Abbreviated 510(k)sThe third type of premarket notification available under the New 510(k) paradigm is the Abbreviated 510(k). This notification was originally authorized for use on a modified device when there exists an issued guidance, an established special control...
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What Are All These Device Review and Approval Pathways? Part 3
The Special 510(k)Under the New 510(k) paradigm (the guidance was published in 1998, so it’s hardly that new), there are 3 ways that sponsors may file a premarket notification for their device. Page 11 of that guidance document contains a flow chart that may help...
Authorization of Emergency Use for an In Vitro Diagnostic Device
For Ebola Virus Detection in Response to the Latest OutbreakThe FDA published a notice in the Federal Register on 13FEB2019 authorizing the emergency use of an in vitro diagnostic device (IVDD) manufactured by Chembio Diagnostic Systems, Inc. This authorization is a...
What Are All These Device Review and Approval Pathways? Part 2
The 510(k) Pathway for Premarket Notification The 510(k) pathway is a premarket approval application process authorized under section 510(k) of the FD&C Act. This type of application is required for all classes of devices that either don’t require a PMA...
What Are All These Device Review and Approval Pathways? Part 1
Classification Leads to PathwayIt can be pretty confusing to look at the medical device regulations to figure out how to submit the appropriate documentation for review, particularly in the light of the many new device programs and guidance being announced monthly....
Modernizing the 510(k) Program
Focus on the Total Product Life Cycle and Promoting Newer Predicate DevicesIn April 2018 the FDA published the Medical Device Safety Action Plan in which the agency first described its current framework for ensuring both existing and new medical devices are safe and...
CDRH Device Review Process Management Assessment
In December, CDRH published a report by consultant group Booz Allen Hamilton evaluating the results of the plans established by CDRH to improve the medical device review process. These plans were based on the recommendations from phase 1 of the assessment (also...
Strategic Plans for Post-Market Safety Surveillance at FDA
The primary tool used by the FDA for drug post-market safety surveillance is the Sentinel System. This system, authorized in 2007 in the FDA Amendments Act, started with a pilot in 2009 and as of 2016 is a fully operational tool for linking and analyzing safety data...