FDA
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FDA Applies Genome Sequencing in Outbreak Investigation
The U.S. Food and Drug Administration recently put whole genome sequencing technology — which maps the entire DNA sequences of…
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Medtech approvals: FDA releases March 2014 PMAs
May 22, 2014 by MassDevice staff The U.S. Food & Drug Administration releases a list of pre-market approvals granted in March 2014.…
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Spine
Eminent Spine Passes Second Consecutive FDA Inspection
Georgetown, TX, May 15, 2014 –(PR.com)– Eminent Spine is pleased to announce that it has passed two consecutive inspections conducted…
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FDA Unveils Plan for Expedited Device Approvals
The U.S. Food and Drug Administration (FDA) has unveiled a proposal designed to speed up development and approval of medical…
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FzioMed Announces Date for Medical Device Dispute Resolution Panel on Oxiplex®
SAN LUIS OBISPO, Calif.–(BUSINESS WIRE)–FzioMed, Inc., a medical device manufacturer specializing in biomaterials, has received notification from FDA that the…
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Biologics
ReGen Biologics appeals loss to FDA
April 9, 2014 by Brad Perriello ReGen Biologics asks a federal appeals court to overturn its loss of a lawsuit filed against…
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CDRH’s Office of Compliance Reorganization
CDRH has recently overhauled its Office of Compliance — what exactly has changed and what hasn’t? What does your team…
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Uncategorized
FDA Proposes Medical Device Rule to Simplify Classification Process
The Food and Drug Administration is proposing to amend its regulations governing classification and reclassification of medical devices to conform…
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Hospitals
FDA’s Lost $85 Million in Users Fees So Far Due to Sequestration
The White House’s Office of Management & Budget confirms that the federal sequester has drained about $85 million in user…
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Hospitals
Federal shutdown would mean FDA delays
A federal shutdown could push back FDA reviews and facility inspections amid a furlough of nearly half of the agency’s…
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Hospitals
FDA Outlines Rules For Medical Apps On Phones, Tablets
Drug regulators are taking a look at smartphone and tablet applications that help patients monitor their health and connect with…
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The FDA’s Medical Device Program Is Broken
In July, a subcommittee of FDA’s Science Board released a cleared-eyed 37-page report on what it called the “financial and strategic threats”…
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FDA’s Device Program Really is in Crisis
In July, a subcommittee of FDA’s Science Board released a cleared-eyed 37-page report on what it called the “financial and…
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FDA Trial Data Disclosure Could Impede Device Innovation
The FDA proposal to divulge clinical trial data as a means of speeding diagnostics and therapeutics to market continues to…
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FDA Proposes Fiscal 2014 User Fee Rates
The FDA wants to raise the user fees paid by medical device companies for the watchdog agency’s review by 4.2%…
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