{"data":{"id":"us/21-cfr-4.101","jurisdiction":"us","citation":"21 CFR 4.101","heading":"How does the FDA define key terms and phrases in this subpart?","body":"Abbreviated new drug application (ANDA) has the same meaning given the term “abbreviated application” in § 314.3(b) of this chapter.\nAgency or we means Food and Drug Administration.\nApplicant 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.”\nApplication means, for purposes of this subpart, a BLA, an NDA, an ANDA, or a device application, including all amendments and supplements to them.\nBiological product has the meaning given the term in section 351 of the Public Health Service Act (42 U.S.C. 262).\nBiological product deviation report (BPDR) is a report as described in §§ 600.14 and 606.171 of this chapter.\nBiologics 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.\nCombination product has the meaning given the term in § 3.2(e) of this chapter.\nCombination product applicant means an applicant that holds the application(s) for a combination product.\nConstituent part has the meaning given the term in § 4.2.\nConstituent 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.\nCorrection or removal report is a report as described in § 806.10 of this chapter.\nDe novo classification request is a submission requesting de novo classification under section 513(f)(2) of the Federal Food, Drug, and Cosmetic Act.\nDevice has the meaning given the term in section 201(h) of the Federal Food, Drug, and Cosmetic Act.\nDevice application means a PMA, PDP, premarket notification submission, de novo classification request, or HDE.\nDrug has the meaning given the term in section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act.\nField alert report is a report as described in § 314.81 of this chapter.\nFifteen-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.\nFive-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.\nHumanitarian device exemption (HDE) has the meaning given the term in § 814.3 of this chapter.\nMalfunction 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.\nNew drug application (NDA) has the meaning given the term “application” in § 314.3(b) of this chapter.\nPremarket approval application (PMA) has the meaning given the term in § 814.3 of this chapter.\nPremarket notification submission is a submission as described in § 807.87 of this chapter.\nProduct Development Protocol (PDP) is a submission as set forth in section 515(f) of the Federal Food, Drug, and Cosmetic Act.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER A—GENERAL","PART 4—REGULATION OF COMBINATION PRODUCTS","Subpart B—Postmarketing Safety Reporting for Combination Products"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"e91b7192d657f7bc680562dd153bde339c90b14a501d6bc31466dd5bff0d4e84","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-4.100","next":"us/21-cfr-4.102"},"notice":"GroundRules: Original legal text. Not legal advice."}