21 USC 1603 - General requirements; applicability; preemption

U.S Code last checked for updates: Nov 22, 2024

§ 1603.

General requirements; applicability; preemption

(a)

General requirements

(1)

In general

In any civil action covered by this chapter, a biomaterials supplier may—

(A)

raise any exclusion from liability set forth in section 1604 of this title; and

(B)

make a motion for dismissal or for summary judgment as set forth in section 1605 of this title.

(2)

Procedures

(b)

Applicability

(1)

In general

(2)

Exclusion

A civil action brought by a purchaser of a medical device, purchased for use in providing professional health care services, for loss or damage to an implant or for commercial loss to the purchaser—

(A)

shall not be considered an action that is subject to this chapter; and

(B)

shall be governed by applicable commercial or contract law.

(c)

Scope of preemption

(1)

In general

(2)

Applicability of other laws

(d)

Statutory construction

Nothing in this chapter may be construed—

(1)

to affect any defense available to a defendant under any other provisions of Federal or State law in an action alleging harm caused by an implant; or

(2)

to create a cause of action or Federal court jurisdiction pursuant to section 1331 or 1337 of title 28 that otherwise would not exist under applicable Federal or State law.

(Pub. L. 105–230, § 4, Aug. 13, 1998, 112 Stat. 1523.)

cite as: 21 USC 1603