How does FDA regulate mobile medical applications? What should companies consider when designing and promoting mobile medical apps? This program will discuss FDA’s Mobile Medical Applications final guidance. Topics include the FDA’s regulatory oversight of mobile medical apps, e.g., software used on smart phones, tablets and other devices. This session will discuss the latest updates from FDA relating to mobile Medical apps.
Tuesday, February 17, 2015 11:00am - Tuesday, February 17, 2015 1:00amPresenter: Amy Fowler
Monday, January 26, 2015 1:00am - Friday, January 30, 2015 2:00amOrganizer: Q1 Productions
The Food and Drug Administration has openly commented on its objective to become more of a proponent and less of an obstacle for innovative pharmaceuticals and medical devices to enter the marketplace. However, the life science industry still views the regulatory approval process as a difficult path to navigate due to stringent requirements for clinical data, lengthy approval timelines and a lack of transparency from the FDA. To improve the relationship between manufacturers and the agency, a collaborative environment must be fostered through effective communication and an understanding of FDA's plans for transforming regulatory pathways into a catalyst for medical innovation.
Wednesday, November 5, 2014 9:30am - Wednesday, November 5, 2014 11:30am
Device manufacturers, biodesign innovators, regulatory specialists, and academics register now for the 3rd Annual UGA Medical Device Regulations Conference! This conference, cosponsored by the US FDA and the University of Georgia’s Office of BioPharma Regulatory Affairs, will provide educational and networking opportunities to help shape the future of medical device advancement from a regulatory science perspective.
Tuesday, November 4, 2014 8:00am - Tuesday, November 4, 2014 9:00amOrganizer: Arlington, Virginia, Q1 Productions
Effective communication with regulatory agencies throughout the clearance and approval process of a medical device continues to be a core challenge for regulatory affairs executives.