Medical Devices
FDA`s Center for
Devices and Radiological Health (CDRH) is responsible for
regulating firms who manufacture, repackage, relabel, and/or
import medical devices sold in the United States. In
addition, CDRH regulates radiation emitting electronic
products (medical and non-medical) such as lasers, x-ray
systems, ultrasound equipment, microwave ovens and color
televisions.
Medical devices are classified into Class I, II, and III.
Regulatory control increases from Class I to Class III. The
device classification regulation defines the regulatory
requirements for a general device type.
Most Class I devices are
exempt from Premarket Notification 510(k). These are
almost always non invasive devices and are generally not of
substantial importance in preventing impairment of human health.
Class II devices
require Premarket Notification 510(k). As a general rule,
510(k) documentation is used when there is precedence in the
marketplace for a device like yours. This assures the FDA
that the materials and components used for a given application
have already been proven in the marketplace, and that your
product has been designed and manufactured using Good
Manufacturing Practices (GMP).
Most Class III
devices require Premarket Approval. These are usually
devices that are life-sustaining or life-supporting device, or
is for a use which is of substantial
importance in preventing impairment of human health, or presents
a potential unreasonable risk of illness or injury. This
class often requires that you conduct clinical trials using
methods outlined by the FDA.
Pharmaceuticals
FDA's Center for Drug
Evaluation and Research (CDER) is responsible for regulating
firms who are undergoing new drug development, are developing
alternative generic drugs or introducing Over-the-Counter (OTC)
drugs for the marketplace. Each of these different
scenarios require different milestones and approvals to be met.
Edical May will help you navigate the type of approval your
product needs. Whether Edical May and its partners provides the
FDA auditable
documentation or we manage the
clinical
trials process, Edical May will ensure that your
product development and scale-up plan gives you the best
opportunities for success, the first time around.
