Nanotechnology—Over a Decade 

of Progress and Innovation

A REPORT BY THE U.S. FOOD AND DRUG ADMINISTRATION 

Issued July 2020
Contents

I. Executive Summary................................................................................................................................... 1

II. Introduction.............................................................................................................................................. 3

A. The Current State of Nanomaterials Science and Nanotechnology.................................................. 3

B. FDA’s Nanotechnology Task Force Report and Progress................................................................... 5

III. Science-Based, Product-Focused Regulatory Policy for Nanotechnology............................................. 6

A. Guidance for Industry .......................................................................................................................... 6

IV. Strengthening Regulatory Science Research in Nanotechnology ......................................................... 9

A. Strengthening Research Infrastructure for Nanotechnology ............................................................. 9

B. CORES (Collaborative Opportunities for Research Excellence in Science) Intramural Grants 

Program .................................................................................................................................................. 11

C. Supporting Nanotechnology-related Staff Training and Professional Development......................13

V. Collaborating with Federal Agencies, Academic Institutions, and International Partners.................14

A. Domestic and International Coordination ....................................................................................... 15

B. Providing Leadership in International Standards Development...................................................... 19

VI. Future Perspectives .............................................................................................................................. 20

VII. Appendix: FDA Nanotechnology Core Facility and Advanced Characterization Facility Equipment 

List............................................................................................................................................................... 21
Nanotechnology – A Decade of Progress and Innovation: 

A Report by the U.S. Food and Drug Administration

I. Executive Summary 

According to the National Nanotechnology Initiative,

1 nanotechnology2 includes the 

control of matter at the nanoscale, where unique phenomena and unusual properties 

enable novel applications. The creation of the National Nanotechnology Initiative (NNI) 

in the year 2000, jump-started research and development investments by U.S. 

government agencies in nanotechnology, resulting in significant advances in this field 

and enabling novel solutions to complex problems. 

Anticipating an increase in the submissions to FDA of products that involve the 

application of nanotechnology, the then-Acting Commissioner of the Food and Drug 

Administration (FDA) launched the Nanotechnology Task Force (NTF) in 2006 to help 

assess FDA's regulatory authorities concerning the current state of the science for 

nanotechnology. The NTF released a comprehensive public report in 2007 highlighting 

its findings and recommendations to the Commissioner. Since the release of this 

report, FDA has seen a gradual increase in the number of submissions for products 

containing nanomaterials submitted for regulatory review. 

With a dedicated nanotechnology budget, FDA has continued to strengthen our

research infrastructure by establishing two core facilities to support nanotechnology 

regulatory science research and to build scientific expertise and capacity. FDA has 

conducted internal research on advanced physico-chemical characterization, in vitro

biocompatibility, and in vivo safety studies to ascertain the critical quality attributes of 

nanomaterial, and to prepare FDA scientists and reviewers for the emerging products.

Additionally, FDA has increased collaboration with external domestic and international 

stakeholders to: 

• anticipate emerging challenges;

• build and share regulatory science knowledge;

• facilitate innovation; and 

• coordinate policy to fulfill FDA's mission. 

FDA has also increased its participation in the development and use of both national 

and international documentary nanotechnology standards. It has issued several 

guidance documents for industry to offer FDA’s current thinking on the subject and 

provide advice, including advice relevant to determining the regulatory status of 

nanotechnology products and evaluating their safety. The strengthening of FDA’s 

 1https://www.nano.gov/nanotech-101/what

2 FDA has not established regulatory definitions of “nanotechnology,” “nanomaterial,” “nanoscale,” or 

other related terms. However, for the purpose of this update, when describing FDA’s activities, we use the 

terms “nanotechnology,” “nanomaterial,” and “nanotechnology product” to refer to examples that would 

generally fall within the two points for considering whether an FDA-regulated product involves the 

application of nanotechnology articulated in the Agency’s guidance for industry, Considering Whether an 

FDA-Regulated Product Involves the Application of Nanotechnology, which are further discussed in 

Section III.A. below. 
Nanotechnology – A Decade of Progress and Innovation: 

A Report by the U.S. Food and Drug Administration

2

research infrastructure has enabled the Agency to make a significant contribution to 

public knowledge in this area, as evidenced by the publication of hundreds of peerreviewed articles.

This report highlights FDA’s advancements in the field of nanotechnology since it 

released its last report in 2007,

3 and its role in advancing the public health through its 

regulation of products within its jurisdiction that involve the application of 

nanotechnology. Moving forward, FDA will continue to:

• monitor scientific and technological advancements and convergence of 

emerging technologies with nanotechnology;

• support standards development through stakeholder involvement;

• collaborate with other agencies through NNI;

• conduct regulatory science research to understand the science to advance 

public health and make resulting information available to the public; and

• support innovative development of beneficial nanotechnology products. 

 3 https://www.fda.gov/science-research/nanotechnology-programs-fda/nanotechnology-task-force-report2007
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II. Introduction 

The U.S. Food and Drug Administration (FDA) is responsible for protecting the public 

health by ensuring the safety, effectiveness, quality, and security of human and animal

drugs, vaccines as well as other biological products, and medical devices. FDA is also 

responsible for the safety of most of our nation’s food supply, as well as cosmetics, and 

products that emit radiation. Additionally, FDA regulates tobacco products. 

Nanotechnology, which involves the engineering and control of matter at small 

dimensions, has potentially beneficial applications in a wide range of FDA-regulated 

product categories. As nanotechnology products continue to evolve, such as moving 

from simple systems to highly complex, multi-component, multi-functional materials, so 

do FDA’s efforts to understand the science and advance public health by supporting 

innovation for developing beneficial nanotechnology products.

FDA anticipates that nanotechnology may play a critical role in the design, 

development, and manufacture of next-generation products – including drugs, medical 

devices, and foods. While many basic questions and assumptions have been 

addressed, and many best practices and standards concerning nanotechnology 

applications have been established and continue to be updated by the scientific 

community, it is critical that FDA develop an advanced understanding of new

nanomaterials in the emerging products from a safety, efficacy, and physicochemical 

characterization perspective to fulfill our mission to protect and promote public health. 

