A Solution in Search of a Problem: Safety of Untested and New Devices Act of 2012

By Jennifer D. Newberger –

On January 31, 2012, Rep. Edward Markey (D-MA) introduced H.R. 3847, the “Safety of Untested and New Devices Act of 2012,” also known as the “SOUND Devices Act of 2012.”  The bill attempts to limit the body of devices that may be available for use as predicates.  The key provisions include:

• Submitters of 510(k) notifications would be required to include information about the history of corrections and removals of the predicate device and the predicates of that predicate; 
• FDA may reject a claim of substantial equivalence if the predicate device or its predicates were corrected or removed, or if FDA is in the process of taking regulatory action against the predicate or its predicates, due to an “intrinsic flaw in technology or design that adversely affects safety”;
• FDA may reject a claim of substantial equivalence if the predicate was corrected or removed and the manufacturer failed to report such correction or removal; and
• When a device is corrected or removed because of an intrinsic flaw in technology or design that adverse affects safety, FDA may order manufacturers of devices “in the same lineage” to submit a report stating whether their device shares the same intrinsic flaw, and if not, why not.

The underlying assumption reflected in the bill seems to be that sponsors are rampantly foisting badly designed devices on the public, that they refuse to improve their devices to correct known problems, and that FDA does not now have sufficient statutory authority to prevent the proliferation of badly designed devices. 

This assumption is not based in reality.  If one thinks back to the commonly used medical devices in use 20 years ago, or even 10 years ago, there has been continuous and sometimes dramatic improvement in quality of the design and technology of a wide range of devices.  Furthermore, FDA has ample authority to ensure the quality of the devices cleared through the 510(k) process, and it frequently exercises it.  Hence, the title of this blog post – this bill is truly a solution in search of a problem.

Turning to the provisions of the bill, certain of these proposals would be nearly impossible for sponsors to meet, while others would give FDA authority to prohibit a large number of devices from serving as predicate devices, limiting the use of the 510(k) program as a viable option for marketing devices.  As noted, all of this drama would be inflicted on the device industry for very little gain in patient health or safety.

Submission of Predicate Information.  The bill would require sponsors to provide information to FDA in a 510(k) submission on the “market status” of each predicate device and “each device in the full device lineage.”  The information to be provided includes information about whether the device has been corrected or removed from the market, the basis for such correction or removal, “including whether such correction or removal was because of an intrinsic flaw in technology or design that adversely affects safety,” and why the proposed device does not share “any such intrinsic flaw.”  Of course, all of these concepts are highly subjective and likely to engender years of disputes between FDA and industry. 

Also, the question of whether the device has been corrected or removed is not time-limited.  A strict reading of the bill language indicates that the question is whether the predicate (or its predicate) was ever corrected or removed.  Note also that this is not limited to reportable corrections or removals, e.g., Class I or Class II recalls, meaning that a sponsor would need to submit information related to Class III recalls, even though that information is generally not required to be reported to FDA.  It is not explained how the sponsor will be able to gather information that is not publicly available.

A “device in the full device lineage” is a “device for which a substantial equivalence determination was made leading to a substantial equivalence determination for a predicate device” used in a new submission.  So this means that a sponsor needs to provide market information not only on the predicate device, but on any device that served as a predicate to the predicate.  In the case of a device that cites multiple predicates, the sponsor presumably will need to provide a complete family tree for each of the predicates.

“Intrinsic flaw in technology or design that adversely affects safety.”  Currently, the Federal Food, Drug, and Cosmetic Act ("FDC Act") prohibits a finding of substantial equivalence to a predicate that was removed from the market at the initiative of FDA or was determined to be misbranded or adulterated by a judicial order.  (Both FDA-mandated recalls and judicial orders of this nature are exceedingly rare.)  In addition to these criteria, the bill would permit FDA to reject a claim of substantial equivalence to any predicate (or predicate’s predicate) corrected or removed from the market at the initiative of the sponsor and the correction or removal “is due, in whole or in part, to an intrinsic flaw in technology or design that adversely affects safety.”  The bill fails to address the obvious point that a correction or removal is typically conducted in order to modify a device to address a problem in design or manufacturing.  So, if the predicate device was, in fact, modified to address a design problem, what is the impact of the modification on the requirements of this bill?  If the modification was cleared through the 510(k) process, presumably the sponsor can simply claim substantial equivalence to the post recall 510(k) clearance and avoid this bill altogether.

FDA may also reject a claim of substantial equivalence to a predicate if FDA is undertaking any regulatory action (e.g., trying to rescind clearance, issuing a recall order) to remove the predicate, or the predicate’s predicate, from the market “because of an intrinsic flaw in technology or design that adversely affects safety.”  This means that, without considering whether the proposed device introduces modified technology or design that could remedy the problems associated with the predicate, FDA may reject a claim of substantial equivalence based solely on the safety issues of the predicate. 

Failure of predicate manufacturer to submit required report of correction or removal.  The most broad-reaching of the new authorities would permit FDA to reject a claim of substantial equivalence to a predicate “if the predicate device has been corrected or removed from the market and the manufacturer or importer of the predicate failed to submit” the required notice of such correction or removal.  Under this provision, the sins of the father would indeed be visited upon the sons.

Shared intrinsic flaw.  When a device is corrected or removed from the market because of an intrinsic flaw in technology or design that adversely affects safety, the bill would allow FDA to order a manufacturer or importer of a marketed “device in the same lineage” to submit a report stating whether the marketed device shared any intrinsic flaw, and, if not, to explain why the device does not share the flaw.

Congress, industry, and FDA should all consider how to best assure that marketed devices are as safe as they possibly can be.  This bill, however, does nothing to further that goal, and it should not be taken seriously.