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20 results 360e-4
Scoped to Title 21
Exact match Title 21 Title 21 / Chapter 9 FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter V DRUGS AND DEVICES / Part A Drugs and Devices / Section 360e–4

21 U.S.C. § 360e–4

Predetermined change control plans for devices

Subchapter V DRUGS AND DEVICES / Part A Drugs and Devices

Exact citation match for 21 USC § 360E-4

Title 21 Title 21 / Section 360e

21 U.S.C. § 360e

Premarket approval

Subchapter V DRUGS AND DEVICES / Part A Drugs and Devices

Premarket approval

Title 21 Title 21 / Section 360

21 U.S.C. § 360

Registration of producers of drugs or devices

Subchapter V DRUGS AND DEVICES / Part A Drugs and Devices

Registration of producers of drugs or devices

Title 21 Title 21 / Section 379j

21 U.S.C. § 379j

Authority to assess and use device fees

Part C Fees / Subpart 3 fees relating to devices

Authority to assess and use device fees

Title 21 Title 21 / Section 360e–3

21 U.S.C. § 360e–3

Breakthrough devices

Subchapter V DRUGS AND DEVICES / Part A Drugs and Devices

Breakthrough devices

Title 21 Title 21 / Section 379i

21 U.S.C. § 379i

Definitions

Part C Fees / Subpart 3 fees relating to devices

Definitions

Title 21 Title 21 / Section 382

21 U.S.C. § 382

Exports of certain unapproved products

Chapter 9 FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter VIII IMPORTS AND EXPORTS

Exports of certain unapproved products

Title 21 Title 21 / Section 356–1

21 U.S.C. § 356–1

Accelerated approval of priority countermeasures

Subchapter V DRUGS AND DEVICES / Part A Drugs and Devices

Accelerated approval of priority countermeasures

Title 21 Title 21 / Section 360g

21 U.S.C. § 360g

Judicial review

Subchapter V DRUGS AND DEVICES / Part A Drugs and Devices

Judicial review

Title 21 Title 21 / Section 360n–2

21 U.S.C. § 360n–2

Ensuring cybersecurity of devices

Subchapter V DRUGS AND DEVICES / Part A Drugs and Devices

Ensuring cybersecurity of devices

Title 21 Title 21 / Section 360bbb–3b

21 U.S.C. § 360bbb–3b

Products held for emergency use

Subchapter V DRUGS AND DEVICES / Part E General Provisions Relating to Drugs and Devices

Products held for emergency use

Title 21 Title 21 / Section 360j

21 U.S.C. § 360j

General provisions respecting control of devices intended for human use

Subchapter V DRUGS AND DEVICES / Part A Drugs and Devices

General provisions respecting control of devices intended for human use

Title 21 Title 21 / Section 360bbb–3

21 U.S.C. § 360bbb–3

Authorization for medical products for use in emergencies

Subchapter V DRUGS AND DEVICES / Part E General Provisions Relating to Drugs and Devices

Authorization for medical products for use in emergencies

Title 21 Title 21 / Section 360bbb–3c

21 U.S.C. § 360bbb–3c

Expedited development and review of medical products for emergency uses

Subchapter V DRUGS AND DEVICES / Part E General Provisions Relating to Drugs and Devices

Expedited development and review of medical products for emergency uses

Title 21 Title 21 / Section 379j–1

21 U.S.C. § 379j–1

Reauthorization; reporting requirements

Part C Fees / Subpart 3 fees relating to devices

Reauthorization; reporting requirements

Title 21 Title 21 / Section 331

21 U.S.C. § 331

Prohibited acts

Chapter 9 FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter III PROHIBITED ACTS AND PENALTIES

Prohibited acts

Title 21 Title 21 / Section 399g

21 U.S.C. § 399g

Food and Drug Administration Intercenter Institutes

Chapter 9 FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter X MISCELLANEOUS

Food and Drug Administration Intercenter Institutes

Title 21 Title 21 / Section 352

21 U.S.C. § 352

Misbranded drugs and devices

Subchapter V DRUGS AND DEVICES / Part A Drugs and Devices

Misbranded drugs and devices

Title 21 Title 21 / Section 356j

21 U.S.C. § 356j

Discontinuance or interruption in the production of medical devices

Subchapter V DRUGS AND DEVICES / Part A Drugs and Devices

Discontinuance or interruption in the production of medical devices

Title 21 Title 21 / Section 360a–2

21 U.S.C. § 360a–2

Susceptibility test interpretive criteria for microorganisms

Subchapter V DRUGS AND DEVICES / Part A Drugs and Devices

Susceptibility test interpretive criteria for microorganisms