A. The Current State of Nanomaterials Science and Nanotechnology 

Since our last report in 2007, rapid advancements in fields such as life sciences, 

engineering, and medicine have increased our knowledge and understanding of 

nanotechnology and its current and potential applications in FDA-regulated products. 

Nanotechnology has also converged with other fields, such as biotechnology, which has 

the potential to improve our understanding of biosystems at the molecular level, and 

make possible the discovery of innovative solutions to unmet health needs. Such 

advances are reflected in the diversity, complexity, and volume of products included in

regulatory submissions for FDA review.

For example, since 1970, FDA’s Center for Drug Evaluation and Research (CDER) has 

received more than 600 applications (investigational new drug (IND), new drug 

application (NDA), and abbreviated new drug application (ANDA)) for human drug 

products containing nanomaterials – half of which were submitted within the last 10 

years.4 Figure 1 shows the submission trend of drug products containing nanomaterials 

submitted to CDER over the years.

 4 D’Mello S et al. FDA/CDER analysis of drug products containing nanomaterials, Nature Nanotechnology 

12(6) 523-529 (2017).
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Figure 1: Human drug product submissions to FDA containing nanomaterials between 1970-2019.

FDA is also aware of research into the use of nanomaterials in animal drugs. FDA’s 

Center for Veterinary Medicine (CVM) has approved a few new animal drug applications 

for animal drugs that use nanotechnology. Due to this technology’s diverse advantages, 

FDA’s Center for Devices and Radiological Health (CDRH) has also seen an increase in 

the number of premarket notifications (510(k)) and premarket approval applications 

(PMA) that specify the incorporation of discrete nanoparticles or use of nanoengineered surfaces with specific performance claims, ranging from antimicrobial 

activity to enhanced cell proliferation and tissue integration.

There have also been scientific advances that show promise for the development or 

analysis of nanotechnology-derived products in foods (including dietary supplements) 

and cosmetics; FDA encourages stakeholders to consult with the Agency when 

exploring use of new technologies in such submissions. For example, FDA’s Center for 

Food Safety and Applied Nutrition (CFSAN) is conducting research to ensure that FDA 

scientists are ready to address new challenges that may arise when reviewing future 

applications of nanotechnology to CFSAN-regulated products. 

The Office of Regulatory Affairs (ORA), continues to conduct collaborative research to 

develop analytical methods for detecting and characterizing nanomaterials in FDAregulated products. Such methods will enable FDA to identify potential risks associated 

with products that contain nanomaterials through pre- and postmarket oversight. Once 
Nanotechnology – A Decade of Progress and Innovation: 

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validated, these methods can be useful to sponsors and reviewers for future approval of 

products. 

Additionally, FDA’s National Center for Toxicological Research (NCTR) is carrying out

research to help FDA better understand novel scientific issues associated with

nanomaterial use. This research informs the work of FDA reviewers who evaluate the

safety of nanotechnology-based products and is incorporated into internal FDA training 

programs to share information about nanotechnology and nanotechnology applications 

in FDA-regulated products with Agency scientists.

B. FDA’s Nanotechnology Task Force Report and Progress 

In 2006, FDA initiated a process to improve its scientific knowledge of nanotechnology 

to ensure that FDA scientists were prepared to address regulatory challenges that 

nanotechnology products may present. FDA created a nanotechnology task force 

(NTF) charged with identifying regulatory approaches that encourage the continued 

development of innovative, safe, and effective FDA-regulated products that use this 

technology, and to identify and recommend ways to address knowledge or policy gaps 

to enable FDA to evaluate innovative products and protect the public health.

In 2007, the NTF issued a report that found that nanotechnology use presents 

regulatory challenges like those posed by products using other emerging technologies. 

It made several recommendations for FDA action on scientific and regulatory policy 

issues concerning nanotechnology to further our mission to protect and promote public 

health.5

In the years since this report was issued, our understanding of different nanomaterials 

and their interactions with biological systems, as well as specific approaches for 

assessing safety and quality of nanotechnology products, has greatly increased. FDA

continues to use a science-based, flexible, product-focused regulatory approach that 

considers the effects of nanomaterials in the specific biological and mechanical context 

of each product and its intended use. In developing our approach to ensuring our 

readiness to evaluate this technology, FDA has also prioritized training staff, building 

research capacity and infrastructure, and forging partnerships to strengthen our 

regulatory science research capabilities. 

FDA collaborates with and leverages the work of other federal agencies, academic 

institutions, and international regulatory counterparts on important issues, such as 

characterization of nanomaterials and standards development. FDA has also worked to 

help provide our stakeholders with additional clarity about the Agency’s current thinking 

 5 Nanotechnology – A Report of the U.S. Food and Drug Administration Nanotechnology Task Force, 

July 25, 2007 (Available at: https://www.fda.gov/science-research/nanotechnology-programsfda/nanotechnology-task-force-report-2007).
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on regulatory issues through guidance documents, and has worked to develop 

procedures to ensure consistency in our product reviews. 

FDA is issuing this update6 to discuss these and other efforts we have taken to advance 

nanotechnology science and policy since the 2007 NTF report, including those aligned 

with recommendations of that report. FDA has made great progress in its efforts to 

better understand nanotechnology applications in FDA-regulated products. This will 

help to ensure that FDA continues to be prepared to effectively and efficiently evaluate 

emerging and evolving technologies and ensure the safety, quality, and efficacy of the 

products we regulate. 

III. Science-Based, Product-Focused Regulatory Policy for Nanotechnology 

As part of our implementation of the 2007 report, FDA has clarified our regulatory 

approach to nanotechnology products and has issued guidance for industry.

FDA does not categorically judge nanotechnology products as intrinsically benign or 

harmful. Rather, by applying a science-based, product-focused regulatory policy, FDA

regulates nanotechnology products under existing statutory authorities, in accordance 

with the specific legal standards applicable to each type of product under the Agency’s

jurisdiction. This approach enables FDA to consider any unique properties and 

behaviors that the use of nanotechnology may impart as part of its evaluations of a 

product’s safety, effectiveness, public health impact, or regulatory status. In addition, 

recognizing that FDA’s statutory authorities vary among different product categories, 

this flexibility enables FDA to tailor its approach to reflect the characteristics of specific 

products, considering the biological or, where applicable, mechanical context relevant to 

the product’s intended use. 

