Overview
510(k) Pathway Medical devices that are classified as Class II, and which
can be proven to have a predicate device already commercial- ized generally require 510(k) clearance. Te 510(k) pathway requires significantly less paperwork and data when compared to the PMA pathway, and therefore requires considerably less time and cost.
of 0.7%. 510(k)s submitted with Summaries represent approxi- mately 93.4% of all submissions. A 510(k) Summary includes information upon which a claim of substantial equivalence is based. Te 510(k) Statement is a certification that the 510(k) owner will provide safety and effectiveness information support- ing the FDA finding of substantial equivalence to any person within 30 days of a written request. It appears that medical device companies have determined to provide more rather than less information to the FDA to avoid potential issues in the future.
PMA Pathway Devices that
are permanently implanted into the human body or may be necessary to sustain life and do not have a substantially equiva- lent device on the market are gener- ally considered Class III devices and are
Since 2010, the Food and Drug Administration has com-
municated with medical device industry participants in order to gauge sentiment in regards to the sometimes opaque process. Many companies were worried about the lack of predictability and inconsistencies surround- ing the process, while others worried that policy was not stringent enough. In fact, a 2011 study published in the Archives of Internal Medicine noted Class I devices, which are typically those with minimal risk factors, composed 98.0% of medical devices recalled from 2005 to 2009. Te FDA addressed these concerns by becoming
increasingly stringent in its administration of the 510(k) process, oſten requiring additional infor- mation (“AI”) from companies in order to prove substantial equivalence (“SE”). Te percentage of first-round 510(k) submissions requiring additional information increased from 36.0% in 2002 to 69.0% in Q3 2013. On the other hand, AI requests peaked in 2010 at a rate of 77.0%, likely decreasing aſter- ward as a result of the FDA’s townhall meetings with medical device companies. Ultimately, the elevated instances of AI requests substantively slowed down the 510(k) approval process. Te number of 510(k) clearances has remained relatively flat from 2007 to 2013 growing at a CAGR
16 Medical Manufacturing 2014
required to pass more stringent hurdles. Receiving a PMA for a device can take several years and cost tens of millions of dollars. Upon approval however, there are typically considerably fewer
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