Medical Technology Regulations for the U.S. Market

This aim of this module is to ensure that participants recognize and understand the requirements and are competent in application methods and processes to achieve approval or clearance for medial devices in the U.S.  The FDA is the mandated regulatory body responsible for medical device approval & clearance for the U.S. market.  Students will benfit from interaction with tutors who have worked in the U.S. and dealt direcly with the FDA.  This first hand knowledge will help students to understand the processes and penalties for this region.  

The ability to deliver the contents of a Pre-market approval or 510(k) application will be a desired deliverable. 

1. Describe and apply the principle requirements for route to U.S. market for medical devices.  Evaluate and conclude the relevant submission content for a PMA or 510(k) clearance. Justify the 'substantial equivalence' rule based on device classification.  Substantiate the benefit of the 'third party' review process.

2. Develop U.S. Regulatory strategy incorporating defined FDA timelines to include pre-submission meetings, predicting likely internal & external obstacles.    Assess and justify suitable file structure and content to meet 510(k) and PMA applicaiton requirements.  Distinguish between the CDRH role, office of device evaluation & compliance oversight functions.

3. Evaluate and complete device changes post release to determine the change classification, compile substantial change notifications in line with supplements, 30 day notices or other relevant filing mechanism.   Interpret the rules and extrapolate the technical data required to fulfill FDA submission questions.

4. Indicate and illustrate the use of FDA guidance and consensus standards and incorporate into regulatoy business systems.  Demonstrate competence in use of the FDA.GOV website to ensure currenct concepts and expectations are achieved and vast education sources are considered.