Nanotechnology is the engineering of functional systems at the molecular scale. This covers both current work and concepts
that are more advanced.
In its original sense, 'nanotechnology' refers to the projected ability to construct items from the bottom up, using
techniques and tools being developed today to make complete, high performance products.
The U.S. Food and Drug Administration (FDA) regulates a wide range of products, including foods, cosmetics, drugs, devices,
veterinary products, and tobacco products some of which may utilize nanotechnology or contain nanomaterials. Nanotechnology
allows scientists to create, explore, and manipulate materials measured in nanometers (billionths of a meter). Such
materials can have chemical, physical, and biological properties that differ from those of their larger counterparts.
The United States is the global leader in medical device innovation and the Food and Drug Administration's (FDA) Center for
Devices and Radiological Health (CDRH) is committed to assuring that American patients have timely access to important new
technologies and next-generation products without compromising their safety. Each year, millions of American patients benefit
from innovative medical devices that reduce suffering, treat previously untreatable conditions, extend lives, and improve
public health. CDRH is responsible for advancing public health and facilitating innovation to help bring novel technologies
to market and make the medical devices that are already on the market safer and more effective.
CDRH recognizes that transformative innovative devices typically present new scientific and regulatory challenges. The
Innovation Initiative supports the development of innovative products by addressing some of the barriers that can impede a
product’s timely progress to market.
The Medical Device Innovation Initiative proposes actions CDRH could take to help accelerate and reduce the cost of
development and regulatory evaluation of innovative medical devices safely and based on sound science. These actions include:
* Facilitate the development and regulatory evaluation of innovative medical devices;
* Strengthen the U.S. research infrastructure and promote high-quality regulatory science; and
* Prepare for and respond to transformative innovative technologies and scientific breakthroughs.
The FDA has identified a possible association between breast implants and the development of anaplastic large cell lymphoma
(ALCL), a rare type of non-Hodgkin’s lymphoma. ALCL is not cancer of the breast tissue. The FDA believes that women with
breast implants may have a very low but increased risk of developing ALCL adjacent to the breast implant. A literature review
identified 34 unique cases of ALCL in women with breast implants worldwide. In total, the agency is aware of approximately 60
cases of ALCL in women with breast implants that were identified through the FDA’s contact with other international
regulatory agencies, scientific experts and breast implant manufacturers. This is a very small fraction of the 5-10 million
women who have received breast implants worldwide.
Additional data is needed to fully understand the possible relationship between ALCL and breast implants. The FDA is asking
health care providers to report all confirmed cases of ALCL in women with breast implants through FDA’s MedWatch Program.
that are more advanced.
In its original sense, 'nanotechnology' refers to the projected ability to construct items from the bottom up, using
techniques and tools being developed today to make complete, high performance products.
The U.S. Food and Drug Administration (FDA) regulates a wide range of products, including foods, cosmetics, drugs, devices,
veterinary products, and tobacco products some of which may utilize nanotechnology or contain nanomaterials. Nanotechnology
allows scientists to create, explore, and manipulate materials measured in nanometers (billionths of a meter). Such
materials can have chemical, physical, and biological properties that differ from those of their larger counterparts.
The United States is the global leader in medical device innovation and the Food and Drug Administration's (FDA) Center for
Devices and Radiological Health (CDRH) is committed to assuring that American patients have timely access to important new
technologies and next-generation products without compromising their safety. Each year, millions of American patients benefit
from innovative medical devices that reduce suffering, treat previously untreatable conditions, extend lives, and improve
public health. CDRH is responsible for advancing public health and facilitating innovation to help bring novel technologies
to market and make the medical devices that are already on the market safer and more effective.
CDRH recognizes that transformative innovative devices typically present new scientific and regulatory challenges. The
Innovation Initiative supports the development of innovative products by addressing some of the barriers that can impede a
product’s timely progress to market.
The Medical Device Innovation Initiative proposes actions CDRH could take to help accelerate and reduce the cost of
development and regulatory evaluation of innovative medical devices safely and based on sound science. These actions include:
* Facilitate the development and regulatory evaluation of innovative medical devices;
* Strengthen the U.S. research infrastructure and promote high-quality regulatory science; and
* Prepare for and respond to transformative innovative technologies and scientific breakthroughs.
The FDA has identified a possible association between breast implants and the development of anaplastic large cell lymphoma
(ALCL), a rare type of non-Hodgkin’s lymphoma. ALCL is not cancer of the breast tissue. The FDA believes that women with
breast implants may have a very low but increased risk of developing ALCL adjacent to the breast implant. A literature review
identified 34 unique cases of ALCL in women with breast implants worldwide. In total, the agency is aware of approximately 60
cases of ALCL in women with breast implants that were identified through the FDA’s contact with other international
regulatory agencies, scientific experts and breast implant manufacturers. This is a very small fraction of the 5-10 million
women who have received breast implants worldwide.
Additional data is needed to fully understand the possible relationship between ALCL and breast implants. The FDA is asking
health care providers to report all confirmed cases of ALCL in women with breast implants through FDA’s MedWatch Program.
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