Best Practices: Which activities related to clinical research and medical devices are considered qualified? Which activities are considered non-qualified?

MASSIE says:

Activities related to clinical research that are considered qualified include:

• Clinical studies/investigations performed in-house or by outside Contract Research Organizers (CRO) in the US.
• Preparing and collecting documentation required for regulatory submissions and internal research files.
• Doctors or other scientists serving in a consultative role as part of the clinical research process.

Activities related to medical devices that are considered qualified include:

• Designing/Engineering new product designs.
• Modeling/building/testing prototypes.
• Performing manufacturing test runs on new products.
• Modifying manufacturing processes to improve quality, speed, yield, and efficiency to reduce cost, and reduce waste.
• Testing (including sterility and QA) prior to regulatory approval.
• Serving as a liaison between customers and the development team to identify desired design improvement

Activities related to the medical industry that DO NOT qualify include:

• Manufacturing of existing products.
• Repairs, maintenance, and bug-fixes.
• Customer technical support or helpdesk.
• Post-approval/release analysis and testing.
• Other non-R&D related matters (HR, management, budgeting, marketing, customer relations, training, 2^nd level and above management, etc.)
• Post-market research/surveillance, market research, customer education.
• All employee/contractor time spent working outside the US.

Please contact the MASSIE team if you want to discuss this topic further or require assistance with your calculations.

Disclaimer: The information on this website is for general information purposes only. Nothing on this site should be taken as legal advice for any individual case or situation.