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e-CFR data is current as of February 25, 2021

Title 21Chapter ISubchapter APart 4Subpart B → §4.101


Title 21: Food and Drugs
PART 4—REGULATION OF COMBINATION PRODUCTS
Subpart B—Postmarketing Safety Reporting for Combination Products


§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.

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