From the Consultant’s Corner Newsletter, March/April 2013
FDA recently released a new draft guidance document with the goal of providing the agency’s current thinking relative to home use devices, whether they are prescription or over-the-counter devices. Although this is a draft guidance and “does not establish legally enforceable responsibilities,” it does make it very clear that the manufacturer should include in any premarket submission—510(k) or PMA—summaries of the specific steps taken to ensure that the device is suitable for home use and to explain how the considerations discussed in this guidance document were implemented. It goes on to say that the recommendations found in the guidance should also be considered when a manufacturer is designing a device that is likely to be used in the home, even if it is not solely for home use. Keep in mind that the definition of home is any place that is outside of a professional healthcare facility or clinical laboratory, so it includes much more then just a personal residence.
In summary, the purpose of the guidance is to minimize risks posed by home use devices so that public health can be improved. Basically this mirrors FDA’s overall mission.
The overall recommendation of the guidance involves reducing or minimizing risk to the greatest extent possible through device design or “designing risk out of the device.” Note that this goal is very reminiscent of the new Annex Z found in EN ISO 14971:2012, in which manufacturers should reduce risk “as low as possible,” which has caused quite a controversy (read Are You Prepared for EN ISO 14971:2012? ). To quote the new draft guidance: “You should strive for the highest level of risk mitigation possible by designing risk out of the system to the greatest extent possible.” This does not say anything about reducing risk “As Low As Reasonably Practicable” (ALARP), as is found in ISO 14971: 2007.
To reduce risks, FDA recommends developing a risk management plan with special attention given to the possible causes of use-related errors and failures of home use devices. To encourage manufacturers to design out risks, FDA cites numerous other guidance documents and international standards that should be reviewed and considered including:
- FDA’s Design Control Guidance for Medical Device Manufacturers;
- ANSI/AAMI HE74-2001, Human Factors Design Process for Medical Devices;
- ANSI/AAMI HE 75:2009, Human Factors Engineering Design of Medical Devices.
For devices containing software, the guidance recommends reviewing:
- IEC 62304, First Edition 2006-05, Medical Device Software-Software lifecycle processes;
- FDA’s General Principles of Software Validation Guidance;
- FDA’s Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
The guidance states that manufacturers should consider risks in the following areas: the environment, user, device or system; human factors; and labeling.
For these considerations, the guidance references IEC 60601-11 Edition 1.0 2010-04, Medical electrical equipment – Part 1-11: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
Other major standards that are referenced include:
- ANSI/AAMI/IEC 62366:2007, Medical devices – Application of usability engineering to medical devices;
- ANSI/AAMI/ES 60601-1:2005, Medical electrical equipment – Part I: General requirements for basic safety and essential performance;
- IEC 60601-1-2 Third edition 2007-03, Medical Electrical Equipment, Part 1-2: General Requirements for Basic Safety and Essential Performance – Collateral Standard: Electromagnetic Compatibility – Requirements and Tests;
- IEC 60601-1-8 Second edition 2006-10, Medical electrical equipment; Part 1-8; General requirements for basic safety and essential performance; Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical system;
- ISO 14971:2007.
FDA also recommends numerous other guidance documents pertaining to human factors, usability, reprocessing, disasters, emergencies, hazardous waste, reuse, labeling and so forth.
As is evident from this long list of standards and guidance documents, this new draft guidance is quite comprehensive requiring…no…suggesting that manufacturers consider and minimize all risks as much as possible. It clearly requests manufacturers to include descriptions of their efforts in premarket submissions for these devices.
The impact of this guidance on home use devices is evident, but it is possible that these requests could be just the beginning for all devices: Are you prepared to begin minimizing risk to the greatest extent possible for all of your devices, whether for home use or not?
Brent Noblitt is a Senior Partner and co-founder of Noblitt & Rueland, a 24 year professional firm providing regulatory and technical consulting and training services to medical device manufacturers around the world. Consulting and training services provided by the firm include medical device FDA and international regulations and include quality system issues and subsystems; as well as, submissions. Noblitt has a MS in Bio-Electrical Engineering from Purdue University as well as a MBA from Pepperdine University. For more information about Noblitt & Rueland, view its listing in the Consultants Directory.