Webinar On 510(k) Updates: Trends, New Strategy and FDA Clearance

This webinar will provide an opportunity to get familiar with an FDA’s process to communicate with the industry early in the process for sustainable 510(k) preparation and submission including recent 510(k) trends and updates.

Areas Covered in the Session :

Statute(s) And Regulations

Definitions

Device Classification

Identifying Predicates: Key Factors

510(k) Program

When a 510(k) Is Required

Applicable Regulatory Requirements: Biocompatibility, Software, Risk Management, etc.

Pre-Submission (Q-Submission) for a 510(k): Requirements, Contents and Format

Substantial Equivalence: Factors to Consider and Special Considerations

Addressing e-Copy And RTA Policy Requirements

Common Mistakes for RTA Policy Requirements

Applicable Standards and Guidance

510(k) Contents And Format

Common Pitfalls and How to Prevent Them

What to Ensure While Preparing Your Q-Submission and a 510(k) Application

Responding to FDA’s Request of Additional Information.

Resolving Different Opinions and Interpretations

Best Practices for a Q-submission

Best Practices for a 510(k) Preparation, Submission and Clearance

Speaker’s Practical, Actionable and Sustainable Solutions (PASS)

Conclusions

Who Will Benefit:

Regulatory Affairs Teams

Research & Development Teams

QA/QC/QS

CROs

Consultants

Contractors / Subcontractors

Senior Management

Anyone interested in 510(k) matters

Price Tags:

Live

Single Live : For One Participant

$ 249

Corporate Live : For Max. 10 Participants

$ 899

Recording

Single REC : For One Participant - Unlimited Access for 6 Months

$ 299