The article provides an overview of the regulatory requirements for home use products.
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document describing design considerations for devices intended for home use. The document is intended to provide additional clarifications regarding the applicable regulatory requirements, as well as recommendations to be considered by medical device manufacturers and other parties involved to ensure compliance thereto. At the same time, provisions of the guidance are non-binding and are not intended to introduce new rules or impose new requirements. Moreover, the authority explicitly states that an alternative approach could be applied, provided such an approach is in line with the provisions of existing legislation and has been agreed with the authority in advance.
The present guidance document is intended to assist medical device manufacturers in ensuring their products comply with the regulatory requirements on safety and effectiveness to be applied concerning medical devices intended for home use. The authority acknowledges that due to the specifics of home use and factors associated thereto, such devices are associated with unique risks related to the interactions among the device, the use environment, and the end-user, who is a layperson without a proper background in healthcare or the appropriate qualification. For this purpose, the document highlights the most important aspects to be considered by medical device manufacturers at the device design and development stage and also describes the approach to be followed to minimize such risks.
The document also contains references to the FDA-recognized voluntary consensus standards medical device manufacturers may use to demonstrate compliance with the applicable regulatory requirements and respective principles.
The authority further states that the use of medical devices at home increases significantly nowadays. This takes place due to the increasing need for medical devices used by patients with chronic diseases. At the same time, wider use of medical devices at home allows reducing significantly the burden the healthcare system faces, as well as the costs associated with providing care to the patients that need it. The wider use of medical devices outside of healthcare facilities allows to improve the quality of life, but at the same time creates additional risks, mostly associated with the use of a device by a person who is not a healthcare professional, hence, has no proper qualification or knowledge. This results in an increased risk related to potential misuse of the device, which can adversely impact the safety of patients.
Based on the above mentioned aspects, the FDA has developed specific recommendations to be considered by medical device manufacturers when developing their products to ensure their safety and effectiveness, as well as public health protection. As explained by the authority, it is always easier to address the risks in the early design and development stage – in this case, it will require less effort and expenses. At the same time, failure to adequately consider potentially hazardous situations during the design of home-use devices may result in inappropriate use, use error, or incompatibilities between the use environment, the user, and the device, which could potentially result in severe adverse consequences.
Hence, when developing a new medical device intended for home use, a manufacturer should duly consider the recommendations provided in this guide to reduce the risks associated with this device to an acceptable level. In this respect, the authority refers to “designing risk out of the device”. Before applying for marketing approval, the manufacturer should ensure the product could be used in the home environment by laypersons safely and efficiently, and also demonstrate that all the risks and hazards have been duly assessed. Using the information provided, the authority will determine whether the product subject to review complies with the applicable regulatory requirements.
Recommendations provided in the present guidelines are intended to assist medical device manufacturers in developing devices that will be suitable for home use, and also to minimize the risks associated with such use.
Scope and Definitions
As it is stated by the FDA, the scope of the document covers any medical devices (including both prescription and over-the-counter (OTC) ones) intended for home use. The document provides recommendations to be considered during the initial design and development stage, as well as concerning post market activities. Furthermore, the authority mentions that the recommendations should be considered even if the device is not intended solely for home use, but the manufacturer reasonably assumes it could be used outside the clinical environment. Hence, the manufacturers are encouraged to study the guide carefully and follow the recommendations that apply to the devices they are responsible for.
To assist medical device manufacturers and other parties involved in interpreting provisions of the applicable regulations, as well as recommendations contained in the guidance, the authority also provides definitions of the most important terms and concepts used in the context of medical devices intended for home use including, inter alia, the following ones:
- A home use device is a medical device labeled for use in any environment outside a professional healthcare facility. As further explained by the FDA, this concept covers various environments, including vehicles or emergency shelters. It is also important to mention that this concept also covers the products that are intended to be used in both healthcare facilities and outside.
- A user stands for a layperson such as a patient (care recipient), caregiver, or family member who directly operates or handles a device or provides assistance to the patient using the device.
- A qualified healthcare professional is a licensed or non-licensed healthcare professional with sufficient skills and experience with the use of a device to aid or train someone to use and maintain the device.
Apart from the ones listed above, the document provides definitions of such terms as “lay”, “professional healthcare facility”, and “clinical laboratory”.
In summary, the present FDA guidance provides an overview of the applicable regulatory requirements for medical devices intended for home use. The document clarifies the regulatory status of such products and explains the way to be followed to determine whether the product in question should be considered as intended for home use.
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