Streaming Course

Design Changes After Clearance: When a New 510(k) Is Required

Course Information

Course Type: Streaming Course
Course ID: LSP3756
Format: Streaming
Duration: 90 Minutes
Presenter: John E. Lincoln

Registration Options

Format: Streaming
Duration: 90 Minutes

30-Day Streaming Access: USD 290.00

About the Course

Changes to a 510(k)-cleared medical device can arise from design improvements, component substitutions, labeling revisions, manufacturing changes, software updates, risk controls, or responses to field experience. Each change requires an assessment of whether it could significantly affect the device’s safety or effectiveness, or whether it represents a major change or modification in intended use. The decision determines whether the change can proceed under the existing clearance or requires submission and clearance of a new 510(k).

This course focuses on the practical evaluation of post-clearance device changes using FDA’s risk-based approach to 510(k) change assessment. It addresses how intended use, labeling, technology, performance, materials, manufacturing, and software-related changes influence the submission decision; how multiple related changes should be considered together; and how risk analysis and supporting testing inform the conclusion. Particular attention is given to documenting decisions when a new 510(k) is determined not to be required.

Key Areas Covered

FDA decision principles for determining when a device modification requires a new 510(k)
Evaluating changes to intended use, indications, labeling, and conditions of use
Assessing technology, engineering, materials, performance, and manufacturing modifications
Determining the regulatory impact of software and firmware changes
Applying risk-based assessment to changes that may affect device safety or effectiveness
Evaluating multiple related or cumulative modifications rather than treating each change in isolation
Using testing, risk analysis, and design-control evidence to support the submission decision
Documenting the rationale when a new 510(k) is determined not to be required

Who Should Attend

Regulatory Affairs Departments
Quality Assurance Departments
Design Engineering
Product Development / R&D Departments
Design Quality / Quality Engineering
Regulatory Compliance Departments
Risk Management
Software / Firmware Engineering
Manufacturing Engineering
Medical Device Quality Systems

Presenter

John E. Lincoln

John E. Lincoln brings over four decades of FDA-regulated industry experience spanning regulatory affairs, quality assurance, new and changed product 510(k)s, design controls, Design History Files, and ISO 14971 risk management. His consulting work with device modifications, submissions, validation, and FDA-facing compliance directly supports the regulatory and technical assessments addressed in this session.