devices generally will not 
create such an undue risk where the device incorporates certain performance and labeling 
elements, such as those described in Section III.B. 
Further, for these same devices, during the 180-day transition period and while the device is 
under FDA review, FDA does not intend to object to such devices not complying with reports of 
corrections and removals requirements (see 21 CFR Part 806), registration and listing 
requirements (see 21 CFR Part 807), UDI requirements (see 21 CFR Part 801 Subpart B and Part 
830), and other applicable labeling requirements (see 21 CFR Part 801). This enforcement policy 
does not apply to devices that were not distributed prior to the issuance date of this guidance or 
after FDA has taken a final action on the premarket notification for a device.
Once FDA has taken a final action, FDA expects manufacturers to comply with all applicable 
legal requirements for the device/manufacturer. Following the devices marketing authorization, 
this includes labeling updates (see 21 CFR Part 801), compliance with UDI requirements (see 21 
CFR Part 801 Subpart B and Part 830), and any applicable updates to registration and listing 
information, including the submission number (see 21 CFR Part 807 Subparts B-D).
For devices under this policy, any required premarket notification is expected to be submitted to 
and accepted by FDA by the end of the 180-day transition period if the manufacturer intends to 
continue distribution of the device. FDA believes that a 180-day transition period following 
issuance of this guidance will help foster compliance with certain applicable legal requirements, 
including premarket notification requirements.
11For purposes of this guidance, FDA uses the term final action to mean a Medical Device User Fee Amendments 
(MDUFA) decision, which can include positive decisions, negative decisions, and notices of withdrawals, consistent 
with the guidance FDA and Industry Actions on Premarket Notification (510(k)) Submissions: Effect on FDA 
Review Clock and Goals, available at https://www.fda.gov/regulatory-information/search-fda-guidance-
documents/fda-and-industry-actions-premarket-notification-510k-submissions-effect-fda-review-clock-and-goals.
6 Contains Nonbinding Recommendations
(3) Disposition of a Device 
For manufacturers of devices that intend to discontinue distribution of a device within the scope 
of this guidance or voluntarily withdraw such devices from the market after the 180-day 
transition period, as applicable, FDA strongly encourages manufacturers to engage with the 
Agency if they have questions specific to their situation. To address any unique considerations or 
other extenuating circumstances, including disposition and use of already distributed12 devices, 
not otherwise discussed in this guidance, manufacturers may engage in discussions with the 
Agency through the Q-Submission Program.13
B. Performance and Labeling 
As discussed above, FDA believes these devices generally will not create an undue risk where 
the device incorporates certain performance and labeling elements, such as the following: 
1) The device is manufactured consistent with 21 CFR Part 820;14
2) The device has marketing authorization through a premarket notification or in one of the 
following regulatory jurisdictions: European CE Mark, Australian Register of 
Therapeutic Goods Certificate of Inclusion, Health Canada License, or Ninsho 
certification in Japan, or the performance of the device conforms to the following 
standards, as applicable:  
 Thermometer Standards
 ASTM E1104 Standard Specification for Clinical Thermometer Probe Covers 
and Sheaths
 ASTM E1965 Standard Specification for Infrared Thermometers for Intermittent 
12For purposes of this guidance, devices are considered to be already distributed if they are finished devices (21 
CFR 820.3(l)) that are labeled and are in distribution (21 CFR 807.3(b)) in the U.S. supply chain or are in the 
possession of the end user. For purposes of this guidance, FDA would generally consider devices to be in 
distribution to mean those finished, labeled devices that are no longer in the manufacturers possession that are in 
transit to or held in a third partys device inventory not on behalf of the manufacturer, in a federal, state, or other 
government stockpile, or at a location where devices are then offered for direct sale to the end user.
13See FDAs guidance, Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission 
Program, available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/requests-
feedback-and-meetings-medical-device-submissions-q-submission-program. 
14On February 23, 2022, FDA proposed to amend the device Quality System regulation, 21 CFR part 820, to align 
more closely with international consensus standards for devices (87 FR 10119; available at 
https://www.federalregister.gov/ 
documents/2022/02/23/2022-03227/medical-devices-quality-system-regulation-amendments). Specifically, FDA 
proposed to withdraw the majority of the current requirements in part 820 and instead incorporate by reference the 
2016 edition of the International Organization for Standardization (ISO) 13485, Medical devices - Quality 
management systems for regulatory purposes, in part 820. As stated in that proposed rule, the requirements in ISO 
13485 are, when taken in totality, substantially similar to the requirements of the current part 820, providing a 
similar level of assurance in a firms quality management system and ability to consistently manufacture devices 
that are safe and effective and otherwise in compliance with the FD&C Act. FDA intends to finalize this proposed 
rule expeditiously. When a final rule takes effect, FDA also intends to update the references to provisions in 21 CFR 
part 820 in this guidance to be consistent with that rule.
