FDA Genetic Health Risk User Comprehension
Guiding you through the complexities of FDA Genetic Health Risk User Comprehension to ensure your product’s clarity and compliance.
The Challenges of Conducting a User Comprehension Test for 510(k) Approval Independently
Navigating the complexities of regulatory requirements, study design, and data analysis on your own can be daunting.
Complex Regulatory Requirements
Understanding and adhering to detailed FDA guidelines is crucial, yet can be overwhelming without specialized regulatory expertise.
Effective Study Design
Developing a robust study protocol that ensures valid and reliable assessment of user comprehension requires meticulous planning and extensive knowledge.
Data Analysis
Interpreting and drawing actionable insights from user comprehension data demands advanced analytical skills and a deep understanding of statistical methodologies.
Supporting FDA approval through effective user comprehension studies.
Ensure your genetic health risk product meets FDA requirements and is market-ready with our specialized user comprehension studies.
We design and implement science-guided, defensible studies that are targeted, rigorous, and led by experts.
Create, design, and edit health-related content
We craft precise, clear content tailored to user comprehension requirements for FDA approval.
Design & implement FDA-grade studies
We develop and execute comprehensive studies that meet rigorous FDA standards.
Develop reports for an FDA submission
We generate detailed, compliant reports to support your FDA 510(k) submission.
Support study-related FDA communications
We assist with clear and effective communication for all FDA study-related inquiries.
Provide end-to-end project management
SoundRocket’s User Comprehension Co-Pilot
Expert Review
Our team conducts thorough expert reviews to ensure your study meets all regulatory and scientific standards.
Expert Survey Design
We craft meticulously designed surveys that accurately measure user comprehension and adhere to FDA requirements.
Self-Administered Design
We offer online self-administered study protocols that facilitate easy participation and reliable data collection.
Faster Survey Results
Collect results faster leading to shorter studies.
Lower Costs
Save on travel, administration, and recruitment costs.
Larger Sample Sizes
Dedicate more of your budget towards larger sample sizes.
Meet all FDA Requirements
Co-pilot is a perfect fit for FDA-grade studies.
The Co-Pilot human factors / comprehension study lifecycle
Co-Pilot is an established 3-step approach to FDA studies. It can be pre-market or post-market studies, moderated or self-administered design, with consumers or healthcare providers.
Prep It.
Optimize your product label or test report for success.
Design a study protocol to meet the FDA’s expectations.
Pilot It.
Refine product labelling and study protocols based on user interviews.
Pilot test the final design before launching full study.
Prove It.
Run the study to meet FDA’s data collection and reporting needs.
Deliver an FDA-ready study report.
Maintain It.
Maintain regulatory compliance and customer satisfaction as needed when regulations change, products are updated, or user feedback is gathered.
SoundRocket stands as your trusted ally in achieving excellence in survey research.
With our unwavering dedication to perfection and ensuring your satisfaction, we present unmatched services tailored to precisely meet your research requirements with the utmost professionalism.
Methodological Expertise
We have deep knowledge to design rigorous, effective user comprehension studies.
Collaborative Approach
Work closely with our team for tailored solutions and successful project outcomes.
Customization and Flexibility
Bespoke study designs that adapt to your unique product and regulatory needs.
Attention to Detail and QA
Meticulous quality assurance ensuring accurate and reliable results.
Ethical Standards & Privacy
Commited to ethical practices and stringent data privacy protections.
Timely and Responsive
Experience prompt, reliable communication and swift project execution.
A headline about what we do to implement the study...
With our unwavering dedication to perfection and ensuring your satisfaction, we present unmatched services tailored to precisely meet your research requirements with the utmost professionalism.
Study Planning, Design, & Management
Study Implementation
Analysis & Scholarly Reporting
Thorough analysis and detailed reports meeting FDA standards for clear, actionable results.
Client Successes
We just got clearance from the FDA for the AlphaID At Home Service for OTC use!
USER COMPREHENSION STUDY
Genetic Health Risk Test
I will be sure to recommend SoundRocket to others seeking approval in the US.
LABEL COMPREHENSION STUDY
EU Medical Device Granted US FDA Clearance.
This morning, we got FDA clearance for both products! Thank you so much for getting us to this point
USER COMPREHENSION STUDY & ACTUAL USE STUDY
Genetic Health Risk Test & Saliva Collection Kit
From the Launchpad
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At the end of April 2024, the FDA finalized its rule on Laboratory Developed Tests (LDTs), marking a significant regulatory shift. Labs now face a phased compliance process over four years, adapting to stringent requirements. SoundRocket specializes in human factors and user comprehension studies, essential for FDA submissions. We provide comprehensive support through user and label comprehension studies, simulated use studies, and regulatory guidance. With proven expertise in FDA submission support, SoundRocket ensures your LDTs meet regulatory standards efficiently. Embrace the new regulatory landscape with confidence by partnering with SoundRocket. Visit our services page to learn more.
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Expert advice on designing DTC genetic test reports
There is little published guidance on how to present genetic or genomic results in an understandable way and at an appropriate reading level for a typical consumer.1 Most of the literature on developing genetic test reports for non-experts (i.e., anyone without...