By Allyson B. Mullen –
On March 14, in the Federal Register, FDA published a list of Class II devices that the agency proposes exempting from the 510(k) requirements. A copy of the Federal Register notice can be found here. As you may recall from our earlier post, Section 3054 of the 21st Century Cures Act required FDA to publish such a list for public comment. Under this new law, FDA is required to publish such a list once every five years beginning this year.
The proposed list is quite extensive. However, many of the devices on the list are already informally exempt. In 2015, FDA published a final guidance, “Intent to Exempt Certain Unclassified, Class II, and Class I Reserved Medical Devices from Premarket Notification Requirements,” listing numerous unclassified, Class I, and Class II devices that FDA believed qualified for 510(k) exemption. The Class II devices from this final guidance now appear on FDA’s proposed list for public comment. Thus, much of this proposed list is unenlightening.
There are, however, a number of new devices on the list including a large list of in vitro diagnostic (IVD) devices, such as gene expression profiling reagents and DNA genetic analyzers. FDA has also proposed exempting high-throughput genomic sequence analyzer for clinical use. All of these examples are relatively new devices.
Perhaps the most notable proposed exemption, however, relates to drugs of abuse tests. FDA has proposed exempting virtually all drugs-of-abuse testing including those performed by traditional screening methods such as enzyme immunoassay and radioimmunoassay, and newer confirmatory methods such as mass spectrometry and gas chromatography. The proposed exemption includes not just professional use tests, but also some over-the-counter tests.
The proposed exemption for drugs-of-abuse test systems is limited to “test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)”
By regulation, FDA regulates drugs-of-abuse testing devices are intended for use “in the diagnosis and treatment of [drug] use or overdose” (see, e.g., 21 C.F.R. § 862.3250(a) (cocaine and cocaine metabolite test system)) and in some instances “in monitoring levels of [drug] to ensure appropriate therapy” (see, e.g., 21 C.F.R. §§ 862.3150(a) (barbiturate test system), 862.3170(a) (benzodiazepine test system)).
FDA has carved out a narrow exception to regulatory oversight of drugs-of-abuse test systems, in which FDA exercises enforcement discretion over tests used solely for forensic (law enforcement) purposes, “because there are protections to ensure sample integrity and test accuracy that are not generally available in the home, workplace, insurance and sports settings” including the rules of evidence in judicial proceedings.” See 65 Fed. Reg. 18,230, 18,230 (Apr. 7, 2000) (here).
The regulatory scheme for drugs-of-abuse test systems have been a bit of a regulatory mystery for some over the years. Warning letters have asserted that test systems intended for workplace drug testing does not qualify as exempt forensic testing. See, e.g., FDA, Warning Letter to American Bio Medica Corp. (July 30, 2009) (this warning letter also led to a 2013 Consent Decree relating to drugs-of-abuse tests for workplace testing requiring 510(k) clearance); and FDA, Warning Letter to Branan Medical Corp., Inc. (Dec. 28, 2009). FDA’s proposal suggests that the Agency now considers employment and insurance testing to be of sufficiently low risk that they may warrant 510(k) exemption.
The proposed exemption for insurance and employment testing is separate from the forensic testing carve out. One notable difference is that forensic drugs-of-abuse tests are not subject to any FDA regulatory oversight under FDA’s enforcement discretion whereas the new proposal would only exempt workplace and insurance tests from the 510(k) requirements. Workplace and insurance drugs-of-abuse tests (along with manufacturers of other devices on the proposed exemption list) will still be required to comply with all other applicable FDA regulatory requirements, including the design controls, to the extent applicable, MDR reporting, and reporting corrections and removals. Manufacturers of such devices will also continue to be subject to FDA inspections.
If finalized, the exemptions, including the drugs-of-abuse tests would still be subject to the .9 limitations, which requires a manufacturer to obtain 510(k) clearance for an exempt device type, if (i) the device is intended for a use different from the intended use of a legally marketed device in that generic type of device, (ii) the device operates using a different fundamental scientific technology than a legally marketed device in that generic type of device, or (iii) if it falls within a certain category of IVDs. FDA will be accepting comments on the proposed list of devices for 510(k) exemption for the next 60 days.