Small Regulation: FDA Adopts Three Nanotechnology Standards in Last Year

Posted 10 February 2015 | By Alexander Gaffney, RAC 

Small Regulation: FDA Adopts Three Nanotechnology Standards in Last Year

The US Food and Drug Administration (FDA) has just adopted a new standard on the use of nanotechnology in medical devices—only its third nanotechnology standard yet adopted.


The new standard, Surface Characterization Of Gold Nanoparticles For Nanomaterial Specific Toxicity Screening: FT-IR Method, was released on 27 January 2015 as part of a major update to FDA's List of Recognized Standards.

The standards adopted by FDA are something of a deviation from normal FDA practices. Under normal circumstances, FDA creates new regulations or guidance documents explaining what companies need to do to create compliant products.

However, the process of creating and releasing a new guidance document or regulation is lengthy, complicated and expensive. To cope, FDA often adopts standards issued by third-party standards-setting groups, which are meant to ensure companies are compliant with best practices for the testing and production of their unique products. This is used especially often in the medical device industry, which features thousands of types of devices, each with their own unique needs.

Since 1998, FDA has released 38 updates to its list of recognized standards. The updates frequently include the addition of brand new standards, updates to existing standards and the retiring of standards which have since become irrelevant.

Three New Standards

But since 30 January 2014, FDA has quietly been releasing recognized consensus standards in a brand-new area: Nanotechnology.

Standard OrganizationStandard DesignationStandard TitleAdopted by FDA
ASTME2490 - 09Standard Guide For Measurement Of Particle Size Distribution Of Nanomaterials In Suspension By Photon Correlation Spectroscopy (PCS)01/30/2014
ASTME2535-07 (Reapproved 2013)Standard Guide For Handling Unbound Engineered Nanoscale Particles In Occupational Settings07/09/2014
ISO/TS 14101 First Edition 2012-11-01Surface Characterization Of Gold Nanoparticles For Nanomaterial Specific Toxicity Screening: FT-IR Method01/27/2015


The three standards released to date all relate to different areas of nanotechnology. A standard developed by the International Organization for Standardization (ISO), for example, is meant to affect "all medical devices or their manufacturing processes involving gold nanoparticles that require toxicity screening."

Another standard covers any devices "involving unbound engineered nanoscale particles."

A third, more general, standard meanwhile covers "all medical devices containing materials with particles whose size in at least one dimension is from 1-100nm."

Existing FDA Guidance

All three standards come just months after FDA released a new guidance document, Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology.

As Regulatory Focus explained at the time, FDA's nanotechnology guidance doesn't delve into specifics, but rather lists several "points to consider" intended to help sponsors of nanotechnology products to successfully file their product.

"FDA is particularly interested in the deliberate and purposeful manipulation and control of dimensions to produce specific properties, because the emergence of these new properties or phenomena may raise questions about the safety, effectiveness, performance, quality or public health impact that may warrant further evaluation," regulators wrote.

The three new standards, then, might well represent FDA's first specific—if indirect—steps toward the regulation of nanotechnology products.


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