How do I know if my device will be reviewed by the human factors team at FDA?
On February 3, 2016, FDA/CDRH issued a draft guidance regarding a list of devices that have been classified as “high priority” for human factors oversight at the agency. This list, which appears in this guidance, makes it clear that the designated devices will require human factors testing and reporting in premarket clearance submissions. Devices not appearing on the list are subject to human factors requirements on a case-by-case basis depending on a variety of factors appearing in the guidance but centered on the risk profile of the device and/or post-market problems reported by predicates or similar devices. See the draft guidance for all factors that determine human factors requirements.
The Human Factors Pre-Market Evaluation Team (HF-PMET) at the FDA/CDRH Office of Device Evaluation (ODE) is called upon to provide “consults” on certain pre-market device submissions such as 510(k)s, Pre-Market Approvals (PMAs), and Investigational Device Exemptions (IDEs). The lead reviewer for your submission will make a decision as to whether the device use risk appears to be sufficient to warrant human factors review. Several factors may interact regarding this decision.
For home healthcare, the need for human factors review may be higher because of use by non-professional users. Devices with known use safety problems are of high priority. For example, infusion pumps, automatic external defibrillators (AEDs), and ventilators are in this category.
Combination products are now almost always evaluated for human factors work by the CDER Division of Medication Error Prevention and Analysis (DMEPA) group.
Should my human factors work be presented as one document or can it be distributed throughout a submission? What works best for the agency’s review process?
The CDRH and CDER human factors teams advocate using the CDRH guidance’s report outline to organize and present your human factors and usability work. This assures that you have provided all the needed information for reviewers to make a fair and complete assessment of your human factors work. When information is scattered It makes it difficult for reviewers to find key information supporting your argument that your device is safe and effective for use.
Are formative tests required by FDA? How should they bet presented? Are complete test reports and protocols required?
Formative tests are not a requirement. However, the FDA human factors report has a section for discussing and summarizing your formative work. A tabular summary of studies and their findings is an excellent way to inform reviewers about your work. You may be asked to provide more details of particular formative studies, but the main purpose for the section Is to assure the agency that you have been engaged in an iterative process with your user interface design including user testing to eliminate risk caused by design flaws.