Biomedical Engineering Reference
In-Depth Information
and the Agency. At this time, FDA has not adopted nanotechnology-specific criteria to assist manufac-
turers in determining when a change to a device that contains nanomaterials or otherwise involves the
application of nanotechnology rises to the level of significance that requires submission of a new 510(k).
For this reason, FDA recommends that manufacturers consult with the agency for any nanotechnology-
related changes to devices to determine whether and how the change may affect the safety or effec-
tiveness of the device. FDA plans on developing additional guidance to further explain the Agency's
thinking on this matter. Contact the appropriate review division with any questions on devices that
contain nanomaterials or otherwise involve the application of nanotechnology.
*
The note demonstrates that the CDRH, like the other FDA centers, believes that the use of nano-
materials at least raises questions about whether there has been a fundamental change in the risk
associated with use of the device, and the proof of whether that is so or not will be the centerpiece
of any application involving a change to engineered nanomaterials in a regulated product. What the
CDRH says also raises the issue of whether the center believes that the manufacturer has the option
to make its own determination about whether the change in materials affects safety. The CDRH has
no guidances at present. It did, however, host a public workshop to discuss nanomaterials in devices
products. In advance of the meeting, the CDRH posted a document asking for comment on a variety
of issues.
†
Finally, the Center for Food Safety and Applied Nutrition (CFSAN) has issued two guidelines,
one for cosmetics and one for food, that contain important information about the agency's thinking
on the regulation of nanotechnology. The first document discusses the proof of safety for cosmet-
ics incorporating engineered nanomaterials.
‡
There has been concerted opposition to the use of
nanomaterials in cosmetics, especially fullerenes, because they pose a significant theoretical risk to
users without a perceived benefit that would be worth any risk. Manufacturers do not have to submit
premarket applications for cosmetics, but they are responsible for the generation and preservation
of data demonstrating safety. Critics think that is not sufficient, but that is the way it is unless the
United States Congress amends the statute. In the meantime, the CFSAN has issued the guidance,
stating at the outset that:
At the nanoscale, properties of materials might change resulting in changes to the product's perfor-
mance, quality, safety, and/or effectiveness (Ref. 2). Nanomaterials may have chemical, physical, or
biological properties that are different from their larger counterparts. The use of nanomaterials may
alter the bioavailability of the cosmetic formulation (Ref. 5). In some of these cases, the traditional
safety tests that have been used to determine the safety of cosmetic ingredients and finished products
may not be fully applicable. As noted in the 2007 FDA Nanotechnology Task Force report, there may
be a higher degree of uncertainty associated with nanoscale materials compared to conventional chemi-
cals, both with respect to knowledge about them and the way that testing is performed. In Section III.B
of this document, we highlight key scientific considerations relevant to the assessment of the safety of
nanomaterials used in cosmetic products.
If you wish to use a nanomaterial in a cosmetic product, either a new material or an altered version
of an already marketed ingredient, FDA encourages you to meet with us to discuss the test methods and
data needed to substantiate the product's safety, including chronic toxicity and other long-term toxicity
data as appropriate.
§
*
U.S. Food and Drug Administration. Guidance for Industry and FDA Staff - 510(k) Device Modifications: Deciding When to
Submit a 510(k) for a Change to an Existing Device. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/
GuidanceDocuments/ucm265274.htm.
†
U.S. Food and Drug Administration. 2010. Public workshop—Medical devices and nanotechnology: Manufacturing,
characterization, and biocompatability considerations, questions for discussion. http://www.fda.gov/MedicalDevices/
NewsEvents/WorkshopsConferences/ucm222591.htm.
‡
U.S. Food and Drug Administration. 2012. Draft guidance for industry: Safety of nanomaterials in cosmetic products.
http://www.fda.gov/Cosmetics/GuidanceComplianceRegulatoryInformation/ GuidanceDocuments/ucm300886.htm.
§
Id
. at 8.
