1. CFR Part 11: Electronic Records; Electronic Signatures.
   Provides the criteria for the acceptance of electronic records and electronic signatures by the FDA, applicable to devices, biologics, and drugs.

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2. 21 CFR Part 201: Labeling Requirements for Prescription Drugs.
   Outlines the labeling requirements for prescription drugs, including the information that must be included on the label and package insert.

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3. 21 CFR Part 203: Prescription Drug Marketing Act (PDMA).
   Establishes regulations for the wholesale distribution of prescription drugs, including the requirements for drug sample distribution and record-keeping.

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4. 21 CFR Part 206: Imprinting of Solid Oral Dosage Form Drug Products for Human Use.
   Requires solid oral dosage form drug products (tablets and capsules) to be imprinted with identification codes to distinguish them.

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5. 21 CFR Part 210: Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs.
   Establishes the minimum cGMP requirements for the methods, facilities, and controls used in manufacturing, processing, packing, or holding drugs.

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6. 21 CFR Part 211: Current Good Manufacturing Practice for Finished Pharmaceuticals.
   Specifies the cGMP requirements for finished pharmaceuticals, including quality control, labeling, packaging, and storage.

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7. 21 CFR Part 314: Applications for FDA Approval to Market a New Drug.
   Details the requirements for submitting a New Drug Application (NDA) and Abbreviated New Drug Application (ANDA) to obtain FDA approval to market a new drug.

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8. 21 CFR Part 312: Investigational New Drug Application (IND).
   Governs the procedures and requirements for the submission of an IND to the FDA, allowing for clinical trials of investigational drugs.

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9. 21 CFR Part 316: Orphan Drugs.
   Provides the procedures and incentives for the development of drugs intended to treat rare diseases or conditions.

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10. 21 CFR Part 600: General Biological Products Standards.
    Establishes general standards for biologics, including testing, licensing, and reporting requirements.

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11. 21 CFR Part 601: Licensing.
    Details the requirements for the submission and approval of Biologics License Applications (BLA) to market biologic products.

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12. 21 CFR Part 610: General Biological Products Standards.
    Specifies additional standards for biologics, including potency, sterility, purity, and identity testing.

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13. 21 CFR Part 630: Requirements for Blood and Blood Components.
    Intended for Transfusion or for Further Manufacturing Use Governs the standards for blood and blood components, including donor suitability, collection, processing, and labeling.

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14. 21 CFR Part 640: Additional Standards for Human Blood and Blood Products.
    Provides additional standards specific to human blood and blood products, focusing on collection, testing, and preparation.

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15. 21 CFR Part 807: Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices.
    Outlines the requirements for registering medical device establishments and listing their devices with the FDA.

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16. 21 CFR Part 808: Exemptions from Preemption of State and Local Medical Device Requirements.
    Provides the criteria for state and local laws that are not preempted by federal regulations concerning medical devices.

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17. 21 CFR Part 809: In Vitro Diagnostic Products.
    Covers labeling, performance, and packaging requirements for in vitro diagnostic (IVD) products.

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18. 21 CFR Part 810: Medical Device Recall Authority.
    Describes the procedures and authority for recalling medical devices that are found to be defective or pose a health risk.

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19. 21 CFR Part 812: Investigational Device Exemptions (IDE).
    Governs the clinical investigation of devices to determine safety and effectiveness before FDA approval.

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20. 21 CFR Part 814: Premarket Approval of Medical Devices.
    Details the process and requirements for obtaining FDA approval to market a Class III medical device through a Premarket Approval (PMA) application.

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21. 21 CFR Part 820: Quality System Regulation (QSR) for Medical Devices.
    Establishes the cGMP requirements for medical device manufacturers, focusing on quality management systems.

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22. 21 CFR Part 821: Medical Device Tracking Requirements.
    Requires certain manufacturers to track devices to ensure they can be located quickly if safety concerns arise.

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23. 21 CFR Part 822: Postmarket Surveillance.
    Details the requirements for postmarket surveillance studies to monitor device safety and effectiveness after approval.

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24. 21 CFR Part 830: Unique Device Identification (UDI) System.
    Establishes the system for assigning and labeling unique device identifiers to medical devices.

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25. 21 CFR Part 860: Medical Device Classification Procedures
    Provides the procedures and criteria for classifying medical devices into Class I, II, or III.

