Summary of FDA Guidance on Mobile Medical Apps
Overview On September 25, 2013, the FDA issued its final guidance explaining how it plans to regulate mobile medical applications, or “apps,” under the Federal Food, Drug, and Cosmetic Act (FD&C...
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Ten Things to Know About the New Unique Device Identifier Rule for Medical...
Reprinted with the permission of the Record Reporter, originally printed as “The Future of Medical Recalls” on November 15, 2013. Many medical devices will soon carry a unique identity code, under a...
View ArticleSummary of FDA’s Final Guidance on Dear Health Care Provider Letters
At the beginning of this year, the Food and Drug Administration (FDA) issued its final guidance on the content and format of Dear Health Care Provider (DHCP) letters. DHCP letters are correspondence,...
View ArticleFDA Issues New Draft Guidance on Medical Device Data Systems
On June 20, 2014, the Food and Drug Administration (FDA) issued draft guidance advising that the agency does not intend to enforce compliance with the regulatory controls that apply to medical device...
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