FDA Forms & Templates
The official FDA submission and reporting forms and templates, sourced from FDA and linked to the source.
⭐Featured Templates
FDA CAR-T Cell Therapy Development Guidance
Food and Drug Administration
FDA guidance on considerations for the development of Chimeric Antigen Receptor (CAR) T cell products including CMC, preclinical, and clinical requirements
FDA Good Machine Learning Practice (GMLP) Guiding Principles
Food and Drug Administration
Guiding principles for good machine learning practice for medical device development jointly issued by FDA, Health Canada, and MHRA
FDA AI/ML Software as Medical Device (SaMD) Action Plan
Food and Drug Administration
FDA action plan for artificial intelligence and machine learning-based software as medical device outlining regulatory framework and future actions
FDA Predetermined Change Control Plan (PCCP) for AI-Enabled Devices
Food and Drug Administration
Final guidance on marketing submission recommendations for predetermined change control plans for AI-enabled device software functions
BLA — Providing Regulatory Submissions to CBER (Guidance)
FDA
FDA Guidance: "Providing Regulatory Submissions in Electronic Format — Submissions Under Section 745A(a) of the Federal Food, Drug, and Cosmetic Act" (CBER focus). Covers electronic submission methods including eCTD format used for BLAs (Biologics License Applications). (Note: FDA does not publish a single fillable BLA application form; submissions follow eCTD format.)
IND Application — Content and Format Guidance for Industry
FDA
FDA Guidance for Industry: "Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs". The authoritative FDA reference document describing what an IND submission must contain and how it must be formatted. (Note: the fillable IND cover sheet Form FDA 1571 is a dynamic XFA PDF that requires Adobe Acrobat Reader and does not render in browsers; this Guidance document is the most directly relevant English reference that renders inline.)
510(k) Premarket Notification — Guidance for Industry
FDA
FDA Guidance for Industry and FDA Staff: "The 510(k) Program — Evaluating Substantial Equivalence in Premarket Notifications". The authoritative FDA reference document describing what a 510(k) submission must contain and how substantial equivalence is evaluated. (Note: the fillable 510(k) cover sheet Form FDA 3514 is a dynamic XFA PDF that requires Adobe Acrobat Reader and does not render in browsers; this Guidance document is the most directly relevant English reference that renders inline.)
PMA Acceptance Review (RTA) Guidance for Industry
FDA
FDA Guidance: "PMA Acceptance Review (Refuse-to-Accept)". The official FDA reference describing the acceptance review criteria the agency applies to all PMA (Premarket Approval) submissions for Class III medical devices. (Note: this Guidance describes what must be present in a PMA submission; FDA does not publish a single fillable PMA application form template — submissions follow CTD-like dossier structure.)
📚All Templates (72)
FDA Digital Health Center of Excellence Overview
Comprehensive overview of FDA Digital Health Center of Excellence including policy guidance for software as medical device and mobile medical applications
NAFDAC Imported Drug Registration Guidelines
Guidelines for registration of imported drug products in Nigeria including human and veterinary drugs
NAFDAC Summary of Product Characteristics (SmPC) Guidelines
Guidelines for preparation of Summary of Product Characteristics for drug products in Nigeria
NAFDAC Drug Product Registration Guidelines (CTD Format)
Guidelines for preparation of product dossiers in Common Technical Document format for drug registration in Nigeria
QMSR Documentation Template
Quality Management System Regulation documentation template aligned with ISO 13485:2016. Replaces 21 CFR Part 820 QSR requirements.
SFDA Clinical Trial Application
Application for authorization to conduct clinical trials in Saudi Arabia.
Post-Market Surveillance Plan Template
Comprehensive Post-Market Surveillance plan template compliant with EU MDR Article 84 and FDA requirements.
SFDA Medical Device Change Notification
Notification form for changes to registered medical devices in Saudi Arabia.
Philippines FDA Medical Device Registration
Application form for Certificate of Product Registration for medical devices in the Philippines.
Thai FDA Medical Device Registration
Application form for registration of medical devices in Thailand based on ASEAN harmonized requirements.
Device Master Record (DMR) Template
Device Master Record template containing complete device specifications, manufacturing procedures, and quality specifications.
TFDA Adverse Event Reporting Form
Form for reporting adverse drug reactions and medical device incidents to Taiwan FDA.
SFDA Drug Registration Application
Application form for registration of pharmaceutical products in Saudi Arabia.
TFDA Medical Device Registration
Application form for pre-market approval of medical devices in Taiwan with Chinese labeling requirements.
Thai FDA Drug Registration Application
Application form for registration of pharmaceutical products with Thailand Food and Drug Administration.
Philippines FDA Drug Registration
Application form for Certificate of Product Registration (CPR) for pharmaceutical products in the Philippines.
TFDA Drug Registration Application
Application form for registration of pharmaceutical products in Taiwan following CTD format requirements.
SFDA Medical Device Marketing Authorization
Application for marketing authorization of medical devices in Saudi Arabia through SFDA MDMA system.
TFDA Clinical Trial Application
Application form for conducting clinical trials in Taiwan including IND-type studies and post-marketing studies.
FDA Integrating RCTs into Routine Clinical Practice
Guidance on integrating randomized controlled trials for drug and biological products into routine clinical practice settings.
FDA Real-World Data: Assessing Registries
Guidance on assessing registries to support regulatory decision-making for drugs and biological products.
FDA Use of RWE for Medical Devices
Guidance on using real-world evidence to support regulatory decision-making for medical devices.
FDA Expedited Programs for Serious Conditions
Guidance on expedited programs (Fast Track, Breakthrough Therapy, Accelerated Approval, Priority Review) for drugs and biologics treating serious conditions.
FDA Use of Electronic Health Records in Clinical Investigations
Guidance on using electronic health record data to support clinical investigations for drugs and biological products.
FDA Real-World Data: Assessing Electronic Health Records
Guidance on assessing electronic health records and medical claims data to support regulatory decision-making.
FDA Forms & Templates: Official FDA submission and reporting forms, sourced directly from FDA and linked to the source document.