cfr_sections
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10 rows where part_number = 4 and title_number = 21 sorted by section_id
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| section_id ▼ | title_number | title_name | chapter | subchapter | part_number | part_name | subpart | subpart_name | section_number | section_heading | agency | authority | source_citation | amendment_citations | full_text |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 21:21:1.0.1.1.4.1.98.1 | 21 | Food and Drugs | I | A | 4 | PART 4—REGULATION OF COMBINATION PRODUCTS | A | Subpart A—Current Good Manufacturing Practice Requirements for Combination Products | § 4.1 What is the scope of this subpart? | FDA | This subpart applies to combination products. It establishes which current good manufacturing practice requirements apply to these products. This subpart clarifies the application of current good manufacturing practice regulations to combination products, and provides a regulatory framework for designing and implementing the current good manufacturing practice operating system at facilities that manufacture co-packaged or single-entity combination products. | ||||
| 21:21:1.0.1.1.4.1.98.2 | 21 | Food and Drugs | I | A | 4 | PART 4—REGULATION OF COMBINATION PRODUCTS | A | Subpart A—Current Good Manufacturing Practice Requirements for Combination Products | § 4.2 How does FDA define key terms and phrases in this subpart? | FDA | [89 FR 57165, June 2, 2024] | The terms listed in this section have the following meanings for purposes of this subpart: Biological product has the meaning set forth in § 3.2(d) of this chapter. A biological product also meets the definitions of either a drug or device as these terms are defined under this section. Combination product has the meaning set forth in § 3.2(e) of this chapter. Constituent part is a drug, device, or biological product that is part of a combination product. Co-packaged combination product has the meaning set forth in § 3.2(e)(2) of this chapter. Current good manufacturing practice operating system means the operating system within an establishment that is designed and implemented to address and meet the current good manufacturing practice requirements for a combination product. Current good manufacturing practice requirements means the requirements set forth under § 4.3(a) through (e). Device has the meaning set forth in § 3.2(f) of this chapter. A device that is a constituent part of a combination product is considered a finished device within the meaning of the Quality Management System Regulation (QMSR). Drug has the meaning set forth in § 3.2(g) of this chapter and includes medical gas as defined in section 575(2) of the Federal Food, Drug, and Cosmetic Act. Medical gas includes designated medical gases as defined in section 575(1) of the Federal Food, Drug, and Cosmetic Act and medical gases approved under section 505 of the Federal Food, Drug, and Cosmetic Act. A drug other than a medical gas that is a constituent part of a combination product is considered a drug product within the meaning of the drug current good manufacturing practice (CGMP) requirements. A drug that is a medical gas that is a constituent part of a combination product is considered a medical gas within the meaning of the medical gas CGMP requirements. Drug CGMP requirements refers to the current good manufacturing practice regulations set forth in parts 210 and 211 of this chapter. HCT/Ps refers to human cell, tissue, an… | |||
| 21:21:1.0.1.1.4.1.98.3 | 21 | Food and Drugs | I | A | 4 | PART 4—REGULATION OF COMBINATION PRODUCTS | A | Subpart A—Current Good Manufacturing Practice Requirements for Combination Products | § 4.3 What current good manufacturing practice requirements apply to my combination product? | FDA | [78 FR 4321, Jan. 22, 2013, as amended at 89 FR 51766, June 18, 2024] | If you manufacture a combination product, the requirements listed in this section apply as follows: (a) The current good manufacturing practice requirements in parts 210 and 211 of this chapter apply to a combination product that includes a drug constituent part other than a medical gas; (b) The current good manufacturing practice requirements in part 820 of this chapter apply to a combination product that includes a device constituent part; (c) The current good manufacturing practice requirements among the requirements (including standards) for biological products in parts 600 through 680 of this chapter apply to a combination product that includes a biological product constituent part to which those requirements would apply if that constituent part were not part of a combination product; (d) The current good tissue practice requirements including donor eligibility requirements for HCT/Ps in part 1271 of this chapter apply to a combination product that includes an HCT/P; and (e) The current good manufacturing practice requirements in part 213 of this chapter apply to a combination product that includes a drug constituent part that is a medical gas. | |||
