The new article provides a detailed overview of the regulatory requirements related to postmarket considerations 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 dedicated to medical devices intended for home use. In particular, the guidance provides additional clarifications regarding the applicable regulatory requirements, as well as recommendations to be considered by medical device manufacturers and other parties involved to achieve and sustain compliance thereto. At the same time, provisions of the guidance are non-binding, nor are intended to introduce new rules or impose new requirements. Moreover, an alternative approach could be applied, provided such an approach is in line with the existing legislation and has been agreed with the authority in advance.
The scope of the guidance covers various aspects to be considered concerning home-use medical devices including, inter alia, the ones related to postmarket consideration. The authority emphasizes the specific nature of risks associated with the use of the products described in the guidance since they are intended to be used outside the clinical environment by persons having no special knowledge or experience, hence, the risks arising could be different from the ones that are common for general medical devices. Consequently, the regulatory approach to be applied should be different as well.
First of all, the party responsible for a medical device intended to be marketed and used in the US should take all the necessary measures to ensure the customers have access to technical assistance they may reasonably need when using the device for its intended purposes. This includes, inter alia, the assistance provided via phone, email, or online in any other form. The authority additionally emphasizes that in the case of life-supporting or life-sustaining medical devices such assistance should be available 24 hours a day. Furthermore, it is stated that all the data collected in the course of provisions of such assistance should be subject to a rigorous assessment, as it constitutes a valuable source of information regarding the actual safety and performance of a medical device.
Medical Device Reporting
Under the general rule set forth by the Medical Device Reporting (MDR) regulation, a party responsible for a medical device should submit a report to the FDA whenever it becomes aware of information that reasonably suggests that a device marketed may have caused or contributed to a reportable serious injury, or has malfunctioned and the malfunction would be likely to cause or contribute to a reportable serious injury should it recur. The document further provides references to the respective manual containing detailed instructions to be followed by the party responsible for a medical device when preparing and submitting a report on the adverse event on the device in question. Apart from this, the authority also refers to the respective guidelines on reporting, which describe the particular way it should be undertaken.
According to the guidance, the aspects to be considered concerning a medical device intended for home use should include, inter alia, the following ones:
- Physical environment;
- Intended users;
- User interface (including the device design);
- Labeling and instructions for use;
- Human factors.
The above factors are to be taken into consideration to ensure the overall safety and effectiveness of home-use medical devices.
Moreover, medical device manufacturers are encouraged to provide a detailed description of the activities undertaken when assessing the potential impact of the abovementioned factors, and also the measures implemented to address the risks identified, as this will be beneficial in terms of demonstrating compliance with the applicable safety- and performance-related requirements. All these factors should be considered from the early design and development stage to ensure that the device will be used safely and efficiently, and also mitigate the risks associated thereto.
The guidance also provides a list of standards to be applied concerning home-use medical devices and various aspects to be considered in this regard. These standards include, inter alia, the following ones:
- ANSI/AAMI/ISO 14971:2007/(R)2010, Medical devices – Application of risk management to medical devices.
- IEC 62304 First edition 2006-05, Medical device software – Software life cycle processes and the identical standard ANSI/AAMI/IEC 62304:2006.
- ASTM D4169-09, Standard practice for performance testing of shipping containers and systems.
- ANSI/AAMI ES60601-1:2012 (Edition 3.1), Medical electrical equipment – Part I: General requirements for basic safety and essential performance.
- ANSI/AAMI HE75:2009, Human factors engineering – Design of medical devices.
In summary, the present FDA guidance highlights the key points to be taken into consideration concerning postmarket surveillance for medical devices intended for home use. The document describes in detail the approach to be applied by medical device manufacturers and other parties involved in operations with home-use products in terms of assistance to customers and reporting adverse events associated with the products they are responsible for.
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