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10 Things You need to know about Human Factors Validation

10 Things You need to know about Human Factors Validation

As medical devices become more complex, the FDA will continue to place greater emphasis on ways to improve safety and effectiveness before products are commercialized. One relatively recent method is Human Factors Engineering, also known as Usability Engineering, which is used to identify and mitigate use errors. Of course, this can place additional burdens on manufacturers to justify that their device has accounted for as many of these potential risks as possible. The list below, which is by no means exhaustive, is intended to point you in the right direction as you prepare for meeting FDA requirements for Human Factors Validation Testing. Human Factors should be considered throughout the design and development process, not just when you’re ready to go to market. Formative evaluations, such as focus groups and expert interviews, can and should be conducted throughout the design and development process. These studies usually consist of 5-8 people and can be conducted somewhat informally. Valuable information can be gleaned from formative evaluations, such as design improvements and identification of potential use errors that could be mitigated by making adjustments to the device interface. Additionally, the FDA and other notified bodies often want to see how your design has been influenced based on the results of these studies. Summative evaluations are the formal validation studies conducted for the final version of the device. These studies are your Human Factors Validation Testing that must follow the requirements of the FDA guidance, Applying Human Factors and Usability Engineering to Medical Devices, and the EU standard, IEC 62366-1: Medical devices – Part 1: Application of usability engineering to medical devices. These studies...
Software and the FDA Refuse to Accept Policy for 510(k)s 2015 Guidance

Software and the FDA Refuse to Accept Policy for 510(k)s 2015 Guidance

The path to medical device commercialization requires FDA clearance, which most often means filing a pre-marketing notification, also known as a 510(k). The FDA has specific criteria for accepting a 510(k), and they just released their new acceptance policy. This new standard, which will be effective October 1, 2015, replaces the old FDA Refuse to Accept Policy for 510(k) Guidance of 2012. The purpose of this Refuse to Accept Guidance is to explain the FDA’s procedures and criteria in assessing whether a 510(k) submission meets a minimum threshold of acceptability and should be accepted for further review. Using the pre-market notification, or 510(k) process, the FDA evaluates whether or not the submission demonstrates substantial equivalence to a predicate device and that the device is as safe and effective as its predicate. Interestingly, the old 2012 Guidance mentions “software” only 18 times. The new 2015 Guidance uses the word “software” 33 times. Additionally, the new Guidance is more specific about the acceptance criteria around software. There is now an entire section (section H) dedicated specifically to device software. This section covers: Whether the device includes software or firmware Whether the device requires software or firmware The level of concern created by the software Software documentation based on the level of concern as described in Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices In only 3 years’ time, the new Guidance has dramatically increased its focus on software, indicating the FDA’s growing concerns around medical device software. As the FDA gets a handle on software-dependent medical devices, manufacturers will be faced with a quality framework that...
Don’t Forget Safety Testing and the Value of Risk Management!

Don’t Forget Safety Testing and the Value of Risk Management!

Establish the Safety of Your Medical Device with IEC 60601 Compliance In our experience, the most frequently forgotten aspect of medical device development and commercialization from emerging companies is establishing a safety profile of a product. While clinical data or clinical trials may be necessary for establishing safety for some products, many Class II devices that follow a 510(k) clearance pathway require minimal, if any, clinical data to support safety claims. Once the need for clinical data is either planned for or eliminated, establishing the safety of a medical device through additional testing tends to be less of a priority. Depending on the technology incorporated into your medical device, applicable safety standards need to be identified during the design stages of the product. The most widely accepted benchmark for establishing safety for electrical medical devices is a standard called IEC60601-1, where compliance has become an acceptable means for satisfying electrical safety requirements for the commercialization of electrical medical devices in the European Union. 60601-1 has undergone revision recently. The third edition is enforced now in the EU and the second Edition is currently applicable in the U.S. The FDA will require the use of the third Edition of the standard for new devices as of June 30, 2013. In this new edition of the standard, there is strong emphasis on risk assessment, ISO 14971 and, in the U.S, a focus on device usability as an important factor contributing to the safety of the device. Product testing to 60601-1 is a very technical exercise that involves laboratory testing against the standard by a test house, such as Underwriters Laboratories. If...