Regulatory Updates: Page 36

FDA: Relief ACP oral care gel recalled
By DrBicuspid.com staff writers
The U.S. Food and Drug Administration (FDA) announced that Relief ACP oral care gel was voluntarily recalled by manufacturer Discus Dental because of an "incorrect composition of ingredients." The company mistakenly filled the gel product with hydrogen peroxide teeth-whitening gel, which made it ineffective or could cause increased sensitivity.
December 18, 2014
FDA approves Gardasil 9 vaccine for 9 HPV types
By DrBicuspid.com staff writers
The U.S. Food and Drug Administration (FDA) has approved the Gardasil 9 vaccine for preventing certain diseases caused by nine types of human papillomavirus (HPV).
December 10, 2014
Zimmer proposes package to win EC approval of Biomet deal
By DrBicuspid.com staff writers
Zimmer Holdings has proposed a remedy package to the European Commission (EC) to facilitate the EC's approval of Zimmer's proposed acquisition of Biomet.
December 4, 2014
Texas court invalidates rules on Medicaid payment holds
By Donna Domino
A Texas appeals court has invalidated several rules related to payment holds imposed during Medicaid fraud investigations, saying they violate due process rights. The decision sides with plaintiffs Harlingen Family Dentistry and Trueblood Dental Associates and also reverses a trial court's ruling.
December 1, 2014
2013 11 18 17 15 05 637 Gavel 200
FTC urges accreditation standards for dental therapy programs
By DrBicuspid.com staff writers
U.S. Federal Trade Commission (FTC) staff today submitted comments to the Commission on Dental Accreditation (CODA), urging CODA to finalize and adopt accreditation standards for dental therapy education programs.
November 30, 2014
Biolux's OrthoPulse gets clearance in Canada
By DrBicuspid.com staff writers
Biolux Research announced that OrthoPulse has received a medical device license from Health Canada and is now commercially available in Canada. The device was cleared as a class II medical device according to the Canadian Medical Device Regulations.
November 24, 2014
Benevis announces certification of EHR system
By DrBicuspid.com staff writers
Benevis, a business support services company for healthcare practices, announced the certification of its Boomerang electronic health records (EHR) system by the Drummond Group's Electronic Health Records Office of the National Coordinator Authorized Certification Body program.
November 23, 2014
NSK Dental receives ISO 13485 certification
By DrBicuspid.com staff writers
Dental equipment manufacturer NSK Dental announced that it has received International Organization for Standardization (ISO) 13485 certification for its North American distribution and repair services. This certification applies specifically to medical device manufacturers.
November 20, 2014
Lymphoseek earns EU marketing authorization
By DrBicuspid.com staff writers
Navidea Biopharmaceuticals announced that it has received marketing authorization in the European Union (EU) for its Lymphoseek 250-mcg kit for radiopharmaceutical preparation.
November 19, 2014
Zimmer, European Commission extend review deadline for Biomet acquisition
By DrBicuspid.com staff writers
Zimmer Holdings announced that it has agreed with the European Commission (EC) to extend the deadline for the EC's review of Zimmer's proposed acquisition of Biomet by a limited number of days to provide the EC with certain additional information.
November 18, 2014
Study warns against using unsafe handheld x-ray devices
By Rabia Mughal
Handheld x-ray devices are used widely in dental practices across the U.S., but are they always safe? That depends on the device, according to a new study in the Journal of the American Dental Association. The study authors warn dental professionals to be cautious and use only those devices that have been cleared by the Food and Drug Administration.
November 11, 2014
2014 11 11 23 33 10 179 Xray Unsafe Device 200
First Do No Harm: Part 2 -- The standard of care in eye protection
By Noel Kelsch, RDHAP
In the second part of this series, Noel Kelsch, RDHAP, writes that successful infection control and clinician safety depend on every clinician being ethical and following laws, regulations, recommendations, and the standard of care.
November 11, 2014
2014 11 14 14 49 22 928 Kelsch Noel 200
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