- FDA
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- FDA official site
- Mission
FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human
and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and
products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed
innovations that make medicines and foods more effective, safer, and more affordable; and helping the public
get the accurate, science-based information they need to use medicines and foods to improve their
health.
- What FDA regulates
- FDA regulations
Code of Federal Regulations (CFR) is a codification of the general and permanent rules published in the
Federal Register by the Executive departments and agencies of the Federal Government. Title 21 of the CFR is
reserved for rules of the Food and Drug Administration.
- FDA and Medical devices
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- Center for devices and radiological health (CDRH)
- Importing into the U.S.
- Good Guidance Practice (GGP)
Guidance Practice (GGP) documents are documents prepared for CDRH staff, regulated industry and the
public that relate to:
a) the processing, content, and evaluation of regulatory submissions,
b) the design, production, manufacturing, and testing of regulated products,
c) the inspection and enforcement procedures.
- Regulatory requirements
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- Device classification
FDA divides all devices in three regulatory classes based on the level of control necessary to assure the
safety and effectiveness of the device.
- Classification database
- Premarket notification 510(k)
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- What is premarket notification [510(k)]
Each person who wants to market Class I, II and some III devices intended for human use in the U.S. must
submit a 510(k) to FDA at least 90 days before marketing unless the device is exempt from 510(k)
requirements.
- Predicate device/devices
510(k) requires demonstration of substantial equivalence. SE means that the new device is as safe and
effective as the predicate device(s). A device is SE if, in comparison to a predicate device it:
a) has the same intended use as the predicate device; and
b) has the same technological characteristics as the predicate device; or
c) has different technological characteristics, that do not raise new questions of safety and effectiveness,
and the sponsor demonstrates that the device is as safe and effective as the legally marketed device.
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- Search 510[k] database
- Substantial equivalence comparison
The device specifications are the basis for the comparison of features between the new and the legally
marketed device to which compared (predicate device). Substantial equivalence is to be established with
respect, but not limited to, intended use, design, energy used/delivered, materials, performance, safety,
effectiveness, labeling and other applicable characteristics, such as sterility.
- Statement of indications of use
The statement should include specific indications, clinical settings, define the target population,
anatomical sites, etc. This statement must be consistent with your labeling, advertising and instructions for
use.
- Find guidances
The statement should include specific indications, clinical settings, define the target population,
anatomical sites, etc. This statement must be consistent with your labeling, advertising and instructions for
use.
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- Documents for submission
- Software
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