Certification Standards - Using Event-B for Critical Device Software Systems - page 310

A.4 FDA

The Food and Drug Administration (FDA) [ 20 ] is established by US Department of
Health and Human Services (HHS) in 1930 for regulating the various kinds of prod-
uct like food, cosmetics, medical devices, etc. The FDA is now using standards in the
regulatory review process to provide safety to the public before using any product.
The FDA allows manufacturers to submit the declaration of conformity to satisfy
premarket review requirements. The FDA provides some guidelines on the recog-
nition use of and consensus standards. The FDA is interested in standards because
they can help to serve as a common yardstick to assist with mutual recognition,
based on the signed Mutual Recognition Agreement between the European Union
and United States. More than ever before, standards will have the more prominent
role for the review of medical devices. The FDA also recognises ISO/IEC and IEEE
standards [ 13 , 14 ]. Basic goals of the FDA standard are:

• To promote health by reviewing research and approving new products.

• To ensure foods and drugs are safe and properly labelled.

• To work with other nations to “reduce the burden of regulation”.

• To cooperate with scientific experts and consumers to effectively carry out these

obligations.

The FDA standard classifies the medical devices based on risk and use of med-
ical devices. The FDA provides some standard guidelines for medical devices, and
medical devices have required to meet these standards. Time to time lots of amend-
ments have been done in the FDA standards [ 7 , 20 ] according to the use of medical
devices to provide safety.
The Center for Devices and Radiological Health (CDRH) [ 5 ] is the branch of
the FDA, which is responsible for ensuring the safety of medical devices and elim-
inating unnecessary radiation from the medical products [ 7 , 19 , 20 ]. It provides
standards for medical products from the simple toothbrush to complex devices such
as pacemakers. The CDRH [ 5 ] also checks the safety performance of non-medical
devices, which emit certain types of electromagnetic radiation like cellular phones,
screening equipment, microwave ovens, etc. The CDRH has some standards, which
are used to describe many aspects of a medical device related to premarket and
post-market issues. Here, we briefly mention some basic concepts [ 7 , 20 ]involved
in FDA regulation for medical devices:

• Class I devices are defined as non-life sustaining. These products are the least

complicated and their failure poses little risk.

• Class II devices are more complicated and present more risk than Class I, though

are also non-life sustaining. They are also subject to any specific performance
standards.

• Class III devices sustain or support life, so that their failure is life threatening.