We’ve blogged several times about the Biomaterials Access Assurance Act of 1998, 21 U.S.C. §§1601-06. In a nutshell, the BAAA provides suppliers of “raw materials and component parts” used in the manufacture of medical devices with a “Get Out of Litigation Free” card in most situations. It allows manufacturers of “biomaterials” – defined as “a manufactured piece of an implant” or a “substance” that “has a generic use” and “may be used in an application other than an implant” – to remove themselves from product liability litigation before being forced to engage in expensive and time consuming discovery. See 21 U.S.C. §1602(3, 8) (defining “raw material” and “component part”).
However, the BAAA is now twenty years old, and in light of the rapid technological advancement in the medical device field, could use some updating for the twenty-first century.
What Congress was trying to ensure in enacting the BAAA was that manufacturers of “raw materials and component parts [that] also are used in a variety of nonmedical products” remain willing to supply manufacturers of medical devices by removing the threat of litigation over the small quantity of those materials used by medical device manufacturers to make FDA-regulated products:
(5) because small quantities of the raw materials and component parts are used for medical devices, sales of raw materials and component parts for medical devices constitute an extremely small portion of the overall market for the raw materials and component parts;
(6) under the [FDCA] manufacturers of medical devices are required to demonstrate that the medical devices are safe and effective, including demonstrating that the products are properly designed and have adequate warnings or instructions;
(7) notwithstanding the fact that raw materials and component parts suppliers do not design, produce, or test a final medical device, the suppliers have been the subject of actions alleging inadequate–
(A) design and testing of medical devices manufactured with materials or parts supplied by the suppliers; or
(B) warnings related to the use of such medical devices;
(8) even though suppliers of raw materials and component parts have very rarely been held liable in such actions, such suppliers have ceased supplying certain raw materials and component parts for use in medical devices for a number of reasons, including concerns about the costs of such litigation;
(9) unless alternate sources of supply can be found, the unavailability of raw materials and component parts for medical devices will lead to unavailability of lifesaving and life-enhancing medical devices. . . .
Back in 1998, few if any medical devices utilized computer software, and cloud computing did not exist. Further, to the extent that software was used in medical devices twenty years ago, it was not “agnostic,” but rather invariably custom made for the particular device – in stark contrast with the widespread use of interoperable imaging and 3D printing technology (to name two) in current medical devices. Not surprisingly, the protection of the 1998 BAAA was limited to physical materials. “Component parts” are “manufactured piece[s].” Id. §1602(3)(a). A “raw material” is “a substance or product.” Id. §1602(8).
Thus, our proposal here is simple. In order for the BAAA to provide the scope of protection for suppliers of database agnostic software and platform agnostic storage capacity (and other types of interoperable computer code that we mere bloggers don’t even comprehend – blockchain, anyone?) as Congress intended, the BAAA needs to be amended to include manufacturers of a third category of medical device-related inputs, “electronic applications” (or something like that), within its protections. To that end we propose the following amendment, in the nature of an addition, to §1602. First, to add a new definition:
(3A) Electronic applications
The term “electronic applications” means electronic software, data storage and other interoperable processing of electronic data used in connection with a medical device that has significant non-device-related uses.
Next, we advocate inclusion of “electronic applications” in the definition of “biomaterials supplier” provided in §1602(1).
These additions may require some tweaks elsewhere in the BAAA, but the gist of our proposal should be clear. In the twenty-first century, the ability of a medical device manufacturer to incorporate multi-use “agnostic” electronic programming into its devices will be at least as important as access to specialized plastics and alloys was in the twentieth century. To ensure that vendors of such data processing software, cloud storage, and other interoperable electronic coding will continue to deal with medical device manufacturers without fear of (or prohibitive price premiums for) involvement in protracted, multi-district mass tort litigation, the BAA needs to be amended to include electronic software as twenty-first century biomaterials.