STATEMENTS OF UNDERSTANDING

Statement of Understanding -

medical equipment

Commodities that are 'specially designed for medical end-use' that 'incorporate' commodities or software on the Commerce Control List (Sup
plement No. 1 to part 774 of the EAR) that do not have a reason for control of Nuclear Nonproliferation (NP), Missile Technology (MT), or Chemical & Biological Weapons (CB) are designated by the number EAR99 (i.e., are not elsewhere specified on the Commerce Control List).

NOTES applicable to State of Understanding related to Medical Equipment:

(1) 'Specially designed for medical end-use' means designed for medical treatment or the practice of medicine (does not include medi
cal research).

•(2) Commodities or software are consid
ered 'incorporated' if the commodity or soft
ware is: Essential to the functioning of the medical equipment; customarily included in the sale of the medical equipment; and ex
ported or reexported with the medical equip
ment.

(3) Except for such software that is made publicly available consistent with §734.3(b)(3) of the EAR, commodities and software 'specially designed for medical end-
use' remain subject to the EAR.

(4) See also §770.2(b) interpretation 2, for other types of equipment that incorporate items on the Commerce Control List that are subject to the EAR.

(5) For computers used with medical equip
ment, see also ECCN 4A003 note 2 regarding the "principal element" rule.

(6) For commodities and software specially designed for medical end-use that incorpo
rate an encryption or other "information se
curity" item subject to the EAR, see also Note 1 to Category 5, Part II of the Commerce Control List.

Statement of Understanding - Source Code

For the purpose of national security controlled items, "source code" items are controlled either by "software" or by "software" and "technology" controls, except when such "source code" items are explicitly decontrolled.