Jump to navigation
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.
§ 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
§ 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§ 360qq - Repealed.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
§ 216 - Regulations
§ 262 - Regulation of biological products
§ 263a - Certification of laboratories
§ 264 - Regulations to control communicable diseases
§ 271 - Penalties for violation of quarantine laws
Title 21 published on 20-Jun-2018 03:37
The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 4 after this date.
The Food and Drug Administration (FDA or we) is announcing the availability of an immediately in effect guidance for industry entitled “Compliance Policy for Combination Product Postmarketing Safety Reporting.” This guidance describes FDA's compliance policy for combination product applicants and constituent part applicants and activities under FDA regulations that addresses combination product postmarketing safety reporting. This guidance is immediately in effect, but it remains subject to comment in accordance with the Agency's good guidance practices.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry and FDA staff entitled “Postmarketing Safety Reporting for Combination Products.” This draft guidance addresses certain means by which applicants may comply with the final rule on postmarketing safety reporting (PMSR) requirements for combination products that FDA issued on December 20, 2016. Combination products are products composed of two or more different types of medical products (drug, device, and/or biological product). Although the PMSR regulations for drugs, devices, and biological products share many similarities, each set of regulations establishes distinct postmarketing reporting requirements, standards, and timeframes. The final rule provides clarity on the PMSR requirements for combination products to ensure consistent and complete reporting while avoiding duplication. This draft guidance is not final nor is it in effect at this time.
The Food and Drug Administration (FDA or Agency) is issuing regulations to set forth postmarketing safety reporting requirements for combination products. Specifically, this final rule describes the postmarketing safety reporting requirements that apply when two or more different types of regulated medical products (drugs, devices, and/or biological products, which are referred to as “constituent parts” of a combination product) comprise a combination product and the combination product or its constituent parts have received FDA marketing authorization. The rule is intended to promote and protect the public health by setting forth the requirements for postmarketing safety reporting for these combination products, and is part of FDA's ongoing effort to ensure the consistency and appropriateness of the regulatory requirements for combination products.
The Food and Drug Administration (FDA or Agency) is issuing this regulation on the current good manufacturing practice (CGMP) requirements applicable to combination products. This rule is intended to promote the public health by clarifying which CGMP requirements apply when drugs, devices, and biological products are combined to create combination products. In addition, the rule sets forth a transparent and streamlined regulatory framework for firms to use when demonstrating compliance with CGMP requirements for “single-entity” and “co-packaged” combination products.