Regulatory Updates: Page 62

FDA clarifies 510(k) device modification rules
By DrBicuspid.com staff writers
The U.S. Food and Drug Administration has issued draft guidance that clarifies when changes or modifications to a previously cleared 510(k) device require a new premarket submission.
July 25, 2011
Oral bisphosphonates may up risk of esophageal cancer
By DrBicuspid.com staff writers
The U.S. Food and Drug Administration is continuing to review data from published studies to evaluate whether the use of oral bisphosphonates is associated with an increased risk of esophageal cancer.
July 20, 2011
2009 07 28 13 33 39 581 Fda Logo 70
FDA mulls regulatory oversight of mobile medical apps
By DrBicuspid.com staff writers
The U.S. Food and Drug Administration (FDA) is seeking input on a proposal to provide oversight of certain mobile applications specific to medicine or healthcare designed for use on smartphones and other mobile computing devices.
July 18, 2011
FTC judge rules that NC dental board acted illegally
By Donna Domino
A U.S. Federal Trade Commission (FTC) judge has ruled that the North Carolina dental board's efforts to block nondentists from providing teeth-whitening services constitute an illegal anticompetitive conspiracy.
July 18, 2011
2009 11 18 10 18 09 377 Gavel 70
P&G recalls 2 mouthwashes in Canada
By DrBicuspid.com staff writers
Procter & Gamble is conducting a voluntary recall of two mouthwash products in Canada due to possible microbial contamination.
July 13, 2011
Irish regulators update dental x-ray position statements
By DrBicuspid.com staff writers
The Radiological Protection Institute of Ireland has published two new position statements for users of dental x-ray equipment that amend its Code of Practice for Radiological Protection in Dentistry.
July 7, 2011
WHO wants more graphic warnings to cut smoking
By Reuters Health
LONDON (Reuters) - More than a billion people in 19 countries are now covered by laws requiring large, graphic health warnings on tobacco packs, but too many countries are still not doing enough to cut smoking rates, the World Health Organization said on Thursday.
July 7, 2011
2010 11 10 12 10 05 453 No Smoking 70
FDA to ease 510(k) rules for some radiology products
By DrBicuspid.com staff writers
The U.S. Food and Drug Administration (FDA) is looking to reduce its regulatory requirements for certain diagnostic products and radiology device accessories that have already been shown to be safe and effective.
July 6, 2011
2009 07 28 13 33 39 581 Fda Logo 70
Antimicrobial surgical masks gain FDA clearance
By DrBicuspid.com staff writers
Filligent has received U.S. Food and Drug Administration (FDA) marketing clearance for the BioFriend BioMask for sale in the U.S. as a class II medical device.
June 27, 2011
FDA clears next-generation NewTom
By DrBicuspid.com staff writers
The U.S. Food and Drug Administration (FDA) has issued marketing clearance for ImageWork's latest cone-beam CT system, the NewTom 5G, the successor to NewTom 3G.
June 21, 2011
FDA unveils final cigarette warning labels
By DrBicuspid.com staff writers
Beginning September 2012, the U.S. Food and Drug Administration (FDA) will require larger, more prominent cigarette health warnings on all cigarette packaging and advertisements in the U.S.
June 20, 2011
2011 06 21 10 23 41 551 Fda Cigarette Warning
N. Ireland's dental school may lose accreditation
By DrBicuspid.com staff writers
The only school of dentistry in Northern Ireland may lose its accreditation from the U.K. General Dental Council over concerns about teaching quality and available resources, the Belfast Telegraph has reported.
June 16, 2011
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