Jun 01 2022
For the manufacturers which Develop a new home-use device, we provide this guidance, and it applies to both prescription and over-the-counter(OTC) medical devices, including any class I, II, or III devices intended for home use. Through this, into account and, to the extent possible, reduce or minimize risk to acceptable levels through device design.
For any premarket submission to FDA, you should ensure that the device is suitable for home use and provide in the submission data that demonstrate how you considered and addressed the relevant hazards and risks, such as the ones mentioned in this guidance. This can help FDA determine whether applicable safety and effectiveness requirements have been met.
Following the recommendations in this guide can help you develop a device that is best suited to the home use environment, which should decrease the occurrence of adverse events by minimizing the risks to patient and user safety.
Review this guide for the factors that may be applicable to your device type.
The Quality System Regulation (QS regulation) describes requirements intended to help
ensure that finished medical devices have a reasonable assurance of safety and effectiveness. It requires that you establish and maintain procedures to control the design of
the device to ensure that specified design requirements are met.
This guidance provides technical issues to consider during the design and development of home-use devices.
When establishing design controls for home use devices, you should take into account considerations related to device performance and user needs in the home environment, which are discussed in detail below.
Design Controls, a manufacturer must establish procedures to ensure that device design will translate into a device that performs properly according to its intended use and user needs. [21 CFR 820.30]
Design control requirements of the QS regulation apply to design and development of the device as well as its packaging and labeling (e.g., Instructions for Use), and its cleaning, disinfection, and sterilization procedures.
For more information about creating and implementing design controls, we recommend that you refer to FDA's guidance Design Control Guidance for Medical Device Manufacturers (March 11, 1997).
Also, You should consider developing a risk management plan.
This risk management plan should describe the process for identifying hazards, estimating and evaluating the known risks, controlling the risks, and monitoring the effectiveness of the controls. In your risk analysis, special attention should be paid to the possible causes of use-related errors and failures, as home use devices are exposed to more hazards than are present in professional health care facilities and present a greater potential for harm caused by user error.
Your risk management plan should also include elements to control risk that can enhance the
ease of use for the intended user population based on human factors engineering methods
(see Section VIII). You should first strive for the highest level of risk control possible by
designing risk out of the system to the greatest extent possible. Methods to control risk and to enhance ease of use also include designing the device to reduce or minimize risks,
developing protective measures in the device itself (e.g., an automatic shutoff), or providing
information for safety.
It is important to note that labeling alone generally does not offer sufficient risk control for the home use environment because warning labels, especially lengthy ones, can be ignored by or confusing to the user. Accounting for the considerations described in this document will help mitigate risk and guide device design so that it is appropriate for the intended user and use environment. We recommend that you review ANSI/AAMI/ISO14971:2007/(R) 2010, Medical devices – Application of risk management to medical devices.
Software plays a critical role in the operation of some devices.
For these devices, you should focus on developing device and software architecture and algorithms for performance, error detection, control, and recovery. When developing a home-use device, you should broaden your existing concept development and preliminary testing processes to account for the needs of home users and requirements for straightforward device operation, obvious interface layouts, and appropriate alarm methods.
If software upgrades are required, you should consider how this will be performed in the home environment with the lowest risk to the user and the least burden on you.
For software in general, we recommend that you review :
IEC 62304 First edition 2006-05, Medical device software – Software life cycle processes and the identical standard ANSI/AAMI/IEC 62304:2006.
FDA’s guidance General Principles of Software Validation (January 11, 2002).
FDA’s Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005).
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