FDA goes global
- FDA Seeks Comments on its eCopy Program. Goedert, Joseph // Health Data Management;Dec2012, Vol. 20 Issue 12, p22
The article reports that the U.S. Food and Drug Administration (FDA) is seeking public comments on its draft guidance on the eCopy program for electronic submission of information on medical devices.
- FDA addresses unmet pediatric medical device needs with three grants. // Infectious Diseases in Children;Oct2009, Vol. 22 Issue 10, p56
The article announces the grants issued by the U.S. Food and Drug Administration (FDA) for the development of pediatric medical device.
- FDA proposes new tanning bed requirements, including skin cancer warnings. // Hem/Onc Today;6/25/2013, Vol. 14 Issue 12, p47
The article focuses on a proposal by the U.S. Food and Drug Administration (FDA) to reclassify sunlamp products from low-risk to moderate-risk devices.
- FDA eyes expansion of device tracking. // Medical Device Daily;5/10/2011, Vol. 15 Issue 90, p7
The article reports on the plan of the U.S. Food and Drug Administration to expand its medical tracking device category.
- FDA approves premarket application for melanoma device. // Hem/Onc Today;11/25/2011, Vol. 12 Issue 22, p13
The article reports on the premarket approval given by the U.S. Food and Drugs Administration for MelaFind, a device used for gaining information on indeterminate pigmented skin lesions.
- FDA recommends stricter regulations for tanning beds. // Hem/Onc Today;5/25/2010, Vol. 11 Issue 10, p15
The article reports on that the U.S. Food and Drug Administration (FDA) called for an increased use of tanning beds through classifying them to class II medical devices with restrictions or possibly class III medical devices.
- FDA streamlines medical device voting process. // Hem/Onc Today;5/25/2010, Vol. 11 Issue 10, p16
The article reports on the plan of the U.S. Food and Drug Administration (FDA) to modify its process of assessing and discussing data during public hearings about medical devices being considered for premarket approval.
- Red flags on reuse. Perry, Philip A. // Materials Management in Health Care;Dec99, Vol. 8 Issue 12, p16
Focuses on the United States Food and Drug Administration's proposed strategy on reuse of single-use medical devices. Phase-in of moderate-risk standards; Impact of reuse on cost reduction.. INSET: SUDs strategy in brief.
- FDA proposes speedier path for medical devices. Pecquet, Julian // Hill;2/9/2011, Vol. 18 Issue 15, p14
The article reports on the proposal of the U.S. Food and Drug Administration (FDA) to ease the approval process of cutting-edge medical devices but consumer groups are doubtful as it could possibly bring danger to patients.
- FDA Starts Submission Tracker Program. // Orthopedic Design & Technology;Sep/Oct2015, Vol. 11 Issue 6, p18
The article offers information on the pilot program develop by the U.S. Food and Drug Administration (FDA) for a website-portal that can be used by medical device companies to monitor the way their devices progress in the regulatory processes of the agency.