| 21:21:1.0.1.1.4.1.98.4 | 21 | Food and Drugs | I | A | 4 | PART 4—REGULATION OF COMBINATION PRODUCTS | A | Subpart A—Current Good Manufacturing Practice Requirements for Combination Products | § 4.4 How can I comply with these current good manufacturing practice requirements for a co-packaged or single-entity combination product? | FDA | [78 FR 4321, Jan. 22, 2013, as amended at 89 FR 7522, Feb. 2, 2024; 89 FR 51766, June 18, 2024] | (a) Under this subpart, for single entity or co-packaged combination products, compliance with all applicable current good manufacturing practice requirements for the combination product shall be achieved through the design and implementation of a current good manufacturing practice operating system that is demonstrated to comply with: (1) The specifics of each set of current good manufacturing practice regulations listed under § 4.3 as they apply to each constituent part included in the combination product; or (2) Paragraph (b) of this section. (b) If you elect to establish a current good manufacturing practice operating system in accordance with paragraph (b) of this section, the following requirements apply: (1) If the combination product includes a device constituent part and a drug constituent part, and the current good manufacturing practice operating system has been shown to comply with the drug CGMP requirements or the medical gas CGMP requirements, as applicable, the following clauses of ISO 13485 (together with the definitions in Clause 3 of ISO 9000), which is incorporated by reference into the QMSR under § 820.7 of this chapter, and certain other provisions within the QMSR must also be shown to have been satisfied; upon demonstration that these requirements have been satisfied, no additional showing of compliance with respect to the QMSR need be made: (i) General requirements and management responsibility. Clause 4.1, Clause 5 and its subclauses, Clause 6.1 of ISO 13485, and § 820.10 of this chapter; (ii) Design and development. Clause 7.3 and its subclauses of ISO 13485. The organization shall document one or more processes for risk management in product realization. Records of risk management activities shall be maintained; (iii) Purchasing. Clause 7.4. and its subclauses of ISO 13485; (iv) Analysis of data, improvement, and complaint handling. Clause 8.2.2 and § 820.35(a) of this chapter, Clause 8.4, and Clause 8.5. and its subclauses of ISO 13485; (v) Installation activities. Cl… | |||
| 21:21:1.0.1.1.4.2.98.1 | 21 | Food and Drugs | I | A | 4 | PART 4—REGULATION OF COMBINATION PRODUCTS | B | Subpart B—Postmarketing Safety Reporting for Combination Products | § 4.100 What is the scope of this subpart? | FDA | (a) This subpart identifies postmarketing safety reporting requirements for combination product applicants and constituent part applicants. (b) This subpart does not apply to investigational combination products, combination products that have not received marketing authorization, or to persons other than combination product applicants and constituent part applicants. (c) This subpart supplements and does not supersede other provisions of this chapter, including the provisions in parts 314, 600, 606, 803, and 806 of this chapter, unless a regulation explicitly provides otherwise. | ||||
| 21:21:1.0.1.1.4.2.98.2 | 21 | Food and Drugs | I | A | 4 | PART 4—REGULATION OF COMBINATION PRODUCTS | B | Subpart B—Postmarketing Safety Reporting for Combination Products | § 4.101 How does the FDA define key terms and phrases in this subpart? | FDA | 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… | ||||
| 21:21:1.0.1.1.4.2.98.3 | 21 | Food and Drugs | I | A | 4 | PART 4—REGULATION OF COMBINATION PRODUCTS | B | Subpart B—Postmarketing Safety Reporting for Combination Products | § 4.102 What reports must you submit to FDA for your combination product or constituent part? | FDA | (a) In general. If you are a constituent part applicant, the reporting requirements applicable to you that are identified in this section apply to your constituent part, and if you are a combination product applicant, the reporting requirements applicable to you that are identified in this section apply to your combination product as a whole. (b) Reporting requirements applicable to both combination product applicants and constituent part applicants. If you are a combination product applicant or constituent part applicant, you must comply with the reporting requirements identified in paragraphs (b)(1), (b)(2), or (b)(3) of this section for your product based on its application type. If you are a combination product applicant, you are required to submit a report as specified in this paragraph unless you have already submitted a report in accordance with paragraph (c) of this section for the same event that: Includes the information required under the applicable regulations identified in this paragraph, is required to be