nick-otto-articles
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Will The EPA's Sterilizer Assessment Disrupt The Medical Device Industry?
11/21/2014
The Chemical Assessment Advisory Committee (CAAC) of the Environmental Protection Agency’s Science Advisory Board (SAB) met recently to evaluate the agency’s Integrated Risk Information System (IRIS) draft assessment of the carcinogenic effects of ethylene oxide (EO). The final draft conclusion on the risks of EO could have major implications for medical device makers.
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Brazil's ANVISA Seeking Industry Feedback Following Manufacturing Inspections
11/20/2014
Brazil’s medical device regulatory body, the Agência Nacional de Vigilância Sanitária (ANVISA), recently announced that it will now be accepting industry feedback following Brazilian Good Manufacturing Practice (BGMP) inspections.
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Canada Issues New Electronic Formatting Requirements For Class III, IV Devices
11/19/2014
Beginning Dec. 1, 2014, Health Canada, the country’s medical device regulator, is going to require electronic submissions for many high-risk Class III and Class IV medical device license applications.
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What The New Japanese Medical Device Regulations Mean For You
11/12/2014
With a comprehensive regulatory framework for medical devices set to take effect on Nov. 25, Japan’s Pharmaceutical and Medical Devices Agency (PMDA) has made some changes that need to be addressed for device makers looking to remain compliant in the Asian market.
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FDA Sued For Wrongly Detaining Devices
11/11/2014
Two leg brace distributors recently filed lawsuits against the FDA, claiming that the agency improperly detained shipments of their devices after determining the products required premarket clearance.
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Medical Device Tax At The Forefront Following Midterm Elections
11/6/2014
With the Senate being swept up in red, many are speculating that aspects of the Affordable Care Act (ACA) will be amended, particularly the highly contested Medical Device Excise Tax.
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FDA Warns Cook Medical On CAPA, Documentation Procedures
11/5/2014
Bloomington, Ind.-based Cook Medical is on the FDA’s radar following a warning letter calling on the device maker to fix a slew of quality problems at its Indiana facility.
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FDA Expresses Commitment To Development Of Devices For Patients With Disabilities
11/3/2014
The FDA recently emphasized its push to empower the medical device industry in studying and developing new technologies to treat patients with disabilities.
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FDA Chief Details Agency Initiatives To Combat Ebola
10/31/2014
FDA Commissioner Margaret Hamburg this week further detailed the agency’s efforts in battling the Ebola outbreak that began in West Africa.
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Australian Government To Initiate Review Of Medical Device Regulations
10/30/2014
A group of experts will review the Australian Therapeutic Goods Administration’s (TGA) framework for the regulation of medical devices and pharmaceuticals, according to a recent government announcement.