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26. 21 CFR Parts 1000-1050: General Provisions for Electronic Products (e.g., Radiation-Emitting Devices).
    Sets standards for electronic products that emit radiation, including medical devices like X-ray machines.

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27. 21 CFR Part 806: Medical Devices; Reports of Corrections and Removals.
    Specifies the requirements for manufacturers and importers to report certain device corrections and removals to the FDA.

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28. 21 CFR Part 803: Medical Device Reporting (MDR).
    Outlines the requirements for manufacturers, importers, and device user facilities to report adverse events and device malfunctions to the FDA.

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29. 21 CFR Part 807, Subpart E: Premarket Notification Procedures (510(k))
    Describes the requirements for submitting a premarket notification (510(k)) to the FDA for certain medical devices.

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30. 21 CFR Part 1271: Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
    Establishes the regulations for human cells, tissues, and cellular and tissue-based products, including donor eligibility, product handling, and registration requirements.

1. NDA (New Drug Application).
   Application for approval of a new pharmaceutical for sale and marketing in the U.S.

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2. ANDA (Abbreviated New Drug Application).
   Application for the approval of a generic drug.

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3. 505(b)(2) Application.
   A new drug application that allows some information required for approval to come from studies not conducted by the applicant. The 505(b)(2) application is governed by 21 CFR Part 314, specifically under the sections that address New Drug Applications (NDAs). While there isn’t a specific standalone section for 505(b)(2) applications, the relevant sections within 21 CFR Part 314 include: 21 CFR § 314.50 Content and format of an NDA, which applies to 505(b)(1) and 505(b)(2) applications and 21 CFR § 314.54 NDAs that rely on studies not conducted by the applicant (this section specifically addresses applications like 505(b)(2)).

Relevant 21 CFR Parts

1. 21 CFR Part 312 Investigational New Drug Application (IND) Process.
   Governs the submission and maintenance of IND applications for clinical trials of new drugs.

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2. 21 CFR Part 314 Applications for FDA Approval to Market a New Drug.
   Details the submission process for NDAs and ANDAs, including safety and efficacy requirements.

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3. 21 CFR Part 320 Bioavailability and Bioequivalence Requirements.
   Sets standards for bioavailability and bioequivalence studies necessary for generic drug approval

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4. 21 CFR § 314.50 Content and Format of an NDA
   Specifies detailed requirements for the structure and content of an NDA submission.

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5. 21 CFR § 314.54 NDAs for a New Use of a Drug Product Already Marketed Under an Approved NDA.
   Covers submission requirements for applications seeking approval for new indications of existing drug products.

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6. 21 CFR § 314.101 Filing an NDA and ANDA.
   Describes the filing procedures and conditions for accepting or refusing NDAs and ANDAs.

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7. 21 CFR § 314.105 Approval of an NDA and ANDA.
   Provides criteria for NDA and ANDA approvals based on safety, efficacy, and regulatory compliance.

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8. 21 CFR § 314.125 Refusal to Approve an NDA
   Lists the reasons why the FDA may refuse to approve an NDA, including concerns with safety, labeling, or manufacturing practices.

EU MDR 2017/745, MDD 93/42/EEC, 90/385/EEC, 2007/47/EC

• EU MDR 2017/745: European Union Medical Device Regulation, replacing the MDD (Medical Device Directive).

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• ANDA (Abbreviated New Drug Application).
  Application for the approval of a generic drug.

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• MDD 93/42/EEC: The Medical Device Directive, previously governing medical device regulation in the EU.

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• 90/385/EEC: The Active Implantable Medical Device Directive (AIMDD).

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• 2007/47/EC: Amendment to the MDD and AIMDD.

MDSAP, CMDR & SOR/98-282, ANVISA, 323-FZ Roszdravnadzor, ARTG & PMDA/MHLW

• MDSAP (Medical Device Single Audit Program): A program that allows a single regulatory audit to satisfy the requirements of multiple regulatory jurisdictions.MDSAP (Medical Device Single Audit Program): A program that allows a single regulatory audit to satisfy the requirements of multiple regulatory jurisdictions.

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• CMDR (Canadian Medical Devices Regulations): Canadian regulations for medical devices.

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• SOR/98-282: The specific regulation number for Canadian Medical Devices Regulations.

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• ANVISA: The Brazilian Health Regulatory Agency.

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• 323-FZ Roszdravnadzor: Russian Federal Service for Surveillance in Healthcare.

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• ARTG (Australian Register of Therapeutic Goods): The register of therapeutic goods that can be lawfully supplied in Australia.

