The Congress finds that-
21 U.S.C. § 1601
EDITORIAL NOTES
REFERENCES IN TEXTThe Federal Food, Drug, and Cosmetic Act, referred to in par. (6), is act June 25, 1938, ch. 675, 52 Stat. 1040, which is classified generally to chapter 9 (§301 et seq.) of this title. For complete classification of this Act to the Code, see section 301 of this title and Tables.
STATUTORY NOTES AND RELATED SUBSIDIARIES
EFFECTIVE DATE Pub. L. 105-230, §8, Aug. 13, 1998, 112 Stat. 1529, provided that: "This Act [enacting this chapter] shall apply to all civil actions covered under this Act that are commenced on or after the date of enactment of this Act [Aug. 13, 1998], including any such action with respect to which the harm asserted in the action or the conduct that caused the harm occurred before the date of enactment of this Act."
SHORT TITLE Pub. L. 105-230, §1, Aug. 13, 1998, 112 Stat. 1519, provided that: "This Act [enacting this chapter] may be cited as the 'Biomaterials Access Assurance Act of 1998'."
- medical device
- The term "medical device" means a device, as defined in section 321(h) of this title, and includes any device component of any combination product as that term is used in section 353(g) of this title.
- raw material
- The term "raw material" means a substance or product that-(A) has a generic use; and(B) may be used in an application other than an implant.