Other key attributes of FDA’s policy approach include encouraging industry to consult 

with the Agency early in product development to identify and address any questions of 

safety or regulatory status; actively communicating with the public to share information 

and seek input; and collaborating with domestic and international counterparts to 

advance regulatory science and cooperation.7

A. Guidance for Industry 

FDA has issued guidance for industry to offer advice, including advice to determine the 

regulatory status of nanotechnology products and evaluating their safety. While 

guidance documents provide recommendations that are not binding, they are a valuable 

tool for FDA to communicate our current thinking on a topic, and can help provide 

 6 This document is intended to inform stakeholders of FDA’s nanotechnology science and policy 

development work; it is not intended to provide guidance or recommendations, or establish new policy. 7 FDA’s Approach to Regulation of Nanotechnology Products, last updated March 23, 2018 (Available at: 

https://www.fda.gov/ScienceResearch/SpecialTopics/Nanotechnology/ucm301114.htm). 
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additional clarity for our stakeholders. To date, FDA has issued five final guidance 

documents and one that is currently in draft form. Each of these was developed with 

stakeholder input that was received through a public docket and/or at public meetings.

 Final Guidance for Industry: Considering Whether an FDA-Regulated Product 

Involves the Application of Nanotechnology8 – This guidance describes an 

overarching framework for FDA’s approach to the regulation of nanotechnology 

products and identifies two points to consider that are broadly applicable to all FDAregulated products. When considering whether an FDA-regulated product involves 

the application of nanotechnology, FDA will ask:

1) whether a material or end product is engineered to have at least one external 

dimension, or an internal or surface structure, in the nanoscale range 

(approximately 1 nm to 100 nm); and

2) whether a material or end product is engineered to exhibit properties or 

phenomena, including physical or chemical properties or biological effects, that 

are attributable to its dimension(s), even if these dimensions fall outside the 

nanoscale range, up to one micrometer (1,000 nm). 

We intend to apply these considerations broadly to all FDA-regulated products. An 

affirmative finding to either of the points to consider might suggest the need for 

FDA’s and/or industry’s particular attention to the product to identify and address 

potential implications for its safety, effectiveness, public health impact, or regulatory 

status.

 Final Guidance for Industry: Safety of Nanomaterials in Cosmetic Products9 –

This guidance describes FDA’s current thinking on the safety assessment of 

nanomaterials in cosmetic products. The guidance explains that, in general, the 

principles for assessing the safety of cosmetics also apply to cosmetics containing 

nanomaterials. However, data needs and testing methods should be evaluated 

considering the properties, behaviors, and/or effects that may be exhibited by 

nanomaterials used in cosmetic products.

 Final Guidance for Industry: Assessing the Effects of Significant 

Manufacturing Process Changes, including Emerging Technologies, on the 

Safety and Regulatory Status of Food Ingredients and Food Contact 

 8 Final Guidance for Industry: Considering Whether an FDA-Regulated Product Involves the Application 

of Nanotechnology, June 2014 (Available at: 

https://www.fda.gov/RegulatoryInformation/Guidances/ucm257698.htm). 

9 Final Guidance for Industry: Safety of Nanomaterials in Cosmetic Products, June 2014 (Available at: 

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industrysafety-nanomaterials-cosmetic-products.
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Substances, Including Food Ingredients that are Color Additives10 – This 

guidance informs manufacturers of the potential impact of a significant 

manufacturing process change, including one involving nanotechnology, on the 

safety and regulatory status of food substances. This guidance describes the 

factors that manufacturers should consider when determining whether a significant 

change in manufacturing process for a food substance already in the market affects:

the identity of the food substance; the safety of the use of the food substance; and 

the regulatory status of the use of the food substance; and whether this change

warrants a regulatory submission to FDA.

 Final Guidance for Industry: Use of Nanomaterials in Food for Animals11 – This 

guidance addresses the legal framework for adding substances to food for animals 

and includes recommendations for submitting a Food Additive Petition (FAP) for a 

nanomaterial animal food ingredient. This guidance also recommends that 

manufacturers consult with FDA early in the development of their nanomaterial 

animal food ingredient and before submitting an FAP.

 Final Guidance for Industry- Liposome Drug Products12 – This guidance 

discusses what types of information an applicant should submit in a new drug 

application (NDA) or abbreviated new drug application (ANDA) for a liposome drug 

product reviewed by CDER. The discussion involves chemistry, manufacturing, and 

controls; human pharmacokinetics, bioavailability, and/or bioequivalence; and 

labeling. This guidance is the first “class-specific” guidance on a particular type of 

nanomaterial. Liposomes comprise more than a third of the nanotechnology 

submissions CDER receives.

 Draft Guidance for Industry – Drug Products, Including Biological Products, 

that Contain Nanomaterials13 – This draft guidance, issued for public comment, 

discusses both general principles and specific considerations for developing drug 

products containing nanomaterials, including those products proposed in 

applications submitted pursuant to abbreviated approval pathways. The document 

discusses considerations for quality, nonclinical, and clinical studies as they relate to 

 10 Final Guidance for Industry: Assessing the Effects of Significant Manufacturing Process Changes, 

including Emerging Technologies, on the Safety and Regulatory Status of Food Ingredients and Food 

Contact Substances, Including Food Ingredients that are Color Additives, June 2014 (Available at: 

https://www.fda.gov/RegulatoryInformation/Guidances/ucm300661.htm). 

11 Final Guidance for Industry: Use of Nanomaterials in Food for Animals, August 2015 (Available at: 

https://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/

UCM401508.pdf). 

12 Final Guidance for Industry: Liposome Drug Products: Chemistry, Manufacturing, and Controls; Human 

Pharmacokinetics and Bioavailability; and Labeling Documentation, April 2018 

https://www.fda.gov/media/70837/download 13 Draft Guidance for Industry – Drug Products, Including Biological Products, that Contain 

Nanomaterials, December 2017 (Available at: 

https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM5888

57.pdf). 
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drug products containing nanomaterials throughout product development and 

production. The comment period ended on March 19, 2018, and FDA is reviewing 

public input received to determine what revisions may be necessary before issuing a 

final guidance document. 

For additional information about FDA’s guidance documents relevant to nanotechnology 

products please visit FDA’s website.

