The new article addresses the matters related to the labelling requirements to be fulfilled when placing clinical electronic thermometers on the market.
Table of content
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document dedicated to clinical electronic thermometers.
The document provides an overview of the applicable regulatory requirements, as well as additional clarifications and recommendations to be taken into consideration by medical device manufacturers and other parties involved to ensure compliance thereto.
In particular, the document describes the special policy introduced by the FDA earlier in the time of the outbreak of Coronavirus Disease 2019 (COVID-19) and the way it should be implemented after the termination of the respective public health emergency.
At the same time, provisions of the guidance are non-binding in their legal nature, nor are they intended to introduce new rules or impose new obligations.
Moreover, the authority explicitly states that an alternative approach could be applied, provided such an approach is in line with the existing legal framework and has been agreed with the authority in advance.
In particular, the FDA has provided comprehensive guidelines that outline the conditions under which medical devices covered by the scope of the document are
Performance Criteria
The FDA asserts that devices that are manufactured in compliance with 21 CFR Part 820 are likely to be safe. Additionally, devices should either have marketing authorization from specific international regulatory bodies or meet certain performance standards.
These standards include a series of ASTM and ISO specifications for clinical thermometers, which cover various aspects from probe covers to the essential performance of infrared thermometers and electronic devices for intermittent patient temperature determination.
The guidelines also extend to electrical standards that ensure medical electrical equipment meets general safety and essential performance requirements.
This includes provisions for electromagnetic disturbances and the adaptability of medical electrical equipment for home healthcare environments.
The authority further explains that software used in medical devices is expected to adhere to a life cycle process outlined by ANSI/AAMI/IEC, ensuring the software’s reliability and safety throughout its use. Biocompatibility is another crucial aspect covered by the standards, requiring biological evaluation within a risk management framework.
Labeling Requirements
The FDA also emphasizes the importance of clear and comprehensive labelling on medical devices.
Labels should provide detailed information on the device’s indications, functionality, and performance, along with an explicit method for determining temperature and an assessment of potential risks.
Additionally, the labelling must include specific instructions for cleaning and reprocessing to maintain the device’s integrity and safety.
Regulatory Compliance and Cybersecurity
The guidelines also highlight the significance of cybersecurity, especially when modifications to hardware or software are intended to enhance remote monitoring capabilities.
Effective cybersecurity measures are vitally important to ensure the safety and functionality of the device.
Manufacturers are expected to comply with existing FDA policies regarding cybersecurity, which encompass considerations during the design phase and postmarket management.
The FDA has proposed to amend the Quality System regulation to more closely align with the International Standard (ISO) 13485:2016, focusing on quality management systems.
This amendment would bring FDA requirements in line with international standards, ensuring a consistent approach to device safety and effectiveness.
Manufacturers are urged to consult various FDA resources to guide the development and maintenance of cybersecurity controls, including the FDA guidance on cybersecurity considerations for medical device quality systems and the content of premarket submissions.
Conclusion
In summary, the present FDA guidance describes in detail the performance- and labelling-related requirements to be considered and followed for clinical electronic thermometers to be allowed for marketing and use in the country.
The document clarifies the scope of information to be included in labelling to ensure users are duly informed on the risks and precautions, as well as on the way the device operates.
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