Posted 14 January 2015
By Alexander Gaffney, RAC
A new bill introduced in the House of Representatives by a prominent Republican legislator would make it easier for companies to distribute investigational medical devices explicitly labeled as being "for research use only (RUO)."
The Medical Testing Availability Act of 2015, sponsored by Rep. Michael Burgess (R-TX), the vice chairman of the Energy and Commerce Committee's Subcommittee on Health, is similar to an identically titled bill introduced by Burgess in 2013.
See our FDA Legislation Tracker for a list of all FDA-related legislation going back to 2012.
The bill seeks to make it easier for companies to distribute their products under RUO settings.
FDA defines RUO products under a 2011 draft guidance document as products that have not been cleared for use in humans by FDA, but may have research applications within a laboratory or other facility.
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 explained.
FDA's guidance relies upon a standard of what it calls "objective intent" to regulate RUO devices. "Intent is determined by such persons’ expressions or may be shown by the circumstances surrounding the distribution of the article." In plain terms: If a company is trying to distribute an RUO device for non-research or non-investigational purposes, FDA can consider the device to be adulterated or misbranded under the Federal Food, Drug and Cosmetic Act (FD&C Act).
RUO devices are also held to several other standards, including that they should be non-invasive, not require invasive sampling, not introduce energy (e.g. electricity) into a subject, not be used to diagnose a subject without confirmation by another cleared device and be clearly labeled as an RUO device.
Read more in FDA's guidance document, Distribution of In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only.
Burgess' new legislation would roll back some of those limits by amending Section 520 of the FD&C Act.
Specifically, the Medical Testing Availability Act of 2015 would prevent FDA from deeming a product as "misbranded" or "adulterated" if the product is sold "to an end user who uses the product in a manner inconsistent with [the labeling]," or if the sponsor of the product "engages in business communications regarding the product with an end user of the product."
As Focus noted in our 2013 analysis of the bill, the legislation seems targeted at FDA's 2011 draft guidance, which reads:
A product’s intended use refers to the “objective intent” of those legally responsible for labeling the product, which may be determined by looking at the totality of circumstances surrounding the distribution of the article. Overt expressions by the manufacturer, such as those present in labeling and advertising, may be sufficient to show determine that an IVD product is in appropriately labeled RUO or IUO (Investigational Use Only), when such expressions demonstrate that the device is actually intended for clinical use despite the RUO or IUO labeling. Other evidence of the intended use of a product could include the design of the product, other statements by the manufacturer about the device, and how the device is sold and distributed by or on behalf of the manufacturer.
The legislation, in other words, would instruct FDA to avoid enforcing its "objective intent" standard and let RUO devices be sold and used more freely—a potential loophole some diagnostic devices could take advantage of to reach the market more quickly.
Burgess' bill has been referred to the Energy and Commerce Committee, and is cosponsored by Rep. Jackie Speier (D-CA).
Medical Testing Availability Act of 2015