Module 15 Presentations

15/04/2024

PMA/Class III - Clinical Requirements

Main drivers of study size and clinical data requirements include • Claims Will EU clinical requirements be less than US requirements? Not necessarily…

• Variation of patient population – US is seen as more diverse • Standardised medical practice or equivalent surgical application • Whether animal/bench performance studies may be sufficient to answer questions of safety or performance (efficacy) • Significance level, power, variability in the data (standard deviation), difference in treatment effect • Adequate data for sub group analysis

• Sufficient representation of users/environments • Novelty of device relative to standard of care

The Organisation for Professionals in Regulatory Affairs

29

Diversity Plans

Guidance applies to Drugs, Biologics, and Devices

FDA DRAFT GUIDANCE – “Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials Guidance for Industry”  Sponsors define enrollment goals for under-represented racial and ethnic participants in clinical development for a given indication  Race And Ethnicity Diversity Plan: Plan should begin with assessment of any data that may indicate the potential for a medical product to have differential safety or effectiveness associated with race or ethnicity  Sponsors should submit their Plan as part of the investigational plan included in the IDE application and/or discuss in a Q-Submission  May only be applicable to certain diseases or medical device types https://www.fda.gov/regulatory-information/search-fda-guidance-documents/diversity-plans improve-enrollment-participants-underrepresented-racial-and-ethnic-populations

The Organisation for Professionals in Regulatory Affairs

30