FDA Forms & Templates
FDA forms and templates, sourced from FDA and linked to the source.
📝Forms & Templates (14)
Fillable FDA forms and document templates you can download and complete.
eSTAR: FDA's Electronic Submission Template (required for De Novo requests)
FDA requires eSTAR for De Novo and 510(k) submissions to CDRH and CBER unless exempted. FDA's eSTAR page links the current template versions (non-IVD and IVD).
Form FDA 3938: Drug Master File
FDA's Drug Master File form (Form FDA 3938), listed on FDA's forms page for the Center for Drug Evaluation and Research.
Read-only preview of an interactive form. Download the original to fill it in with Adobe Acrobat.
Form FDA 2252: Transmittal of Annual Reports for Drugs and Biologics for Human Use
The FDA cover form submitted with each annual report for an NDA or ANDA (21 CFR 314.81) or a BLA (21 CFR 601.70), as printed on the form. It is the transmittal form, not a template for the annual report itself.
Read-only preview of an interactive form. Download the original to fill it in with Adobe Acrobat.
QMSR Documentation Template
Quality Management System Regulation documentation template aligned with ISO 13485:2016. Replaces 21 CFR Part 820 QSR requirements.
Pre-Submission (Q-Sub) Request
FDA Pre-Submission template for requesting feedback on planned medical device submissions. Essential for regulatory strategy discussions.
eSTAR Submission Template
Electronic Submission Template and Resource for 510(k) and De Novo submissions. Standardized electronic format for medical device premarket submissions.
Read-only preview of an interactive form. Download the original to fill it in with Adobe Acrobat.
IDE Application Template
Investigational Device Exemption application for clinical studies of significant risk medical devices. Required before conducting pivotal clinical trials.
FDA Form 3500A - MedWatch Mandatory Reporting
Mandatory adverse event and product problem reporting form for manufacturers, importers, and device user facilities.
FDA Form 356h - Application to Market New Drug
Official FDA application form to market a new drug for human use, biological product, or antibiotic drug. Required for all NDA, BLA, and ANDA submissions.
FDA Form 3881 - Indications for Use Statement
Required form for 510(k) and De Novo submissions documenting the intended use and indications for a medical device.
Read-only preview of an interactive form. Download the original to fill it in with Adobe Acrobat.
FDA Form 1571 - IND Application
Investigational New Drug Application cover sheet. Required for all initial IND submissions and subsequent amendments.
Read-only preview of an interactive form. Download the original to fill it in with Adobe Acrobat.
FDA Form 1572 - Statement of Investigator
Statement of Investigator form required for clinical investigators participating in IND studies. Documents investigator qualifications and commitments.
REMS Document Template (Appendix A of the REMS Document Technical Conformance Guide)
FDA's REMS Document Template is Appendix A (page 9) of the REMS Document Technical Conformance Guide, which is incorporated by reference into the guidance Format and Content of a REMS Document.
FDA Form 3674 - Certification for Applications
Certifications to accompany drug, biological product, and device applications/submissions regarding clinical trial registration and results.
Read-only preview of an interactive form. Download the original to fill it in with Adobe Acrobat.
📖FDA Guidance & Frameworks (29)
FDA guidance documents and frameworks (not fillable forms). For the full library, see FDA Guidance.
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
FDA Questions and Answers on Biosimilar Development and BPCI Act
Comprehensive Q&A guidance on biosimilar development, the BPCI Act approval pathway, and demonstrating biosimilarity and interchangeability.
FDA Cybersecurity Guidance for Medical Devices
FDA cybersecurity guidance for medical device manufacturers including premarket and postmarket recommendations
FDA Use of RWE for Medical Devices
Guidance on using real-world evidence to support regulatory decision-making for medical devices.
FDA Predetermined Change Control Plan (PCCP) for AI-Enabled Devices
Final guidance on marketing submission recommendations for predetermined change control plans for AI-enabled device software functions
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 Electronic Health Records
Guidance on assessing electronic health records and medical claims data to support regulatory decision-making.
PMA Acceptance Review (RTA) Guidance for Industry
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.)
FDA Application User Fees for Combination Products
Final guidance explaining how user fees are applied to combination products reviewed in single or separate applications, consistent with PDUFA and MDUFA programs.
FDA Essential Drug Delivery Outputs for Combination Products
Draft guidance consolidating information for devices and combination products that deliver drugs and biological products, identifying essential drug delivery outputs (EDDO) for drug delivery performance.
BLA, Providing Regulatory Submissions to CBER (Guidance)
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.)
Changes to an Approved NDA or ANDA (Guidance)
Changes Being Effected supplement templates for post-approval manufacturing and labeling changes that do not require prior FDA approval.
FDA CAR-T Cell Therapy Development Guidance
FDA guidance on considerations for the development of Chimeric Antigen Receptor (CAR) T cell products including CMC, preclinical, and clinical requirements
FDA Real-World Data: Assessing Registries
Guidance on assessing registries to support regulatory decision-making for drugs and biological products.
FDA Data Standards for RWD Submissions
Guidance on data standards for drug and biological product submissions containing real-world data.
FDA Labeling for Biosimilar and Interchangeable Products
Guidance on labeling recommendations for biosimilar and interchangeable biosimilar products, including biosimilarity statements.
FDA Considerations for RWD/RWE Regulatory Decision-Making
Guidance on considerations for using real-world data and real-world evidence to support regulatory decision-making for drugs and biologics.
FDA Externally Controlled Trials Guidance
Guidance on design and conduct considerations for externally controlled trials using real-world data as external controls.
FDA Device Software Functions and Mobile Medical Applications Guidance
FDA guidance on policy for device software functions and mobile medical applications including regulatory considerations
FDA Good Machine Learning Practice (GMLP) Guiding Principles
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
FDA action plan for artificial intelligence and machine learning-based software as medical device outlining regulatory framework and future actions
FDA Human Gene Therapy CMC IND Guidance
FDA guidance on Chemistry, Manufacturing, and Control (CMC) information requirements for human gene therapy Investigational New Drug Applications (INDs)
IND Application, Content and Format Guidance for Industry
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.)
FDA Postmarketing Safety Reporting for Combination Products
Guidance on postmarketing safety reporting requirements for combination products, addressing reporting obligations for constituent parts.
FDA Framework for Real-World Evidence Program
Framework document describing FDA approach to evaluating RWD/RWE for regulatory decisions under the 21st Century Cures Act.
FDA Forms & Templates: Official FDA forms and document templates, plus related FDA guidance, sourced directly from FDA and linked to the source document.