7 Contains Nonbinding Recommendations
Determination of Patient Temperature
 ASTM E1112 Standard Specification for Electronic Thermometer for Intermittent 
Determination of Patient Temperature
 ISO 80601-2-56 Medical electrical equipment - Part 2-56: Particular 
requirements for basic safety and essential performance of clinical thermometers 
for body temperature measurement
 Electrical Standards 
 ANSI/AAMI ES60601-1 Medical electrical equipment - Part 1: General 
requirements for basic safety and essential performance
 ANSI/AAMI/IEC 60601-1-2 Medical electrical equipment  Part 1-2: General 
requirements for basic safety and essential performance  Collateral Standard: 
Electromagnetic disturbances  Requirements and tests 
 ANSI/AAMI/IEC 60601-1-11 Medical electrical equipment  Part 1-11: General 
requirements for basic safety and essential performance  Collateral Standard: 
Requirements for medical electrical equipment and medical electrical equipment 
and medical electrical systems used in the home healthcare environment
 Software Standards 
 ANSI/AAMI/IEC 62304 Medical device software - Software life cycle processes 
 Biocompatibility Standards
 ANSI/AAMI/ISO 10993-1 Biological evaluation of medical devices - Part 1: 
Evaluation and testing within a risk management process 
 
For the current edition of the FDA-recognized consensus standard(s) referenced in this 
document, see the FDA Recognized Consensus Standards Database.15 For more 
information regarding use of consensus standards in regulatory submissions, refer to FDA 
guidance titled Appropriate Use of Voluntary Consensus Standards in Premarket 
Submissions for Medical Devices.16
3) The device labeling includes a clear description of the available data on the devices 
indications or functions including:
a. device performance;
b. method of determining temperature;
c. potential risks; and
d. cleaning and reprocessing instructions.
In addition, modifications to hardware or software intended to increase remote monitoring 
capability may impact cybersecurity risks. Effective cybersecurity is necessary to ensure device 
safety and functionality. Manufacturers must meet cybersecurity requirements and should refer 
15https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm
16https://www.fda.gov/regulatory-information/search-fda-guidance-documents/appropriate-use-voluntary-
consensus-standards-premarket-submissions-medical-devices 
8 Contains Nonbinding Recommendations
to FDAs existing policies applicable to their devices. The following online resources may be 
helpful in developing and maintaining these cybersecurity controls: 
 Cybersecurity in Medical Devices: Quality System Considerations and Content of 
Premarket Submissions  Guidance for Industry and Food and Drug Administration 
Staff;17
 Postmarket Management of Cybersecurity in Medical Devices Guidance for 
Industry and Food and Drug Administration Staff;18 and
 FDA Fact Sheet: The FDAs Role in Medical Device Cybersecurity - Dispelling 
Myths and Understanding Facts.19
C.  Additional Helpful Resources
The following online resources may also be helpful in evaluating the performance of the device: 
 Guidance on the Content of Premarket Notification [510(K)] Submissions for Clinical 
Electronic Thermometers 20
 Radio Frequency Wireless Technology in Medical Devices - Guidance for Industry and 
FDA Staff 21
 Content of Premarket Submissions for Device Software Functions - Guidance for 
Industry and Food and Drug Administration Staff 22
 Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling
 Guidance for Industry and Food and Drug Administration Staff23
 Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - 
Part 1: Evaluation and testing within a risk management process"  Guidance for Industry 
and Food and Drug Administration Staff24
17https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cybersecurity-medical-devices-
quality-system-considerations-and-content-premarket-submissions
18https://www.fda.gov/regulatory-information/search-fda-guidance-documents/postmarket-management-
cybersecurity-medical-devices
19https://www.fda.gov/media/123052/download
20https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-content-premarket-
notification-510k-submissions-clinical-electronic-thermometers
21https://www.fda.gov/regulatory-information/search-fda-guidance-documents/radio-frequency-wireless-
technology-medical-devices-guidance-industry-and-fda-staff
22https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-content-premarket-
submissions-software-contained-medical-devices
23https://www.fda.gov/regulatory-information/search-fda-guidance-documents/reprocessing-medical-devices-
health-care-settings-validation-methods-and-labeling
24https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-international-standard-iso-
10993-1-biological-evaluation-medical-devices-part-1-evaluation-and
9