21 CFR 4.101 - How does the FDA define key terms and phrases in this subpart?

§ 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.

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].

It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.


United States Code
U.S. Code: Title 21 - FOOD AND DRUGS

§ 321 - Definitions; generally

§ 331 - Prohibited acts

§ 351 - Adulterated drugs and devices

§ 353 - Exemptions and consideration for certain drugs, devices, and biological products

§ 355 - New drugs

§ 360 - Registration of producers of drugs or devices

§ 360b - New animal drugs

§ 360c - Classification of devices intended for human use

§ 360d - Performance standards

§ 360e - Premarket approval

§ 360e-1

§ 360f - Banned devices

§ 360h - Notification and other remedies

§ 360i - Records and reports on devices

§ 360j - General provisions respecting control of devices intended for human use

§ 360l - Postmarket surveillance

§ 360hh - Definitions

§ 360ii - Program of control

§ 360jj - Studies by Secretary

§ 360kk - Performance standards for electronic products

§ 360ll - Notification of defects in and repair or replacement of electronic products

§ 360mm - Imports

§ 360nn - Inspection, records, and reports

§ 360oo - Prohibited acts

§ 360pp - Enforcement

§ 360qq - Repealed. Pub. L. 105–362, title VI, § 601(a)(2)(A), Nov. 10, 1998, 112 Stat. 3285

§ 360rr - Federal-State cooperation

§ 360ss - State standards

§ 360aaa - Omitted

§ 360bbb - Expanded access to unapproved therapies and diagnostics

§ 371 - Regulations and hearings

§ 372 - Examinations and investigations

§ 373 - Records

§ 374 - Inspection

§ 379e - Listing and certification of color additives for foods, drugs, devices, and cosmetics

§ 381 - Imports and exports

§ 383 - Office of International Relations

§ 394 - Scientific review groups

U.S. Code: Title 42 - THE PUBLIC HEALTH AND WELFARE

Title 21 published on 09-Jun-2018 03:51

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 4 after this date.

  • 2018-03-21; vol. 83 # 55 - Wednesday, March 21, 2018
    1. 83 FR 12259 - Immediately in Effect Guidance for Industry; Compliance Policy for Combination Product Postmarketing Safety Reporting; Availability
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Notification of availability.
      The announcement of the guidance is published in the Federal Register on March 21, 2018.
      21 CFR Part 4