submitted in the same manner under § 4.104, and meets the deadlines under the applicable regulations identified in this paragraph. (1) If your combination product or device constituent part received marketing authorization under a device application, you must comply with the requirements for postmarketing safety reporting described in parts 803 and 806 of this chapter with respect to your product. (2) If your combination product or drug constituent part received marketing authorization under an NDA or ANDA, you must comply with the requirements for postmarketing safety reporting described in part 314 of this chapter with respect to your product. (3) If your combination product or biological product constituent part received marketing authorization under a BLA, you must comply with the requirements for postmarketing safety reporting described in parts 600 and 606 of this chapter with respect to your product. (c) Reporting requirements applicable only to combination product applicants. If … | ||||
| 21:21:1.0.1.1.4.2.98.4 | 21 | Food and Drugs | I | A | 4 | PART 4—REGULATION OF COMBINATION PRODUCTS | B | Subpart B—Postmarketing Safety Reporting for Combination Products | § 4.103 What information must you share with other constituent part applicants for the combination product? | FDA | (a) When you receive information regarding an event that involves a death or serious injury as described in § 803.3 of this chapter, or an adverse experience as described in § 314.80(a) of this chapter or § 600.80(a) of this chapter, associated with the use of the combination product, you must provide the information to the other constituent part applicant(s) for the combination product no later than 5 calendar days of your receipt of the information. (b) With regard to information you must provide to the other constituent part applicant(s) for the combination product, you must maintain records that include: (1) A copy of the information you provided, (2) The date the information was received by you, (3) The date the information was provided to the other constituent part applicant(s), and (4) The name and address of the other constituent part applicant(s) to whom you provided the information. | ||||
| 21:21:1.0.1.1.4.2.98.5 | 21 | Food and Drugs | I | A | 4 | PART 4—REGULATION OF COMBINATION PRODUCTS | B | Subpart B—Postmarketing Safety Reporting for Combination Products | § 4.104 How and where must you submit postmarketing safety reports for your combination product or constituent part? | FDA | (a) If you are a constituent part applicant, you must submit postmarketing safety reports in accordance with the regulations identified in § 4.102(b) that are applicable to your product based on its application type. (b) If you are a combination product applicant, you must submit postmarketing safety reports required under § 4.102 in the manner specified in the regulation applicable to the type of report, with the following exceptions: (1) You must submit the postmarketing safety reports identified in § 4.102(c)(1)(i) and (ii) in accordance with § 314.80(g) of this chapter if your combination product received marketing authorization under an NDA or ANDA or in accordance with § 600.80(h) of this chapter if your combination product received marketing authorization under a BLA. (2) You must submit the postmarketing safety reports identified in § 4.102(c)(2)(ii) and (c)(3)(ii) in accordance with § 803.12(a) of this chapter if your combination product received marketing authorization under a device application. | ||||
| 21:21:1.0.1.1.4.2.98.6 | 21 | Food and Drugs | I | A | 4 | PART 4—REGULATION OF COMBINATION PRODUCTS | B | Subpart B—Postmarketing Safety Reporting for Combination Products | § 4.105 What are the postmarketing safety reporting recordkeeping requirements for your combination product or constituent part? | FDA | (a) If you are a constituent part applicant: (1) You must maintain records in accordance with the recordkeeping requirements in the applicable regulation(s) described in § 4.102(b). (2) You must maintain records required under § 4.103(b) for the longest time period required for records under the postmarketing safety reporting regulations applicable to your product under § 4.102(b). (b) If you are a combination product applicant, you must maintain records in accordance with the longest time period required for records under the regulations applicable to your product under § 4.102. |
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CREATE TABLE cfr_sections (
section_id TEXT PRIMARY KEY,
title_number INTEGER,
title_name TEXT,
chapter TEXT,
subchapter TEXT,
part_number TEXT,
part_name TEXT,
subpart TEXT,
subpart_name TEXT,
section_number TEXT,
section_heading TEXT,
agency TEXT,
authority TEXT,
source_citation TEXT,
amendment_citations TEXT,
full_text TEXT
);
CREATE INDEX idx_cfr_title ON cfr_sections(title_number);
CREATE INDEX idx_cfr_part ON cfr_sections(part_number);
CREATE INDEX idx_cfr_agency ON cfr_sections(agency);