FDA 510(k) Third Party Review
The FDA 510(k) Third Party Review Program is designed to streamline the evaluation process for medical device manufacturers seeking FDA 510(k) clearance. This program aims to alleviate the FDA's administrative workload and expedite the decision-making process.
Under this program, accredited FDA Third Party Assess Organizations are authorized to review low-to-moderate risk medical devices, providing manufacturers with a voluntary alternative review method. By delegating the review of lower-risk devices to third-party organizations, the FDA can focus its resources on higher-risk devices, ensuring faster 510(k) decisions without compromising quality.
Participation in this program is voluntary, and approximately 50% of qualifying 510(k) submissions are accepted. There is no separate payment required to the FDA; the fee for the review is determined through an agreement between the 510(k) submitter and the chosen 3P510k Review Organization.
To submit your file through the FDA Third Party Review Organization, follow these four basic steps:
Determine Eligibility: Check the eligibility of your device by reviewing the list of eligible devices for the product code, searching the FDA's Device Classification Database, contacting a Third-Party review organization (3P510k), or reaching out to the FDA directly at 3P510k@fda.hhs.gov.
Find and Contact a 3P510k Review Organization: Use the List of Devices for FDA Third Party Review page to locate organizations that can review your 510(k) submission. Explore the product codes and regulation names, along with the contact information of eligible 3P510k review organizations.
Obtain Price Quotes and Make a Contract: Request price quotes from one or more 3P510k review organizations and establish a contract for the review. The fee for the review is determined between the submitter and the Review Organization, with no user fee collected by the FDA for third-party submissions.
Submit the 510(k) to the 3P510k Review Organization: Prepare the submission by including a letter authorizing the 3P510k review organization to discuss the 510(k) with the FDA and forward it on your behalf. Provide the organization's name, contact information of the assigned reviewer, and the device trade name. Include the complete 510(k) submission with supporting data, summaries, and analysis in the format requested by the 3P510k review organization.
The 3P510k Review Organizations adhere to the same evaluation standards used by the FDA. They ensure compliance with the most recent standards and recommendations applicable to the device type, often involving early involvement with the FDA and potential requests for additional information. Once the 3P510k Review Organization completes its review and provides all necessary documentation, including the original 510(k) submission and their recommendation of substantially equivalent (SE) or not substantially equivalent (NSE), the FDA makes the final determination within 30 days of receiving the recommendation.
Accelerate your FDA 510(k) clearance process with the efficient and effective FDA Third Party Review Program. Take advantage of this opportunity to navigate the complex regulatory landscape more swiftly, ensuring your medical device reaches the market faster while maintaining the highest standards of safety and efficacy.