January 7, 2013
By Thomas Varricchione, Sr. VP Clinical & Regulatory Affairs
The FDA’s DRAFT Guidance for Industry and Food and Drug Administration Staff was issued for a 90-day comment period on 12/12/12. The guidance is relevant to developers, manufacturers, processors, etc. of medical devices, regardless of whether they are prescription or over-the-counter (OTC) products. The guidance defines home use broadly to mean use anywhere outside of a professional healthcare facility or clinical laboratory, e.g. a home, hotel/motel, office building, airport, train or bus terminal, automobile or any form of public transportation vehicle, etc. In essence, they mean anywhere a healthcare professional is not continually available to use a medical device on you or to assist you in using such a product. FDA belives that home use devices are becoming more prevalent predominantly due to :
Home Use devices present unique risks that are associated with user interaction, use environment and the device itself, and device developers need to address those risks during the product design stage to reduce risk as much as possible. The agency points out that their review of premarket submissions for market clearance or approval will look for evidence that these unique risks were identified and mitigated during development as part of their evaluation of the device’s safety and effectiveness. Not having the evidence will weaken and, perhaps, kill chances for a successful FDA premarket review.
FDA cites the Design Control requirement (21 CFR 820.30) found in its Quality System regulation as the underpinning regulation that medical device developers need to adhere to in order to demonstrate that the product “performs properly according to its intended use and user needs.” Attention to human factors engineering as a complement to design engineering is recommended for developing a safe and easy-to-use user interface design.
FDA also recommends developing a Risk Management Plan as an integral part of the product development process for a medical device. Identifying hazards, estimating risks, incorporating risk mitigations and evaluating their effectiveness are all seen as key activities in designing any medical device, but especially one that is meant for use outside of a professional healthcare faciltiy. They also state their preferred hierarchy for applying mitigations, namely:
The bulk of the draft guidance provides additional information and recommendations about specific aspects of the device’s use environment, its user(s), the device or system itself, the human factors associated with its use, and its labeling. In its 23 pages, the guidance refers to multiple (I lost count) quality system and product safety standards, regulatory guidances, and even information sources provided by the U.S. Centers for Disease Control, Department of Homeland Security and the Transportation Security Administration. Clearly, FDA considers this to be an important topic and one that the medical device industry needs to give proper attention to.