FDA 510 K Submission - Wound Dressing - Wound Cleanser

The FDA's 510(k) clearance process is applicable to medical devices, including wound dressings, that are considered moderate-risk and have a substantially equivalent predicate device already on the market. Here are some key points to consider regarding FDA 510(k) requirements for wound dressings:

1. Predicate Device: To seek 510(k) clearance, you need to identify a predicate device that is already legally marketed in the United States. Your wound dressing should have similar intended use, technological characteristics, and performance to the predicate device.

2. Substantial Equivalence: The FDA requires you to demonstrate that your wound dressing is substantially equivalent to the predicate device in terms of safety and effectiveness. This typically involves providing data on materials, design, performance, and any differences or modifications made to the predicate device.

3. Preclinical Testing: Depending on the specific characteristics of your wound dressing, you may need to conduct preclinical testing to assess its biocompatibility, sterility, antimicrobial properties, and other relevant factors. The FDA expects appropriate testing methods and scientific data to support your claims.

4. Labeling and Instructions for Use: You must provide clear and accurate labeling and instructions for use with your wound dressing. This includes information on indications for use, contraindications, warnings, precautions, and directions for application and removal. It is crucial to ensure that the user can safely and effectively apply the dressing based on the provided instructions.

5. Manufacturing Controls: The FDA expects manufacturers to establish and follow good manufacturing practices (GMP) to ensure the consistency and quality of wound dressings. This includes proper control of raw materials, manufacturing processes, packaging, sterilization (if applicable), and quality assurance.

6. Submission and Review Process: To initiate the 510(k) process, you need to prepare and submit a comprehensive application to the FDA, including all relevant data, testing results, and documentation. The FDA will review the submission and may request additional information or clarification during the review process.

FDA Classification for Wound Dressing - Wound Cleanser

Regulation Number	Device Code	Device Class	Device Type
Unclassified	FRO	Unclassified	Dressing, Wound, Drug

LMG Provides assistance to wound dressing/wound cleanser manufacturers in FDA registration , 510k clearance, device listing, and US FDA Agent requirements.

Our experienced consultants can help you to comply with FDA requirements. Our expertise includes

• Prepare wound dressings 510k notification
• Submission of wound dressings 510k notification
• FDA Agent service for 510k submission
• Guidance in test requirements
• Register your establishment with FDA
• List your wound dressings with FDA.

Test Requirements for a wound dressings for US FDA 510K Submission

US FDA 510K Submission Requirements

FDA 510K Consultant