Specialized FDA user comprehension consultants for consumer genomics
User comprehension is critical to authorization – and the future of genetic testing.
Regulatory agencies often require data collection – such as an FDA user experience study, label comprehension study, self-selection study, and other evaluative or clinical studies. These needs fit perfectly within our consulting and data collection service expertise. Specifically, SoundRocket’s user comprehension study service is managed in-house by an expert team of genetic counselors, survey methodologists and research/data collection specialists who have experience in completing studies for medical devices that have successfully gained FDA approval.
Seeking help with FDA mandated data collection?
Consult with SoundRocket’s genetic testing experts to see how we can help you.
Experts in label comprehension, FDA premarket authorization, and other related studies are positioned to assist with:
Direct-to-consumer (DTC) genetic testing services
We have successfully navigated this path with multiple genetic test medical device manufacturers—resulting in FDA 510k clearance
Our FDA label comprehension studies use iterative, interview-based stages in the development and refinement of report contents and user comprehension questionnaire validity. We have also worked with NIH, NIDA, CDC, NSF, and NIAAA funding on multiple primary research studies.
Our primary research team engages with several academic research teams including PeopleSeq, pGen, and others on the topic of the social impacts of genetic testing. Our research collaborators in this area come from institutions such as Harvard University, the University of Minnesota, the University of Michigan, Jackson Laboratories, Duke University, among others.
Having worked with Ancestry.com, 23andMe, Oneome and others, SoundRocket understands the current needs and requirements around the U.S. Food & Drug Administration (FDA) regulatory pathways for Direct-to-Consumer (DTC) personal genetic testing, including:
Carrier Screening Tests (21 CFR 866.5940)
Genetic Health Risk (GHR) Tests (21 CFR 866.5950)
Pharmacogenetics Tests (21 CFR 862.3364)
Cancer Predisposition Tests (CFR 21 866.6090)
The next decade will revolutionize how humans interface with their genes. Helping to study this relationship and ensure that people understand is where we, at SoundRocket, come in.