Medical Device Regulatory Bodies

I read a paper recently from Dr. Taylor and Dr. Kazanzides (developers of the ROBODOC system) that describes well the different regulatory procedures for medical devices. This should be posted to follow up the previous post on the ROBODOC system's approval.

"The medical device industry is a heavily regulated industry. In
the United States, medical devices must be cleared for market
by the Food and Drug Administration (FDA). There are two
paths to market. One is via the 510(K) premarket notiWcation
process and the other is via the premarket approval (PMA)
process. A manufacturer can obtain a 510(K) clearance if the
new device is ‘‘substantially equivalent’’ to an existing device
that is already on the market. Otherwise, the PMA application
is required. Surprisingly, several medical robots obtained
clearance via the 510(K) path, including Aesop (Computer
Motion, Inc.), Neuromate (Innovative Medical Machines
International), and daVinci (Intuitive Surgical). In contrast,
the earlier ROBODOC System (Integrated Surgical Systems)
started down the PMA path and in the first round it has not received
clearance. ROBODOC was tested in multiclinical trials in the
United States under an investigational device exemption,
which is the mechanism by which FDA authorizes limited
clinical trials to gather supporting data. In August 2008 it received a 510(k) approval.
In addition to the need for 510(K) or PMA approval medical
device companies must comply with the quality system regulations
(QSR) and are periodically audited by the FDA to verify
compliance. Initially, the FDA required companies to adhere to
good manufacturing practices, which regulated just the manufacturing
phase. For simple devices, this worked well because
device failures were primarily due to manufacturing Xaws. As
devices became more complex, especially with the integration
of computers and software, the FDA discovered that a large
number of device failures were due to design Xaws rather than
to manufacturing Xaws. The infamous Therac-25 accident,
where six patients received massive overdoses of radiation
from a computer-controlled medical linear accelerator, is
a well-known example. As a result, FDA QSR began to
regulate the design phase as well.
In the European market, all products (medical or otherwise)
require Conformité Européenne (CE) marking. Furthermore,
the design and manufacturing processes must comply with
International Standards Organization (ISO) 9001 and 9002,
respectively (often these are grouped together by the term ISO
9000). The CE marking and ISO 9000 certiWcation are handled
by a number of notiWed bodies, which are independent, nongovernmental
To comply with ISO 9000 and/or FDA QSR, medical device
companies must deWne their development and manufacturing
processes and then produce documents (quality system records)
that demonstrate adherence to these processes. Although
ISO 9000 and FDA QSR are similar, they are not
identical, which requires most medical device companies to
comply with both of them."

Source: R. H. Taylor, P. Kazanzides, "Medical Robotics and Computer-Integrated Interventional Medicine". Chapter 18 in Biomedical Information Technology by D. D. Feng (Editor), 2007


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