14 

IV. Strengthening Regulatory Science Research in Nanotechnology 

FDA’s strategy for strengthening nanotechnology-related research relies on a robust 

framework that coordinates regulatory science activities across all FDA product centers. 

FDA’s 2013 Nanotechnology Regulatory Science Research Plan lays out a framework 

and implementation plan to provide coordinated leadership on regulatory science 

activities on products that contain nanomaterials.15 The framework is designed to help 

FDA identify and address gaps in scientific knowledge, methods, or tools needed for 

regulatory decision-making. This work fosters the responsible development of FDAregulated products that involve the application of nanotechnology by strengthening the 

research infrastructure to support nanotechnology regulatory science research;

promoting cross-center coordination through a nanotechnology-specific intramural 

grants program; and building in-house scientific expertise and capacity to train our 

scientists to address data gaps and critical aspects of nanotechnology product reviews.

A. Strengthening Research Infrastructure for Nanotechnology 

To support and facilitate regulatory science research involving nanotechnology and 

address regulatory challenges across all FDA product centers, FDA established two 

nanotechnology core facilities in 2011. One is located at FDA headquarters in 

Maryland, and the other at the Jefferson Labs in Arkansas. These core facilities were 

designed to: 

1) provide FDA researchers with a centralized set of characterization tools and 

technical support to conduct nanotechnology-related research;

2) give FDA reviewers hands-on training in nanotechnology and materials 

characterization to bridge knowledge gaps in product review and regulatory 

science; and 

3) conduct research on FDA-regulated products to address specific regulatory 

issues and establish the foundation for science-based decisions.

The nanotechnology core facility in Arkansas (NanoCore) is a joint effort by NCTR, 

FDA’s Office of Regulatory Affairs Arkansas Laboratory (ORA/ARKL), and the U.S. 

Department of Health and Human Services National Toxicology Program (NTP). It 

 14 https://www.fda.gov/ScienceResearch/SpecialTopics/Nanotechnology/ucm602536.htm

15 https://www.fda.gov/ScienceResearch/SpecialTopics/Nanotechnology/ucm273325.htm
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supports regulatory science research at NCTR and ORA and supports the work of other

FDA centers, including CDER, CFSAN, and CDRH.

The NanoCore facility has advanced state-of-the-art equipment in spectroscopy, particle 

size, surface composition, stability analysis, and characterization, elemental analysis, 

microscopy, separation/fractionation, and chromatography to support the needs of 

NCTR and ORA/ARKL investigators and research personnel who conduct analyses in 

nanotechnology (See Appendix). 

The equipment housed in the NanoCore facility enables FDA to develop analytical 

methods to accurately monitor nanotechnology-based, FDA-regulated products to 

ensure safety, and, where appropriate, effectiveness. Key research that has been 

performed at the NanoCore/NCTR includes nanomaterial identification and 

characterization in FDA-regulated products; evaluation of sunscreens & their dermal 

penetration potential; pharmacokinetics, efficacy, and biodistribution studies to support 

in vivo and in vitro correlations; cellular- and geno-toxicity; and host resistance assays 

to determine the effects of bioaccumulation of nanoparticles. 

For example, one significant study at NCTR, which is supported by the NTP, evaluated 

particulate and ionic forms of silver and silver particle size for differences in silver 

accumulation, distribution, morphology, and toxicity when administered daily by oral 

gavage to Sprague-Dawley rats for 13 weeks.

16 Compared to rats exposed to silver 

acetate, rats exposed to silver nanoparticles showed: differences in the distributional 

pattern and morphology of silver deposits; significant dose-dependent and silver 

nanoparticle size-dependent tissue accumulations of silver; and significant sex 

differences in silver tissue accumulations.

The Advanced Characterization Facility at FDA’s Maryland headquarters campus, 

includes many of the same state-of-the-art instruments seen in the Arkansas NanoCore 

Facility, and is available for use by on-site and visiting FDA scientists. The facility is 

operated and managed by members of the CDRH research team in the Office of 

Science and Engineering Laboratories. Work in the Advanced Characterization Facility

focuses on developing and advancing the methods, tools, and approaches that will 

improve and enhance the evaluations of the physico-chemical characterization, safety, 

and efficacy of engineered nanomaterials in medical products. Research projects at the 

Advanced Characterization Facility are focused on four broad areas of investigation: 

1) complex drug products and medical devices containing discrete nanoparticles, 

such as liposomes, emulsions, nanosilver and iron-oxide;

2) medical devices with immobilized surface nanostructures and topographies for

orthopedic and dental implant applications;

3) genotoxicity assessment of nanomaterials using standard and alternative 

methods; and

4) developing provisional tolerable intake values for nanomaterials using 

toxicological risk assessment approaches. 

 16 Boudreau MD et al., Differential Effects of Silver Nanoparticles and Silver Ions on Tissue Accumulation, 

Distribution, and Toxicity in the Sprague Dawley Rat Following Daily Oral Gavage Administration for 13 

Weeks. Toxicological Science 150(1) 2016.
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B. CORES (Collaborative Opportunities for Research Excellence in Science) Intramural 

Grants Program 

Regulatory science research in nanotechnology is inherently multidisciplinary, drawing 

from scientific disciplines such as chemistry, biology, and physics. Advances in 

multidisciplinary research have led to an increased number of products developed 

through applications of novel science and technology and products that include aspects

regulated by multiple FDA product centers. As such, FDA believes that intramural 

collaboration is essential for addressing the increasingly complex regulatory landscape;

understanding how these new technologies affect product safety, efficacy, and quality;

and providing information to inform development of regulatory policy relevant to these 

innovations. To address these needs and foster cross-cutting research activities in 

nanotechnology, FDA developed the competitive CORES intramural grants program in 

2010. 
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Figure 2. Representative transmission electron microscopy images of liver, spleen, and lung samples of 

mice 3 days after infection with Listeria. Different dosing groups of mice were pretreated with gold, silver, 

and silica nanoparticles, vehicle control and a positive control CY prior to Listeria infection.

Arrow: CY-Spleen (day 3) shows presence of Listeria monocytogenes in the spleen.”

This study informed guidance and review activities17.

