Page 46 - Biomedical Engineering and Design Handbook Volume 2, Applications

FDA MEDICAL DEVICE REQUIREMENTS 25

following this procedure, they have the force and effect of law. Violation of an FDA regulation is the
same as violation of the FDCA.
It should be noted that the FDCA is a criminal enforcement act. Violation of the FDCA is a
misdemeanor punishable by up to a year in jail and fines. Repeated violation may be a felony.

2.5 WORKING WITH FDA

It should be noted that working with FDA on medical devices can be an extremely interactive per-
sonal experience. It is not like the anonymous interaction with the Internal Revenue Service or other
U.S. agencies. In work relating to medical devices, you may continually run into the same FDA per-
sonnel. This builds a continuing relationship unlike the normal conduits into government.
For example, your company may have its product clearance applications reviewed by the same
group for a decade. You will learn their likes and dislikes in style. You will learn their particular view
of what the regulations mean. You may grow to personally like or dislike them as individuals. In most
cases, however, you must learn to manage this long-term, long-range relationship in a professional
manner that advances the cause of your company.
FDA personnel are dedicated to the mission of consumer protection. This devotion may
occasionally lead individuals to leap to conclusions about you or your company. You must be
prepared for zealous advocacy by FDA personnel in accomplishment of their mission. At times
it will seem unfair and arbitrary. You must learn how to work within this system and keep up the
working relationship.

2.6 SCOPE OF REGULATION

FDA regulates the entire life cycle of a medical device, from cradle-to-grave. The examples below
demonstrates the major regulations affecting a device through its life:

• Design stage (post research) • Quality System Regulation (QSR) Design Control
• Bench testing • QSR Design Control
• Animal testing • Good Laboratory Practices (GLP)/Design Control
• Human testing • Investigational Device Exemption (IDE)/Design Control
• Market clearance • 510(k)/PMA
• Manufacturing • QSR Process Control, etc.
• Distribution • QSR Traceability
• Postmarket • Complaint handling/QSR/Corrective and Preventive
Action (CAPA)/Medical Device Reports (MDR)

2.7 MARKETING CLEARANCE OF MEDICAL DEVICES

There are basically two paths through the FDA system to arrive at marketing of a product: Premarket
Approval and 510(k) (sometimes called Premarket Notification). In order to understand these paths,
it is best to learn the history behind them, starting from the Medical Device Amendments of 1976.
Congress was faced with creating a comprehensive plan for the wide range of medical devices. It
had to establish a system that could regulate both dental floss and implantable heart valves. It was
faced with public pressure to address problems perceived with some devices, such as intrauterine
devices (IUDs) for birth control, while not disturbing the great mass of low-risk products that
appeared to be successful and safe.