add a new specification or test method, or otherwise provide additional assurance of purity, identity, strength, or reliability of the device. [PMA Supplements, 21 C.F.R. § 814.39(d) (1999).] 18 We observe that plaintiffs' argument that "Dear Doctor” letters, telegrams, or other similar materials are not "labeling” changes under 21 U.S.C. § 321(m) is wrong. Those alternative methods of warning the Test's users suggested by plaintiffs clearly constitute "labeling” under the FDCA. Cases interpreting the definition of “labeling” have held that “it is clear that supplementary or explanatory information disseminated by the producer of a drug or device may constitute labeling,' regardless of whether it physically accompanies the product.” Washington Lega 4, 656 N.Y.S.2d 16 (N.Y.App.Div.1997) (<HOLDING>); Goodlin v. Medtronic, 167 F.3d 1367, 1376 (11
holding that where a regulation could not fairly be read to have spoken at all on an issue an agencys proposed interpretation of the regulation as it pertained to that issue was not a reasonable interpretation of the regulation holding that the challenge to a university regulation was moot because the regulation had been substantially amended holding that pma process is not specific regulation because the requirements are not contained in formal regulation holding that pma process is not specific requirement because of lack of substantive prerequisites for approval holding that verbal requirement of need not contained in hunting regulation was addition of substance and thus regulation under apa