 17 Khan S et al. Investigating the susceptibility of mice to a bacterial challenge after intravenous exposure 

to durable nanoparticles. Nanomedicine 12(17) 2017.
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The CORES grants program is designed to promote cross-center and external 

collaborative research opportunities to address high-priority FDA regulatory science 

nanotechnology research needs. These identified research needs reflect the priorities 

of National Nanotechnology Initiative (NNI) - Environmental, Health, and Safety 

Research Strategy, including nanomaterial characterization, assessing nanomaterial 

biocompatibility, and investigating toxicokinetics, in vitro toxicity, and in vivo toxicity 

testing for nanomaterials.18 Research outcomes from CORES grants have provided

data (Figure 2) to support the issuance of guidance documents for industry and the 

development of vital regulatory science tools, such as assays, assessment 

methodologies, and test protocols that FDA uses to evaluate nanotechnology in FDAregulated products.

19 Moreover, the CORES program has increased collaboration 

across FDA and continues to strengthen the Agency’s relationship with academia, 

industry, and other federal agencies.

C. Supporting Nanotechnology-related Staff Training and Professional Development 

To keep pace with the extraordinary breakthroughs in product development resulting 

from nanotechnology, FDA requires highly skilled scientific and technical experts. To 

address these rapidly evolving regulatory science needs and help ensure FDA experts

are prepared to address new regulatory challenges, the Agency developed and 

continues to sponsor nanotechnology-specific trainings.

Since nanotechnology has potential applications in all FDA-regulated product areas and 

the Agency is tasked with regulating this emerging technology under several different 

regulatory frameworks, FDA developed an Introduction to Nanotechnology Science and 

Regulation course. This course introduced FDA professionals to the basic science of 

nanotechnology and applications of nanotechnology in FDA-regulated products. 

Following this introductory course, FDA offered the Applied Sciences Course in 

Nanotechnology that addresses: 1) characterization and manufacturing; and 2) safety 

and toxicology. 

These in-depth trainings highlighted the diversity of nanomaterials that have the 

potential to be used in FDA-regulated products; gave a wide-ranging overview of 

manufacturing and analytical techniques; explored current safety and toxicity testing 

assays; analyzed effects that dosimetrics and physicochemical properties have on 

toxicity; and discussed the impacts of routes of exposure.

Another critical training is the annual NTF-sponsored Hands-on Nanotechnology 

Training, which provides basic training at the two nanotechnology core facilities 

(Arkansas and Maryland) for scientists and reviewers tasked with evaluating product 

submissions that involve nanotechnology. This course evaluates different classes of 

 18 https://www.nano.gov/sites/default/files/pub_resource/2016-nni-strategic-plan.pdf

19 Riaz Ahmed KB et al. Silver nanoparticles: Significance of physicochemical properties and in vitro 

studies in toxicological risk assessment. Toxicology In Vitro 38, 2017.
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nanomaterials and offers hands-on training with the common tools used for 

nanomaterial physicochemical characterization. It teaches scientists and reviewers the 

strengths and weaknesses of each method when considering a dataset submitted to 

FDA in support of a product application. 

To keep up with preclinical product development in nanotechnology, the Hands-on 

Nanotechnology Training also includes advanced lectures on innovations in FDAregulated product areas, such as new drugs, generic drugs, and medical devices. 

These advanced lectures integrate relevant case studies using real-world examples that 

provide information on factors that influence biocompatibility, methods to evaluate and 

measure biocompatibility through fractionation techniques, hyphenated methods, and 

surface analytical tools. Since its inception in 2012, more than 120 research scientists

and reviewers from across FDA have been trained through this program.

Additionally, individual FDA product centers have sponsored training for their scientists 

and product reviewers to ensure that experts are aware of advances in the field of 

nanotechnology. For example, in 2013 CDER sponsored discipline-specific training for 

their professionals involved in the review of drug products containing nanomaterials. 

Additional trainings have also included review- or method-specific training. These 

trainings are often held in collaboration with the NTF, so that advances in technology, 

including analytical techniques, can be shared broadly with FDA reviewers in a timely 

manner (example: Lab-based training for particle sizing technique 2017).

In addition to developing internal trainings for FDA scientists and reviewers, FDA has 

supported training developed by external partners, such as the Nanotechnology 

Characterization Laboratory (NCL) at the National Cancer Institute (NCI). In 2004, FDA 

partnered with the National Institute of Standards and Technology (NIST) and NCI to 

establish NCL to perform multidisciplinary testing for cancer therapies, which is vital to 

the clinical translation of nanomedicine candidates. NCL offered a Lessons Learned 

Workshop at FDA describing their experience with different nanomaterial-containing 

products for cancer therapy in 2011. FDA has also given staff training through seminars 

by external/academic experts on emerging topics of interest in nanotechnology.

V. Collaborating with Federal Agencies, Academic Institutions, and 

International Partners 

The 2007 NTF report called for promoting and participating in collaborative efforts to 

further the understanding of biological interactions of nanoscale materials and to 

explore opportunities to enable innovation using nanoscale materials to develop safe 

and effective products under FDA’s regulatory jurisdiction. FDA works collaboratively 

with a wide variety of partners – including other federal agencies, academic institutions, 

and international regulatory partners – to build regulatory science knowledge, effectively 

leverage resources, facilitate innovation, and coordinate policy to fulfill FDA's mission to 

safeguard the public's health.
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A. Domestic and International Coordination 

FDA actively participated in the White House Emerging Technologies Interagency 

Policy Coordination Committee (ETIPC), a U.S. government group charged with 

developing and coordinating cross-cutting policies associated with emerging 

technologies. FDA formulated and issued its science-based policy approach to 

nanotechnology products in coordination with federal partners and consistent with 

federal policy. FDA also worked actively to promote regulatory cooperation in 

international forums, such as in bilateral and multilateral trade forums, international 

organizations, and regulator-to-regulator discussions, to enhance understanding of the 

U.S. science- and risk-based regulatory approach to ensure the safety of 

nanotechnology products and, to the extent feasible, facilitate regulatory alignment. 

