21 CFR § 4.101 - How does the FDA define key terms and phrases in this subpart?
---
identifier: "/us/cfr/t21/s4.101"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 4.101 - How does the FDA define key terms and phrases in this subpart?"
title_number: 21
title_name: "Food and Drugs"
section_number: "4.101"
section_name: "How does the FDA define key terms and phrases in this subpart?"
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "A"
subchapter_name: "GENERAL"
part_number: "4"
part_name: "REGULATION OF COMBINATION PRODUCTS"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 321, 331, 351, 352, 353, 355, 360, 360b-360f, 360h-360j, 360l, 360hh-360ss, 360aaa-360bbb, 360ddd, 360ddd-1, 371(a), 372-374, 379e, 381, 383, 394; 42 U.S.C. 216, 262, 263a, 264, 271."
regulatory_source: "78 FR 4321, Jan. 22, 2013, unless otherwise noted."
cfr_part: "4"
---
# 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.