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• 21 CFR § 314.105 Approval of an NDA and ANDA.
  Provides criteria for NDA and ANDA approvals based on safety, efficacy, and regulatory compliance.

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• PMDA/MHLW: The Pharmaceuticals and Medical Devices Agency and the Ministry of Health, Labour and Welfare in Japan.

ISO (International Organization for Standardization)

• 13485 Medical devices – Quality management systems – Requirements for regulatory purposes.

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• 9001: Quality management systems – Requirements.

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• 14971: Medical devices – Application of risk management to medical devices.

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• TR ISO 24971: Guidance on the application of ISO 14971.

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• 10993 (Parts 1-18): Biological evaluation of medical devices.

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• 15223: Symbols to be used with medical device labels, labelling, and information to be supplied.

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• 11607: Packaging for terminally sterilized medical devices.

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• 60601: Medical electrical equipment – General requirements for basic safety and essential performance.

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• 14155: Clinical investigation of medical devices for human subjects – Good clinical practice.

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• 14644: Cleanrooms and associated controlled environments.

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• 14698: Packaging materials – Characteristics of packaging materials used in direct contact with foodstuffs, pharmaceuticals, and medical devices.

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• 17025: General requirements for the competence of testing and calibration laboratories.

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• 22442: Medical devices utilizing animal tissues and their derivatives.

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• 11608: Needle-based injection systems for medical use – Requirements and test methods.

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• 11135: Sterilization of health care products – Ethylene oxide – Requirements for the development, validation, and routine control of a sterilization process.

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• 11137: Sterilization of health care products – Radiation.

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• 17664: Processing of health care products – Information to be provided by the medical device manufacturer for the processing of medical devices.

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• 21969: Sterilization of health care products – Biological indicators.

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• 11615: Packaging – Requirements for child-resistant packaging for medicinal products.

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• 11616: Packaging – Requirements for reclosable child-resistant packaging.

IEC (International Electrotechnical Commission)

• 62304: Medical device software – Software life cycle processes.

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• 80001: Application of risk management for IT networks incorporating medical devices.

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• ISO/IEC 27001: Information security management systems – Requirements.

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• 27701: Extension to ISO/IEC 27001 and ISO/IEC 27002 for privacy information management.

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• 29100: Privacy framework.

MEDDEV

• 2.1/1: Definitions of "medical device" and "accessory."

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• 2.1/6: Qualification and classification of stand-alone software used in healthcare.

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• 2.7/1: Clinical evaluation.

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• 2.12/1: Vigilance system.

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• 2.12/2: Post-market clinical follow-up.

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• 2.14/1: The status of borderlines between Directive 93/42/EEC and other Directives.

NBOG (Notified Body Operations Group)

• BPG 2009-1: Best practice guidance on notified body designation.

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• 2010-1: Guidance on unannounced audits.

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• 2010-3: Guidance on subcontracting by notified bodies.

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• F 2010-1: Application for designation as a notified body.

GHTF (Global Harmonization Task Force)

• SG1/N70: Labeling for medical devices.

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• SG1/N77: Essential principles of safety and performance.

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• SG1/N78: Principles of conformity assessment for medical devices.

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• SG1/N046: Principles of in vitro diagnostic (IVD) medical devices classification.

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• SG3/N15: Risk management principles and activities within a Quality Management System.

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• SG4/N28: Guidelines for regulatory auditing of Quality Management Systems of medical device manufacturers.

FDA Guidance for Industry

• Guidance documents issued by the FDA to assist manufacturers in meeting regulatory requirements.

ISO/IEC

• 17021: Requirements for bodies providing audit and certification of management systems.

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• 19011: Guidelines for auditing management systems.

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• 17025: Requirements for the competence of testing and calibration laboratories.

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• 17065: Requirements for bodies certifying products, processes, and services.

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• 17020: Requirements for the operation of various types of bodies performing inspection.

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• 17024: General requirements for bodies operating certification of persons.

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• 17029: Conformity assessment – General principles and requirements for validation and verification bodies.

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• 27006: Requirements for bodies providing audit and certification of information security management systems.

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• 20000-1: Information technology – Service management – Part 1: Service management system requirements.

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• 17043: Conformity assessment – General requirements for proficiency testing.

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• 45001: Occupational health and safety management systems – Requirements.

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• 50001: Energy management systems – Requirements.

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• 22301: Business continuity management systems – Requirements.