Biomedical Engineering Reference
In-Depth Information
Planning, conducting, and coordinating CDRH actions regarding approval, denial, and
withdrawals of 510(k)s, PMAs, and IDEs.
Ongoing review, surveillance, and medical evaluation of the labeling, clinical experience,
and required reports submitted by sponsors of approval applications.
Developing and interpreting regulations and guidelines regarding the classification of
devices, 510(k)'s, PMAs, and IDEs.
Participating in the development of national and international consensus standards.
Everyone who develops or markets a medical device will likely have multiple interac-
tions with ODE before, during, and after the development of a medical device.
In principle, if a manufacturer makes medical claims about a product, it is considered a
device, and may be subject to FDA pre- and postmarket regulatory controls (Figure 2.5).
The device definition distinguishes a medical device from other FDA-regulated products,
such as drugs. According to the FDA, a medical device is:
An instrument, apparatus, machine, contrivance, implant, in vitro reagent, or other similar or related
article intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment,
or prevention of disease in man or other animals OR intended to affect the structure or any function of the
body of man or other animals, and which does not achieve any of its primary intended purposes through
chemical action or is not dependent upon being metabolized.
Needs &
Intended
Uses
Design Input
Process
R
eview
Require-
ments
Initial Design
Stage
Possible
Interim
Reviews
Stage 1
Design
Output
. . .
N
th
Design
Stage
V
erification
Final
Design
Output
Production
V
alidation
Test
Articles
FIGURE 2.5
The purpose of the regulatory process is to conduct product review to ensure (1) device safety and
effectiveness, (2) quality of design, and (3) surveillance to monitor device quality. Therefore, the review process
results in verification and validation of the medical device.
