Practical Advice for Medical Devices Firms | Page 2
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Understanding Regulatory Pathways and Clinical
Development to Ensure a Successful Commercial Entry
For medical devices, good engineering does not guarantee clinical trial or
commercial success. The climate for introducing new medical devices into
the market has become increasingly difficult in recent years. At times,
regulators and device manufacturers seem to be on opposing sides of the
playing field. Regulators often contend with pressure to fast-track
approvals while at the same time ensuring product safety and efficacy.
On the other hand, manufacturers risk spending time and resources to
develop a device, only to not receive approval to go to market. Executing
a successful market strategy involves navigating the U.S. Food and Drug
Administration (FDA) approval process, designing and conducting
efficient clinical trials, adeptly evaluating the existing marketplace.
Navigating regulatory pathways
The FDA's Center for Devices and Radiological Health (CDRH) is
responsible for regulating firms who manufacture medical devices sold in
the United States. The FDA classifies devices into one of three categories.
Class I devices have the lowest potential for harm. Examples are
bandages, crutches, and examination gloves. Class II devices, such as
powered wheelchairs, infusion pumps, EKG machines, and orthopedic
drills, are subject to special controls that might include special labeling,
performance standards, and post market surveillance. Class III devices are
the most serious and invasive. Examples would be pacemakers, stents,
endovascular grafts, and heart valves. Device classification defines the
regulatory requirements for a general device type.
Premarket Notification 510(k) and Premarket Approval
Most Class I devices are exempt from the FDA’s Premarket Notification
510(k) (FDA, Overview of Device Regulation). The 510(k) is a premarket
submission to demonstrate that a device is as safe and effective as a
predicate device. If this is established, clearance is given to the product.
Most Class II devices require Premarket Notification 510(k). Most Class III
devices require Premarket Approval. Premarket approval is the most
stringent requirement for a new device. It is expensive, time consuming
and requires extensive clinical data.
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