FDA is a member of the National Nanotechnology Initiative (NNI),

20 and interacts with 

other U.S. government agencies through participation in the Nanoscale Science, 

Engineering and Technology (NSET) Subcommittee and the Nanotechnology 

Environmental and Health Implications (NEHI) working group. These meetings convene 

scientists from NNI agencies to discuss ongoing nanotechnology research, research 

strategies, priorities, challenges and collaborations, nanotechnology signature 

initiatives, funding, and domestic and international engagement. FDA, along with other 

agencies, submits an annual report to NNI, including significant accomplishments, 

budget, and policy updates. 

Examples of the activities FDA is engaged in through NNI include:

• Participating in the U.S.−E.U. Communities of Research (CoR),

21 established to 

bring researchers together to exchange information and foster potential 

collaborations. FDA experts currently serve as co-chairs of the Characterization 

CoR and the Nanomedicine CoR. These engagements resulted in collaborative 

consensus standards development and helped facilitate regulatory science

discussions on a variety of nanotechnology topics.

• Working with the National Institute of Standards and Technology (NIST) and

European Commission/Joint Research Center (JRC) to co-develop standards for 

regulatory purposes. FDA laboratories also participate in international interlaboratory studies on reference material standards developed at the JRC.

• Participating in the U.S.−India Emerging Materials and Manufacturing Sciences 

working group discussions led by the Office of Science and Technology Policy

(OSTP) in the Executive Office of the President (EOP) in 2016. Subsequent 

collaborative work led by FDA resulted in the Indo-U.S. Science and Technology 

Forum-sponsored Symposium on Nanotechnology Regulatory Science, held in 

Hyderabad, India, in February 2018. The symposium was attended by many 

scientists from the U.S. and Indian government agencies. It provided a venue to 

 20 See: http://www.nano.gov/

21 See: https://us-eu.org/communities-of-research
Nanotechnology – A Decade of Progress and Innovation: 

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16

discuss research, guidance, and policy issues and to identify topics of mutual 

interest for future interactions.

FDA also issues annual reports as part of the President’s budget supplement for 

Nanotechnology, which is coordinated through the National Nanotechnology 

Coordination Office.

22 These annual reports list FDA’s nanotechnology budget and 

major research and regulatory science achievements. FDA’s cumulative investment in 

nanotechnology research since 2009 exceeds $133 million, as captured in Figure 3. It

has helped FDA address emerging challenges in nanotechnology science and policy 

and inform important science-based regulatory decisions.23

Figure 3: Nanotechnology budget at FDA

Examples of how FDA collaborates with other federal agencies and academia on

nanotechnology research include:

• In 2004, FDA, NCI, and NIST, entered into a Memorandum of Understanding

(MoU) to establish the Nanotechnology Characterization Laboratory (NCL) at 

NCI. The goal was to develop standardized assays for nanomaterial assessment 

and to support preclinical characterization of nanomaterial intended for medical 

applications.

24 Through this partnership, NCL generated more than 40 assays 

that have been standardized and reviewed by FDA scientists. This MoU was

renewed in 2015 and in 2020 so that FDA continues to receive data generated by 

the NCL to support regulatory decision-making.

• FDA established a collaboration with the Consumer Protection Safety 

Commission (CPSC) to conduct nanotechnology research on topics of mutual 

 22 See: http://www.nano.gov/about-nni/nnco

23 See: http://nanodashboard.nano.gov/data/NNI_Investments_by_Agency_PCA_2001_2018.xlsx 24 See: https://ncl.cancer.gov/resources/assay-cascade-protocols

0.0

2.0

4.0

6.0

8.0

10.0

12.0

14.0

16.0

18.0

2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020

Budget in Millions of US $

Year

FDA Budget for Nanotechnology
Nanotechnology – A Decade of Progress and Innovation: 

A Report by the U.S. Food and Drug Administration

17

interest that include a project on food-contact material, the leaching potential of 

nanomaterial through laboratory research, and the development of models to 

understand potential exposure.

• CDER and CDRH have both collaborated with the Defense Advanced Research 

Projects Agency (DARPA) and the Defense Threat Reduction Agency (DTRA) in 

their nanotechnology programs. The collaboration includes providing regulatory 

expertise to DARPA or DTRA program managers, drafting calls for proposals, 

serving on review panels, and participating in technical committees.

• In 2015, the United States Pharmacopeia (USP) began organizing efforts 

involving drug products that contained nanomaterials, which had two major 

results: 1) an International Pharmaceutical Federation/USP workshop that was 

held in 2016 and 2) the formation of the Nanotechnology Joint Subcommittee. 

The sub-committee is held jointly within the USP Expert Committees on Dosage 

Forms and the Expert Committee on Physical Analysis and includes CDER and 

CVM representatives. The subcommittee defines nanomaterials currently found 

in applications in pharmaceutical products in the U.S. and identifies analytical 

technology being used to characterize and control manufactured products that 

contain nanomaterials.

• NCTR organizes an annual Nanotechnology for Healthcare Conference in 

collaboration with Arkansas universities, the Arkansas Research Alliance, and 

Winthrop Rockefeller Institute.25 This conference brings together FDA scientists, 

faculty, and students from Arkansas universities, and other national and 

international experts to discuss developments in the diagnosis and treatment of 

human disease using nanotechnology.

FDA interacts with regulatory bodies worldwide to stay current with product 

development occurring outside the U.S., since these products may be submitted to FDA 

for review and approval. In this context, informing regulators from other countries about 

FDA’s experience in nanotechnology regulatory science, capacity-building, and 

developing consensus can assist in advancing the responsible development of 

nanotechnology-based products. Recently, the focus of FDA’s international interactions

with regulators has been to communicate on our standards activities, which are critical 

to ensuring quality for FDA-regulated products. In nanotechnology, FDA’s primary 

outreach is through Nanotechnology Working Groups at the International 

Pharmaceutical Regulators Programme (IPRP) and the Global Summit in Regulatory 

Science (GSRS).

The IPRP Nanotechnology Working group is tasked with mapping activities (e.g. formal 

identification of processes and products across regions) for generic products and 

general critical quality attributes of drug products containing nanomaterials. The

group’s work was instrumental in facilitating the efforts of FDA scientists to lead a 

Nanotechnology Regulatory Research Training in 2018 to Health Canada and to 

Canadian Food Inspection Agency reviewers and scientists. 

