Originally published January, 1996
CDRH's new compliance policy guide (CPG) for in vitro diagnostic (IVD) devices will provide a 30-month grace period for all manufacturers to collect data and submit them to FDA for review, deputy chief of IVD compliance Betty Collins told attendees of the recent Regulatory Affairs Professionals Society annual meeting in Washington, DC.
The long-awaited new CPG will be released in draft form "in the near future," Collins said. The new document will address concerns FDA has over manufacturers not following the requirements of 21 CFR 812.2(c)(3) when they claim to be exempt from the investigational device exemption (IDE) requirements for IVDs used in research. The CPG replaces the accommodations list in the 1991 draft document, which included 59 procedures FDA considered standard-of-care tests and thus exempt from a certification program, she continued.
Rather than treat her audience to a rundown of what the CPG will include--FDA has been criticized for its "podium policy" pronouncements in informal settings--Collins chose to describe what it will not cover. It will not address home brew or off-label use of modified devices used by clinical laboratories, whether publicly or privately run, she said. "The first draft did try to address home brew and that is where we ran into some problems. We plan to address it in another memorandum of understanding." The CPG also will not address the use of IVDs for forensic applications, or the instrument use of IVDs. "And you don't have to worry about IVDs that have a 510(k), PMA [premarket approval], or an IDE submission in-house," Collins said.
She noted, however, that FDA will consider IVDs labeled for investigational use to be illegally commercialized in the following situations: "If you label your product or promote your product with statements indicating that the device is safe and effective for an intended use prior to agency clearance. [Also t]he dis- tribution of devices, including mail or shipment, to persons not conducting a clinical investigation of one or more subjects for the purpose of determining safety and effectiveness. Keep in mind that FDA does require, before you commercialize or market any of your IVD products, that they be cleared through a 510(k) or PMA before they can be used for diagnostic purposes."
According to Collins, the 30-month grace period was developed because FDA "recognizes that certain unproven commercialized IVDs have been used extensively in the clinical setting for a long period of time, and that some of those have gained credibility in the medical community.... Because of this, rather than remove those IVDs from use, [which] may result in certain adverse health consequences for the public, FDA included the 30-month grace period so that there would be no disruption in the availability of these products."
IVDs ineligible for the 30-month grace period include those used as stand-alone devices that may lead to a significant medical decision; those for which FDA has determined that there are inadequate data available on safe-ty and effectiveness; those for which there are no human diagnostic use data or only anecdotal data, as determined by FDA; and those manufactured by com- panies that do not abide by the conditions for receiving the 30-month grace period. "That is basically truth in labeling," Collins said.
FDA will impose conditions on receiving the 30-month grace period, which she alternatively termed "30 months of enforcement discretion." During this time, Collins said, FDA will use its discretion in going after any manufacturer of any unapproved IVDs. "The only thing the agency will be asking is that you start your clinical trials, if you haven't already. We believe that most companies have been collecting data, but you need to start within six months of the issuance of the CPG. We will be asking firms to immediately desist from using labeling indicating that the IVD is safe and effective--that is, labeling for performance char- acteristics such as specificity, sensitivity, and indication for use when it is for research use. [Manufacturers] should not be able to [suggest] those kinds of performance characteristics."
FDA is asking IVD manufacturers to observe truth in labeling by following 21 CFR 809.10, Collins said. "You would have your products labeled 'For research use only, not for use in diagnostic procedures.' For investigational products, we would be expecting you to have those IVDs labeled 'For investigational use only; the performance characteristics of this product have not been established.'"
James G. Dickinson is a veteran reporter on regulatory affairs in the medical device industry.