Medical devices are products/devices used by a medical
practitioner for diagnosis, surgery or any other type of therapy to cure
patients (human or animal). According to Food and Drug Administration (FDA),
Medical devices are classified within approximately 1,700 different types and
can be broadly summarized within a total of 16 specialties which are described
as panels. In order to assure the safety and efficiency of medical devices
FDA has assigned three categories. These three
classifications are defined by control limits of medical devices, which
are, Class I General Controls, Class II General
Controls and Special Controls and Class III General Controls and Premarket
Approval. These classifications are
based on the intended use of medical devices as well as on their usage
indications.
Medical industry
today is expanding at a rapid pace and producing enormous opportunities and
businesses throughout globe. New technologies and new benchmarks are set almost
every day. Manufacturers are adopting sophisticated technologies and using best
level of engineering for designing and mass production of these medical
devices. Be it a temperature monitoring thermometer or robotics used for
complicated heart surgeries. Best strategies and marketing practices are used
in positioning these highly evolved medical devices. Innovative technologies
and engineering are being used for mass production of such medical devices.
Thus have transformed medical field as one of the most demanding industry in
the market.
Due to these
increased demands and complexity involved in medical devices it has become
essential to maintain a classified system which can ensure regulatory practice
in this field. Thus the importance of regulatory practices is essential in
order to maintain quality standards in medical devices. FDA has set up a
separate department under the name Center for Devices and Radiological Health
(CDRH) whose responsibility is to not only to monitor the firms who are
involved in manufacturing and packaging the medical devices but also monitors
radiation emitting medical devices like x-rays, ultrasound, MRIs, etc.
Medical devices regulatory requirements are broadly followed for
Establishment registration, Medical Device Listing, Premarket Notification or
Approval, Investigational Device Exemption for clinical studies, Quality System
regulation, Labeling requirements and Medical Device Reporting.
These FDA medical
device compliance and regulatory practices are only to promote and protect the
public health. These practices are enforces through different acts regulator by
FDA just to ensure the safety and effectiveness of these devices. Thus these
compliance are must and has to be followed by each manufacturer or produces to
attain a level or quality standards and maintain their FDA compliance stature.
