What is an FDA 510(k)?

Use the FDA Product Classification database:

o Identify product code, device classification (I, II, or III), and regulation number.

o Confirm that a 510(k) is the correct path (typically for most Class II devices and some Class I).

Must be legally marketed in the U.S. (pre-1976 or cleared via 510(k)).

Must have the same intended use and technological characteristics, or if different, the differences must not raise new safety/effectiveness concerns.

Ensure the device complies with applicable standards and guidelines.

Perform bench testing, biocompatibility, electrical safety, software validation, and clinical studies if needed.

Structure (can vary by format):

Cover Letter

Table of Contents

Indications for Use Statement

510(k) Summary or Statement

Device Description (materials, components, software, etc.)

Substantial Equivalence Comparison Table

Labeling (Instructions for Use, packaging, labels)

Performance Data

o Bench testing (e.g., mechanical, electrical)

o Software documentation (Level of Concern)

o Biocompatibility

o Clinical data (if applicable)

Sterilization and Shelf Life (if sterile)

Electromagnetic compatibility (EMC) & Electrical safety

Risk Analysis (per ISO 14971)

eSTAR: Interactive PDF template. Required for many Class II submissions.

Traditional PDF is still allowed for exempt categories.

MDUFA V FY2025 fee for 510(k): ~$22,500 (small business: ~ $5,600)

Register establishment & list device.

Submit electronically via CDRH Portal or ESG.

FDA checks:

o Completeness (per RTA checklist)

o Formatting and required sections

Review team evaluates:

o Substantial equivalence to predicate

o Completeness and adequacy of testing

Substantially Equivalent (SE) → 510(k) Clearance Letter (K######)

Not Substantially Equivalent (NSE) → Consider De Novo or PMA