§3.2. Definitions. — Inbound Citations

(p) Sponsor means “applicant” (see § 3.2(c)).

The terms listed in this section have the following meanings for purposes of this subpart:

Abbreviated new drug application (ANDA) has the same meaning given the term “abbreviated application” in § 314.3(b) of this chapter.

The terms listed in this section have the following meanings for purposes of this subpart:

The definitions of terms in section 804 of the Federal Food, Drug, and Cosmetic Act apply to the terms used in this part, if not otherwise defined in this section. The following definitions apply to this part:

(v) Whether the product is a combination product as defined in § 3.2(e) of this chapter;

(vi) Whether the product is a combination product as defined in § 3.2(e) of this chapter;

(v) Whether the product is a combination product as defined in § 3.2(e) of this chapter;

(v) Whether the product is a combination product as defined in § 3.2(e) of this chapter;

As used in this part:

(4) The product described in the De Novo request does not meet the definition of a device under section 201(h) of the Federal Food, Drug, and Cosmetic Act and is not a combination product as defined at § 3.2(e) of this chapter;

The terms listed in this section have the following meanings for purposes of this subpart:

(2) A device constituent of such a combination product whose components are physically, chemically, or otherwise combined or mixed and produced as a single entity as described by § 3.2(e)(1) of this chapter is not subject to the requirements of § 801.20.

The terms listed in this section have the following meanings for purposes of this subpart:

The terms listed in this section have the following meanings for purposes of this subpart:

The terms listed in this section have the following meanings for purposes of this subpart: