nick-otto-articles
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FDA Takes Initiative To Fill Gender Data Gaps In Device Clinical Trials
6/30/2014
In its continued effort for more thorough analysis on the efficacy of medical devices in subpopulations, the FDA is looking to find ways at filling the gender gaps currently seen in clinical trial participation.
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FDA Cuts Its Oversight Of Medical Device Data Systems
6/25/2014
The FDA has released new draft guidance on medical device data systems (MDDS) that further extends its original downgrade to a Class 1 device in 2011 and reduces the regulatory burden for MDDS developers. MDDS are systems used to collect, store, convert formats, and display data from other devices, like glucose meters, blood pressure cuffs, and weight scales.
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FDA Asks Device Makers To Balance Benefit/Risk Info In Social Media
6/19/2014
In long awaited guidance for industry on social media, the FDA this week asked industry to maintain a balanced amount of information due to “character space limitations imposed by platform providers may not enable meaningful presentations of both benefit and risk.”
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New FDA Guidance Exempts Manufacturers From Correcting Online Third-Party Claims
6/19/2014
The FDA, in new draft guidance, says industry has no obligation to correct misleading statements or claims made about their products by third-parties on social media, on websites, and through online forums.
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CDRH Provides Update On Initiative To Make Review Process Faster, More Transparent
6/16/2014
Jeffrey Shuren, director of the Center for Device and Radiological Health (CDRH), last week gave a status report on plans to improve the consistency and efficiency of the FDA’s medical device review process, one of several recommendations provided to the agency following an independent review.
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FDA Issues Guidance On First Phase Of GDUID Implementation
6/11/2014
On Wednesday, the FDA issued the first phase of its global unique device identification database (GUDID) guidance, detailing how to set up accounts and begin making submissions. However, updates to the guidance on the device identifiers themselves won’t be released until a later date.
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EU Approves Electrical Safety Standards, Harmonizes With Device Directive
6/10/2014
All device makers manufacturing within the European Economic Area must ensure their products conform to the third edition of the EN 60601 electrical safety standard by December 31, 2017.
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OpenFDA Initiative To Provide Easier Access To Agency Data
6/6/2014
This week, the FDA kicked off its newest transparency initiative, openFDA, with a new database containing millions of reports of adverse events that were previously available only through difficult-to-use reports or Freedom of Information Act requests.
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FDA Releases Information On UDI Rule Exceptions
5/30/2014
The FDA last week provided industry with some reprieve from the Unique Device Identification (UDI) rule, providing some exemptions, alternatives, and time extensions.
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FDA Downgrades Risk Class of Drainage Stents, Tuberculosis Tests
5/30/2014
The FDA has issued final reclassification orders for several devices, moving them to a less stringent Class II with control category.