What Is the Definition of ''Adulterated Drug'' ?
A drug or device is deemed adulterated under Texas law if it is a class III device under the federal regulations with no premarket approval or pending application for approval for sale. See TEX. HEALTH & SAFETY CODE ANN. 431.111(f)(1).
The Medical Device Amendments of 1976, Pub. L. No. 94-295, 90 Stat. 539 (1976) (codified at 15 U.S.C.A. 55 and in various sections of 21 U.S.C.A.) (MDA), amending the FFDCA, require the FDA to classify medical devices intended for human use into one of three classes: I, II, or III. See 21 U.S.C.A. 360c(b)(1) (West 1999).
A class III medical device is subjected to an extensive and rigorous premarket approval process. See id. 360e (West 1999).
The MDA requires premarket approval for class III medical devices because such devices present "a potential unreasonable risk of illness or injury." Id. 360c(a)(1)(C)(ii)(II).
Once the FDA gives premarket approval, federal regulations prohibit the device from being "manufactured, packaged, stored, labeled, distributed, or advertised in a manner that is inconsistent with any conditions to approval specified in the premarket approval order for the device." 21 C.F.R. 814.80 (1999).
All devices are class III after the effective date of the MDA unless the manufacturer obtains an FDA determination that the device is substantially equivalent to a predicate device that either did not require premarket approval or was classified in class I or II:
A device classified in class III under this paragraph shall be classified in that class until the effective date of an order of the Secretary under paragraph (2) . . . classifying the device in class I or II. 21 U.S.C.A. 360c(f)(1).
Ultrasound devices are classified as class II devices "to provide a visual representation . . . of a fetus, for diagnostic purposes." 21 C.F.R. 884.2225(a), (b) (1999).
Section 431.111(f)(1) provides that "a drug or device shall be deemed to be adulterated . . . if it is a class III device:
(A) (i) that is required by a regulation adopted under Section 515(b) of the federal Act to have an approval under that section of an application for premarket approval and that is not exempt from Section 515 as provided by Section 520(g) of the federal Act 21 U.S.C.A. 360j(g) (West 1999); and
(ii) (I) for which an application for premarket approval or a notice of completion of a product development protocol was not filed with the United States Food and Drug Administration by the 90th day after the date of adoption of the regulation; or
(II) for which that application was filed and approval was denied or withdrawn, for which that notice was filed and was declared incomplete, or for which approval of the device under the protocol was withdrawn;
(B) that was classified under Section 513(f) of the federal Act 21 U.S.C.A. 360c(f) into class III, which under Section 515(a) of the federal Act 21 U.S.C.A. 360e is required to have in effect an approved application for premarket approval, that is not exempt from Section 515 as provided by Section 520(g) of the federal Act and that does not have the application in effect; or
(C) that was classified under Section 520(l) of the federal Act into class III, which under that section is required to have in effect an approved application under Section 515 of the federal Act, and that does not have the application in effect . . . .TEX. HEALTH & SAFETY CODE ANN. 431.111(f)(1).
Federal regulations provide explicit instructions for reclassification of this device. See id. 884.3(b) (1999). First, "any new, not substantially equivalent, device" introduced into commerce after May 28, 1976, including "a device formerly marketed that has been substantially altered," is automatically classified by statute as class III. Id.; see also 21 U.S.C.A. 360c(f).
Second, the regulation, like the statute, discusses a "new intended use" of an existing obstetric device: "If the FDA knows that a device being commercially distributed may be a 'new' device . . . because of any new intended use . . ., the FDA may codify the statutory classification of the obstetric device into class III for such new use." 21 C.F.R. 884.3(b) (1999).