21 USC 1602 - Definitions

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

§ 1602.

Definitions

As used in this chapter:

(1)

Biomaterials supplier

(A)

In general

(B)

Persons included

Such term includes any person who—

(i)

has submitted master files to the Secretary for purposes of premarket approval of a medical device; or

(ii)

licenses a biomaterials supplier to produce component parts or raw materials.

(2)

Claimant

(A)

In general

(B)

Action brought on behalf of an estate

(C)

Action brought on behalf of a minor or incompetent

(D)

Exclusions

Such term does not include—

(i)

a provider of professional health care services in any case in which—

(I)

the sale or use of an implant is incidental to such services; and

(II)

the essence of the professional health care services provided is the furnishing of judgment, skill, or services;

(ii)

a person acting in the capacity of a manufacturer, seller, or biomaterials supplier; or

(iii)

a person alleging harm caused by either the silicone gel or the silicone envelope utilized in a breast implant containing silicone gel, except that—

(I)

neither the exclusion provided by this clause nor any other provision of this chapter may be construed as a finding that silicone gel (or any other form of silicone) may or may not cause harm; and

(II)

the existence of the exclusion under this clause may not—

(aa)

be disclosed to a jury in any civil action or other proceeding; and

(bb)

except as necessary to establish the applicability of this chapter, otherwise be presented in any civil action or other proceeding.

(3)

Component part

(A)

In general

(B)

Certain components

Such term includes a manufactured piece of an implant that—

(i)

has significant non-implant applications; and

(ii)

alone, has no implant value or purpose, but when combined with other component parts and materials, constitutes an implant.

(4)

Harm

(A)

In general

The term “harm” means—

(i)

any injury to or damage suffered by an individual;

(ii)

any illness, disease, or death of that individual resulting from that injury or damage; and

(iii)

any loss to that individual or any other individual resulting from that injury or damage.

(B)

Exclusion

(5)

Implant

The term “implant” means—

(A)

a medical device that is intended by the manufacturer of the device—

(i)

to be placed into a surgically or naturally formed or existing cavity of the body for a period of at least 30 days; or

(ii)

to remain in contact with bodily fluids or internal human tissue through a surgically produced opening for a period of less than 30 days; and

(B)

suture materials used in implant procedures.

(6)

Manufacturer

The term “manufacturer” means any person who, with respect to an implant—

(A)

is engaged in the manufacture, preparation, propagation, compounding, or processing (as defined in section 360(a)(1) of this title) of the implant; and

(B)

is required—

(i)

to register with the Secretary pursuant to section 360 of this title and the regulations issued under such section; and

(ii)

to include the implant on a list of devices filed with the Secretary pursuant to section 360(j) of this title and the regulations issued under such section.

(7)

Medical device

(8)

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.

(9)

Secretary

(10)

Seller

(A)

In general

(B)

Exclusions

The term does not include—

(i)

a seller or lessor of real property;

(ii)

a provider of professional health care services in any case in which—

(I)

the sale or use of the implant is incidental to such services; and

(II)

the essence of the professional health care services provided is the furnishing of judgment, skill, or services; or

(iii)

any person who acts in only a financial capacity with respect to the sale of an implant.

(Pub. L. 105–230, § 3, Aug. 13, 1998, 112 Stat. 1520.)

cite as: 21 USC 1602