lunes, 11 de septiembre de 2017

CDRH Industry: FDA Issues “Evaluation and Reporting of Age, Race, and Ethnicity Data in Medical Device Clinical Studies” Final Guidance

FDA Logo
Today the FDA issued the “Evaluation and Reporting of Age, Race, and Ethnicity Data in Medical Device Clinical Studies” final guidance, which provides recommendations to improve the quality, consistency and transparency of data on how medical devices perform within specific age, race, and ethnic groups. Proper evaluation and reporting of this data can benefit patients, clinicians, researchers and regulators.
The specific objectives of this guidance are to:
  1. Encourage the collection and consideration of age, race, ethnicity and associated predictive variables (e.g., body size, biomarkers, bone density, etc.) during the study design stage;
  2. Outline recommended analyses of study subgroup data, with a framework for considering demographic data when interpreting overall study outcomes; and
  3. Specify the FDA’s expectations for reporting age, race, and ethnicity-specific information in summaries and labeling for approved or cleared medical devices.
The FDA will discuss this final guidance document and respond to questions during a webinar. 
Webinar Details:
Registration is not necessary.
Date: Tuesday, October 31, 2017
Time: 12:00 – 1:30 pm, Eastern Time
To ensure you are connected, please dial-in 15 minutes prior to the start of the webinar.
To hear the presentation and ask questions:
Dial: 888-566-6150; passcode 7300669 | International: 1-212-287-1854; passcode 7300669
On the day of the webinar, use the following link to view the presentation: https://www.mymeetings.com/nc/join.php?i=PWXW5467008&p=7300669&t=c
Conference number: PWXW5467008
If you have any questions, please contact the Division of Industry and Consumer Education (DICE) in the Center for Devices and Radiological Health (CDRH) at 1-800-638-2041, 301-796-7100 or dice@fda.hhs.gov
Food and Drug Administration
Center for Devices and Radiological Health

No hay comentarios: