Scope & Applicability
Product Classes
3Defined in section 201(h) of the FD&C Act; Instrument or apparatus which does not achieve primary purpose through chemical action; Product classification based on primary intended purpose and chemical action
Defined in section 201(g) of the FD&C Act; Articles intended for use in diagnosis, cure, mitigation, treatment, or prevention of disease; Product classification based on chemical action or specific intended uses like altering pH
Subject to sampling requirements under 702(b).; Cosmetic means articles intended to be rubbed, poured, sprinkled, or sprayed on the human body
Stakeholders
2Final decision maker for FDA referrals
Individual authorized to determine and document eligibility; Individual who may be consulted regarding plasma dilution situations.
Identified Hazards
Hazards
2Serious adverse health consequences or death
Threshold for requiring an onsite audit of a supplier
Related CFR Sections (3)
- 21CFR7.55§ 7.55 Termination of a recall.
(a) A recall will be terminated when the Food and Drug Administration determines that all reasonable efforts have been made to remove or correct the product in accordance with the recall strategy, and when it is reasonable to assume that the product subject to the recall has been removed and proper Read full regulation →
- 21CFR701.9§ 701.9 Exemptions from labeling requirements.
(a) Except as provided by paragraphs (b) and (c) of this section, a shipment or other delivery of a cosmetic which is, in accordance with the practice of the trade, to be processed, labeled, or repacked in substantial quantity at an establishment other than that where originally processed or packed,Read full regulation →
- 21CFR10.115§ 10.115 Good guidance practices.
(a) What are good guidance practices? Good guidance practices (GGP's) are FDA's policies and procedures for developing, issuing, and using guidance documents.Read full regulation →
See Also (8)
- Questions and Answers Regarding Mandatory Cosmetics Recalls: Guidance for Industry : Draft Guidance for Industry (Status: Draft)
- Guidance for Industry and FDA Staff: Questions and Answers Regarding Mandatory Food Recalls (Status: Final)
- Product Recalls, Including Removals and Corrections: Guidance for Industry (Status: Final)
- CHAPTER 48 - 7348.809 Bioresearch Monitoring (Status: Final)
- The Use of Clinical Holds Following Clinical Investigator Misconduct: Guidance for Industry and Clinical Investigators (Status: Final)
- FDA Inspections of Clinical Investigators: Guidance For IRBs, Clinical Investigators, and Sponsors (Status: Final)
- Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Investigational IVDs Used in Clinical Investigations of Therapeutic Products: Draft Guidance for Industry, Food and Drug Administration Staff, Sponsors, and Institutional Review Boards (Status: Draft)