Regulatory Focus™ > News Articles > Legislation Seeks to Neuter FDA Draft Guidance on Research-Only IVDs

Legislation Seeks to Neuter FDA Draft Guidance on Research-Only IVDs

Posted 06 August 2013 | By Alexander Gaffney, RAC

A new piece of legislation introduced by a Republican legislator on the House Energy and Commerce (E&C) Committee seeks to amend the Federal Food, Drug and Cosmetic Act (FD&C Act)  to permit medical device companies to sell or otherwise provide access to "research use only" (RUO) diagnostic tests.


RUO products are those that have not been cleared for use in humans by FDA, but may have research applications within a laboratory or other facility.

While FDA's authority to regulate these devices is contested, as some groups claim they would be regulated under the Clinical Laboratory Improvements Act (CLIA) of 1988 and not the FD&C Act, FDA has nevertheless asserted its authority to regulate them under Section 520(g) of the FD&C Act (which permits it to waive investigational requirements ordinarily required of most devices), and in 2011 released a draft guidance document on RUOs and investigational use only (IUO) in vitro diagnostic (IVD) products.

FDA notes in the guidance that the "marketing of unapproved and uncleared IVD products for purposes other than research or investigation has led in some cases to diagnostic use of laboratory tests with unproven performance characteristics and manufacturing controls that are inadequate to ensure consistent manufacturing of the finished product." This unproven use could lead to patient harm in some instances, FDA added.

The guidance goes on to define the necessary qualifications of an RUO/IUO, which must:

  • be non-invasive
  • not require an invasive sampling procedure that presents a significant risk
  • not by design or intention introduce energy into a subject
  • not be used as a diagnostic procedure without confirmation of the diagnosis by another, medically established diagnostic product or procedure
  • be clearly labeled as either RUO or IUO

New Legislation-Limiting FDA's Authority?

A new bill introduced on 2 August 2013 by Rep. Michael Burgess (R-TX), the Medical Testing Availability Act of 2013 (H.R. 3005), would seek to amend Section 520 of the FD&C Act-the same section cited by FDA to regulate the RUO products-to amend the labeling requirements to provide "clarification."

A reading of the bill, however, shows that it would limit FDA's authority while likely making it easier for RUO product manufacturers to sell their products.

Specifically, Section 520 of the FD&C Act would be amended to include a new Section 520(o), which would limit FDA's ability to declare misbranded any RUO product that is either:

  • sold to an end user "who uses the product in a manner inconsistent" with the RUO statement, or
  • marketed-"business communications regarding the product"-to an "end user of the product" regarding its functioning, its proper use, its performance and "other similar contacts."

Under FDA's current guidance, RUO/IUO IVD products may be "marketed for and used in the research and investigation of other products," but that understanding could be muddied if the manufacturer knows that the end user will be using the product for unapproved purposes.

This sentiment is expressed explicitly later in the guidance when FDA states:

In addition to overt expressions by the manufacturer such as those present in labeling and advertising, intended use may be shown by the circumstances surrounding the distribution of the product and the manufacturer's knowledge that its product is offered and used for a purpose for which it is neither labeled nor advertised. For example, FDA may consider a manufacturer's knowledge of the purposes for which its customers offer and use its IVD product, and the manufacturer's provision of technical support for those activities, to be evidence that the IVD product is intended to be used for such purposes. The weight of this evidence will vary with the circumstances.

Burgess' legislation seems to be aimed at this section of the guidance, giving manufacturers leeway to market their products regardless of the eventual use of the product so long as the manufacturer does not explicitly market it as being appropriate for non-research or non-investigational use.

H.R. 3005 has been referred to the House E&C Committee for consideration, and will likely be taken up after the cessation of the August congressional recess.

Medical Testing Availability Act of 2013 (H.R. 3005)

Legislative Language (h/t FDA Law Blog)

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