FDA 510(k) Technical Documentation

510(k) Premarket Notification submission requirements under FDA are defined by 21 CFR 807.87 and must be submitted using the eSTAR (electronic Submission Template and Resource) interactive PDF format via the CDRH Portal.

eSTAR Template (Current Version)

Template	Version	Release Date	Retirement of Previous
nIVD eSTAR	7.0	June 1, 2026	v6.2 retires August 3, 2026
IVD eSTAR	7.0	June 1, 2026	v6.2 retires August 3, 2026
PreSTAR	3.0	June 1, 2026	For pre-submissions, IDEs, 513(g)

eSTAR v7.0 Key Updates (June 2026)

• Human Factors Content: Aligned with FDA Human Factors Guidance (effective August 1, 2026)
• QMSR Alignment: Terminology updated for Quality Management System Regulation (effective February 2, 2026) -- Design and Development File (replacing DHF), Medical Device File (replacing DMR), batch records (replacing DHR)
• Real World Evidence (RWE): Structured fields for documenting real-world data sources and analytical methods (aligned with RWE guidance effective February 16, 2026)
• Reorderable Sections: Ability to adjust order of standards and additional information responses
• PMA Facility Updates: Updated facility information for PMA supplements

Document Structure (eSTAR Format per 21 CFR 807.87)

eSTAR Section	Document	Regulatory Ref
Cover	Cover Letter & Administrative Info	21 CFR 807.87
Section 3	Indications for Use Statement	21 CFR 807.87(a)
Section 4	510(k) Summary or Statement	21 CFR 807.92 / 807.93
Section 10	Substantial Equivalence Comparison	21 CFR 807.87(f)
Section 11	Device Description	21 CFR 807.87(d)
Section 12	Standards & Conformance	21 CFR 807.87(c)
Section 13	Proposed Labeling	21 CFR 807.87(e)
Section 14	Sterilization & Shelf Life	FDA Guidance
Section 15	Biocompatibility	ISO 10993-1
Section 16	Software Documentation	IEC 62304, FDA Software Guidance
Section 17	EMC / Electrical Safety	IEC 60601 series
Section 18	Performance Testing	21 CFR 807.87(g)
Section 19	Human Factors / Usability	FDA HF Guidance (2026)
Section 20	Clinical Data	21 CFR 807.87(h)

Submission Types

Type	Description	eSTAR Required
Traditional 510(k)	Full SE comparison with predicate	Yes (since Oct 2023)
Abbreviated 510(k)	Relies on FDA guidance, special controls, or recognised standards	Yes
Special 510(k)	Device modifications by original submitter	Yes
De Novo	Novel devices without predicates (Class I/II)	Yes (since Oct 2025)

Key Differences from EU MDR

Aspect	FDA 510(k)	EU MDR
Regulatory pathway	Premarket notification (substantial equivalence)	Conformity assessment (NB involvement)
Predicate / Equivalence	Predicate device (legally marketed in US)	Equivalent device per Annex XIV
Review body	FDA (CDRH or CBER)	Notified Body
Post-market	21 CFR 803/806 (MDR reporting)	PMS Plan + PSUR (Annex III)
Clinical data	Often not required for traditional 510(k)	Required for all classes (Article 61)
QMS	QMSR (21 CFR 820, amended Feb 2026)	ISO 13485 (NB audit)
Format	eSTAR (interactive PDF)	No prescribed format (BPG recommended)
Software	FDA Software Guidance + Cybersecurity Pre/Postmarket	EN 62304 + MDCG 2019-16
AI/ML	Predetermined Change Control Plan (PCCP)	MDCG guidance (evolving)

Key Regulatory References

• 21 CFR Part 807, Subpart E: Premarket Notification Procedures
• 21 CFR Part 820 (QMSR, amended February 2, 2026)
• eSTAR Program
• FDA Guidance: "The 510(k) Program -- Evaluating Substantial Equivalence"
• FDA Guidance: "Refuse to Accept Policy for 510(k)s"
• FDA Guidance: "Format for Traditional and Abbreviated 510(k)s"
• FDA Guidance: "Content of Premarket Submissions for Device Software Functions" (2023)
• FDA Guidance: "Cybersecurity in Medical Devices" (2023)
• FDA Guidance: "Human Factors Content" (effective August 1, 2026)
• FDA Guidance: "Use of Real-World Evidence to Support Regulatory Decision-Making" (effective February 16, 2026)