Press Release.

FOR IMMEDIATE RELEASE

Contact: Mike Duff
(703) 647-6214
mduff@alssa.org

 

ALSSA Comments on FDA’s “Research Use Only” Product Guidelines

 

Alexandria, VA (August 29, 2011) — At the request of several member companies, ALSSA has filed written comments in response to a "draft" guidance document issued earlier this Summer by the US Food and Drug Administration. The draft guidance would apply to in vitro diagnostic ("IVD") "research use only" and "investigational use only" products.

Background: Products sold to clinical laboratories may be exempted from the FDA's pre-market notification and approval process if they are used for "research use only" purposes. In its draft document, FDA indicated it is concerned that some "research use only" products are being used in clinical diagnostic applications, and that the manufacturer of the product often knows or should know of the actual use of its products.

FDA’s Proposal: Among other things, the draft guidance prescribed certain labeling requirements, and also indicates that FDA will look at how the products are labeled, advertised and used, and whether the device manufacturer has knowledge that their product is used for a purpose which conflicts with the labeling. The draft guidance further suggests that manufacturers which label their products for "research use only" should not sell those products to labs they know will use the products for clinical diagnostic use.

Further, if a manufacturer selling a "research use only" product learns that a lab is using the product in clinical diagnosis, the guidance indicates the manufacturer should halt such sales or comply with the FDA requirements for IVD products including premarket notifications and approval if applicable.

ALSSA’s Comments: A group of ALSSA members working with legal counsel outlined several concerns that were expressed in ALSSA’s comments, including:

  • FDA’s current proposal is a significant departure from the three previous Research Use Only drafts, none of which were adopted.
  • The draft guidance would change FDA's policy that “intended use” is based on what is intended by the manufacturer as opposed to the user’s actual uses.
  • Halting future sales based on as few as a single sale would be a departure from FDA's policy.
  • The draft would change the definition of “research” and limit it to that which is novel and fundamental.
  • There is no "grandfather" provision and the draft if implemented in its current form could have a harmful effect on the development of new diagnostic technologies.

 

For more information regarding ALSSA and its comments to FDA, contact Mike Duff, President of ALSSA, at 703-647-6214. More information regarding ALSSA can be found at www.alssa.org.

ALSSA is the primary trade association for companies that develop and market technologies and solutions that enable scientific discoveries worldwide and applications which benefit society and lead to advances in healthcare, industrial innovation, and a safe and clean environment.

ALSSA members provide the “tools” and “solutions” essential to conduct research, testing, discovery and product development in a wide range of industries and applications including:

  • Pharmaceuticals and Drug Discovery
  • University and Scientific Research
  • Biotechnology
  • Forensics
  • Chemicals and Chemical Processing
  • Molecular Diagnostics Testing
  • Food Safety
  • Environmental Testing
  • Medical and Life Science Research

# # #
Press

Join ALSSA Today - Click here for more information.

“ALSSA membership offers a great opportunity to maintain relationships with fellow industry executives, as well develop new ones. The meetings offer a unique forum for exchange of information on markets, technologies and emerging companies, as well as regional trends. I have been involved in ALSSA with several companies and we have consistently realized value from our participation.”

Frank Witney
President & CEO
Affymetrix, Inc.