#### § 4.101 How does the FDA define key terms and phrases in this subpart?

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

*Agency or we* means Food and Drug Administration.

*Applicant* means, for the purposes of this subpart, a person holding an application under which a combination product or constituent part of a combination product has received marketing authorization (such as approval, licensure, or clearance). For the purposes of this subpart, applicant is used interchangeably with the term “you.”

*Application* means, for purposes of this subpart, a BLA, an NDA, an ANDA, or a device application, including all amendments and supplements to them.

*Biological product* has the meaning given the term in section 351 of the Public Health Service Act (42 U.S.C. 262).

*Biological product deviation report (BPDR)* is a report as described in §§ 600.14 and 606.171 of this chapter.

*Biologics license application (BLA)* has the meaning given the term in section 351 of the Public Health Service Act (42 U.S.C. 262) and § 601.2 of this chapter.

*Combination product* has the meaning given the term in § 3.2(e) of this chapter.

*Combination product applicant* means an applicant that holds the application(s) for a combination product.

*Constituent part* has the meaning given the term in § 4.2.

*Constituent part applicant* means the applicant for a constituent part of a combination product the constituent parts of which are marketed under applications held by different applicants.

*Correction or removal report* is a report as described in § 806.10 of this chapter.

*De novo classification request* is a submission requesting *de novo* classification under section 513(f)(2) of the Federal Food, Drug, and Cosmetic Act.

*Device* has the meaning given the term in section 201(h) of the Federal Food, Drug, and Cosmetic Act.

*Device application* means a PMA, PDP, premarket notification submission, *de novo* classification request, or HDE.

*Drug* has the meaning given the term in section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act.

*Field alert report* is a report as described in § 314.81 of this chapter.

*Fifteen-day report* is a report required to be submitted within 15 days as described in § 314.80 of this chapter or § 600.80 of this chapter, as well as followup reports to such a report*.*

*Five-day report* is a report as described in §§ 803.3 and 803.53 of this chapter, as well as supplemental or followup reports to such a report as described in § 803.56 of this chapter.

*Humanitarian device exemption (HDE)* has the meaning given the term in § 814.3 of this chapter.

*Malfunction report* is a report as described in § 803.50 of this chapter as well as supplemental or followup reports to such a report as described in § 803.56 of this chapter.

*New drug application (NDA)* has the meaning given the term “application” in § 314.3(b) of this chapter.

*Premarket approval application (PMA)* has the meaning given the term in § 814.3 of this chapter.

*Premarket notification submission* is a submission as described in § 807.87 of this chapter.

*Product Development Protocol (PDP)* is a submission as set forth in section 515(f) of the Federal Food, Drug, and Cosmetic Act.