 25 See: http://rockefellerinstitute.org/blog/index.php/institute-programs/nano
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The GSRS offers a platform where regulators, policy-makers, and scientists from 

various countries can exchange views on harmonizing strategy and determining how 

innovative methodologies can be developed for, applied to, and implemented into 

regulatory assessments via global collaboration.26 In 2016, a GSRS on Nanotechnology 

Standards and Applications was held in Bethesda, Maryland. The 2016 GSRS brought 

together regulatory, standards, and research experts from 19 countries to discuss 

innovative research and regulatory models, and to identify the reference material and 

documentary standards (e.g. guides, test methods) needed to advance science and 

regulatory review.

27

Outcomes of the 2016 GSRS led to the development of standards priorities in 

nanomaterial containing drugs, devices, food, and personal care products. Since the 

summit, this coalition has been partnering with consensus standard development 

organizations to either develop new standards or update their current documentary 

standards to reflect current advances in nanotechnology.

As well as meeting with sponsors during a specific product submission, FDA engages 

industry on nanotechnology-related issues by participating in, presenting at, and 

organizing public conferences, workshops, and symposia. FDA often discusses draft 

and final guidance for industry at these public meetings to share FDA’s current thinking. 

FDA also actively engages with industry stakeholders through standards development 

organizations (SDOs), such as the International Organization for Standardization

Technical Committee 229 Nanotechnologies (ISO TC/229), American Society for 

Testing and Materials Committee E56 on Nanotechnology (ASTM E56), the 

Organization for Economic Cooperation and Development (OECD Working Party on 

Manufacturing Nanomaterial), where FDA and industry collaborate on developing

consensus standards. In addition to these interactions, several FDA representatives 

participated in the International Life Sciences Institute’s effort to summarize the state of 

the art of nanotechnology applications in food, which concluded with findings published

in several scientific articles.

28

Overall, domestic and international coordination enables FDA to leverage resources

and other entities’ work, helping to prevent redundant research, track advancements in 

the nanotechnology field, and collaborate on shared priorities to advance scientific 

understanding of nanotechnology applications in FDA-regulated products. FDA’s 

engagement in domestic and international forums facilitates an open dialogue with 

regulated industry and FDA’s regulatory counterparts. This promotes a shared 

 26 See: 

https://www.fda.gov/AboutFDA/CentersOffices/OC/OfficeofScientificandMedicalPrograms/NCTR/WhatWe

Do/ucm289679.htm

27 See: https://www.astm.org/COMMIT/GSRS16%20Final%20Report.pdf

28 https://onlinelibrary.wiley.com/doi/10.1002/wnan.1333 and 

 https://onlinelibrary.wiley.com/doi/full/10.1111/1541-4337.12077
Nanotechnology – A Decade of Progress and Innovation: 

A Report by the U.S. Food and Drug Administration

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understanding of the state of the science to ensure that the Agency and the nation are

prepared to address this rapidly evolving field.

B. Providing Leadership in International Standards Development 

Standards are an invaluable resource for both industry and FDA staff. For decades, 

FDA has supported the development and use of national and international documentary 

standards in support of the Agency’s mission to protect and promote the public health. 

The use of standards can increase predictability, streamline premarket review, and 

facilitate market entry and use of safe and effective products.

As FDA’s understanding of how nanotechnology applications are or may be used in 

FDA-regulated products has grown, we have also increased our participation in 

standards development organizations, such as ISO TC/229 and ASTM E56. To 

effectively coordinate this work across all FDA centers, the NTF established the 

Nanotechnology Standards Subcommittee in 2016 with the goals of: 

1) consolidating and coordinating FDA comments for nanotechnology standards 

being considered for review;

2) prioritizing nanotechnology standards based on Agency needs; and

3) assisting in the development of standards. 

The Subcommittee includes members from all FDA centers with interest in 

nanotechnology and facilitates a coordinated and consistent review process for 

documentary standards under development. To date, the Subcommittee has reviewed 

and provided comments on more than 55 consensus work items that were being 

developed by industry and government stakeholders as documentary standards.

Moreover, to further FDA’s regulatory priorities and needs, some FDA centers have 

begun to identify a prioritized list of standards needs through interaction with other 

regulatory agencies. Some of these standards, where FDA has expertise, interest, and 

need, are being developed with stakeholder involvement through SDOs and NTP 

support.

To date, nine FDA-generated work items are going through the consensus process

through SDOs in collaboration with stakeholders and experts. Two work items that FDA 

was heavily engaged in during development were, 1) Standard Practice for Performing 

Cryo-Transmission Electron Microscopy of Liposomes, and 2) Standard Test Method for 

Quantitative Measurement of the Chemoattractant Capacity of a Nanoparticulate 

Material in vitro, which became standards and are available through ASTM 

International.

29 These standards on high-priority areas, such as characterization 

methods to ascertain reproducibility and safety, ultimately provide common ground for 

industry and FDA to help facilitate the development of products containing 

nanomaterials. 

 29 See: https://www.astm.org/Standards/E3143.htm
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FDA also actively assesses the impact of published consensus nanotechnology 

standards on the premarket review process and recognizes these standards, as 

appropriate. The list of such recognized standards by CDRH is published in the Federal 

Register and is searchable on FDA's website30 (select “nanotechnology” under 

“Specialty Task Group Area” to search for recognized nanotechnology standards).

VI. Future Perspectives 

FDA will continue to monitor scientific and technological advancements in products that 

involve the application of nanotechnology. The next generation of nanotechnologyenabled products may involve a convergence of technologies, such as nanotechnology 

and modern molecular techniques and 3D printing of devices containing nanofeatures 

and nanomaterials, which would potentially result in increasing complexity and diversity 

of products and their uses.

Nanotechnology is already incorporated into various products and is likely to be used 

even more in the future. We recognize that, for FDA to achieve its mission of protecting 

and promoting public health, we must be prepared and understand the science behind 

such emerging products. FDA will rely on a combination of horizon-scanning activities 

to stay abreast of new developments and product applications, including by:

• participating in scientific and trade forums;

• participating in standards development;

• continuing discussions with national and international counterparts;

• monitoring scientific and trade literature;

• engaging with academia and developers; and

• performing prospective regulatory science on emerging technologies.

In addition, FDA’s Emerging Sciences Working Group, a cross-Agency, science-based 

forum established in 2016, continues to identify science and technology trends of 

relevance to FDA’s regulatory responsibilities, including those for nanotechnology 

products. FDA’s science-based, product-focused regulatory framework is sufficiently 

flexible and robust to help ensure product safety (and effectiveness, as applicable) while 

supporting innovation for the development of beneficial nanotechnology products. 

 30 See: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm
Nanotechnology – A Decade of Progress and Innovation: 

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VII. Appendix: FDA Nanotechnology Core Facility and Advanced 

Characterization Facility Equipment List 

Nanotechnology Core Facility, Jefferson Laboratories, Arkansas

An NCTR, ORA, and NIEHS/NTP collaboration to support regulatory science research

Nanocore equipment:

Electron Microscopy

• JEOL 2100 Transmission Electron Microscope (TEM) with EDS detector (STEM)

• JEOL 1400 TEM with EDS detector

• Two Zeiss MERLIN Scanning Electron Microscopes (SEM)

o Unit #1 Equipped with two EDAX EDS detectors (30-mm2 chip) and one EDAX 

WDS detector for elemental analysis/mapping

o Unit #2 Equipped with optional Gatan 3View2XP (in-situ ultra-microtome) to achieve 

3D reconstructions of large volumes of soft matter

• JEOL JSM 6610LV SEM with EDS detector

• Delong America Low Voltage Electron Microscope (LVEM25)

Atomic and Optical Microscopy

• Asylum Research MFP-3D Atomic Force Microscope (AFM)

• Veeco diCaliber Scanning Probe Microscope

• Nikon Eclipse Ti-U Inverted Microscope with Epifluorescence Illuminator

• Horiba-Jobin-Yvon Confocal LabRaman-HR Microscope with Raman and FTIR detection

• CytoViva Darkfield Hyperspectral Imaging System

• CytoViva Brightfield Hyperspectral Imaging System

Spectroscopy

• Perkin-Elmer Lambda 45 UV-Vis Spectrophotometer

• Perkin-Elmer LS 55 Fluorescence Spectrometer

• Perkin-Elmer Spectrum 400 Infrared Spectrometer

• PicoQuant FluoTime 200 High Performance Fluorescence Lifetime Spectrometer

• Beacon 2000 Variable Temperature Fluorescence Polarization System 

• NS3 Raman, Fluorescence and Absorption for Singl-Walled Carbon Nanotube Analysis
Nanotechnology – A Decade of Progress and Innovation: 

A Report by the U.S. Food and Drug Administration

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Particle Size Analysis and Characterization

• Malvern Zetasizer Nano ZS

• Malvern Mastersizer 3000

• Two Nanosight LM-10HS Nanoparticle Tracking Analyzer with red or green/blue laser 

modules

• Sympatec NanoPhox Photon Cross Correlation Detector

• Brookhaven ZetaPALS Zeta Potential and Particle Size Analyzer

• Izon QNano

• Beckman Coulter Surface Area and Pore Size Analyzer SA3100 

• Quantachrome Instruments Autosorb iQ2 Automated Gas Sorption Analyzer

Elemental Analysis

• Thermo Scientific X Series 2 Inductively Coupled Plasma-Mass Spectrometer (ICP-MS) 

equipped with a New Wave Instruments UP-213 UV laser ablation sampling system

• Two Agilent 7700-X ICP-MS; stand-alone or coupled to a high-performance liquid 

chromatography or capillary electrophoresis system

• Agilent QQQ ICP-MS

• Perkin Elmer ICP-MS

• CEM MARS-Xpress Microwave Accelerated Reaction System (n=3)

• CEM Discover SP-D Microwave Digestion System 

• Rigaku X-ray Fluorescence (XRF) Primus II Analyzer

• Innov-X 5000 Portable XRF Analyzer

• Bruker D2 Phaser X-ray Diffraction System

Instrumentation for Separation/Fractionation

• Agilent 7100 Capillary Electrophoresis System

• Two Agilent 1260 Infinity Binary Pump High Performance Liquid Chromatography (HPLC) 

Systems with fraction collector, diode array UV-visible detector, and fluorescence 

detector, Refractive Index detector, Evaporative Light Scattering and Charged Aerosol 

detectors. 

• Waters Ultrahigh Performance Liquid Chromatography QQQ Mass Spectrometer (UPLCMS)

• Two Wyatt Technology Eclipse 3+ Asymmetric Flow-Field-Flow Fractionation (AFFF) 

System with Dawn Heleos--II multi-angle light scattering detector (and Optilab T-rEX 

refractive index detector

• GE Fast Protein Liquid Chromatography system (FPLC)

• Postnova Centrifugal Flow Field Flow Fractionation system with MALLS and UV-Vis 

detectors

• CPS Disc Centrifuge system
Nanotechnology – A Decade of Progress and Innovation: 

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Additional Equipment

• CH Instruments 630D Electrochemical Analyzer

• Cambridge VISCOpro 2000 Viscometer

• DNA SpeedVac Concentrator/Evaporator

• Qiagen Tissue Lyser (n=2)

• Thermo Scientific Sorvall WX Ultracentrifuge 

• BioTek Synergy 2 Micro-plate Reader

• CEM Discover SP/Explorer Hybrid Synthesis System

• TSI Electrospray Aerosol Generator/Aerosol Sampler

Advanced Characterization Facility, FDA Headquarters, Maryland

A collaboration between CDRH, CDER, CBER, and CFSAN to support 

regulatory science research

Advanced Characterization Facility Equipment 

• Transmission Electron Microscopy (TEM)

• Scanning Electron Microscopy (SEM)

• Atomic Force Microscopy (AFM)

• Inductive Coupled Plasma Mass Spectrometry (ICP-MS)

• Laser Ablation system

• Ion Chromatography

• TEM Grid Glow Discharger

• Turbo Pumped Sputter Coater

• TEM Grid Plunger Freezer

• Ultramicrotome

• Microwave tissue embedding processor

• Microwave digestion system

• Dynamic Light Scattering and Zeta Analyzer

• Nanosight Particle Analyzer

• qNano Tunable Resistive Pulse Sensing Particle Analyzer
1

U.S. Department of Health and Human Services 

Food and Drug Administration

Office of the Commissioner

Office of the Chief Scientist

Issued July 2020