Accelerated Device Approval Services LLC ("ADAS") conducts 510(k) reviews on behalf of the FDA for hundreds of different low-risk medical devices. Our 510(k) filing fee is $9,000 to review and decide on whether your device is substantially equivalent to your designated predicate.
By choosing ADAS to review your 510(k), we will conduct an accelerated review and provide you with a list of all deficiencies within 5-working days. If we decide that your 510(k) is substantially equivalent, then we would forward our decision to the FDA. The FDA only has 30-days to assess our review for accuracy, per section (a)(2)(B) of 21 U.S.C. 360m. You can read more about the Third-Party Review program here: https://www.fda.gov/medical-devices/premarket-submissions/510k-third-party-review-program
1. What are the advantages of conducting a 510(k) Third-Party Review with ADAS?
a. The FDA normally takes an average of 123-days to decide on a 510(k) application. See page 170 of the following FDA document: https://www.fda.gov/media/113207/download
However, the average 510(k) that uses ADAS to perform a Third-Party Review, receives a 510(k) clearance within only 49 days. In other words, on average, our applicants can begin selling their device more than two months earlier.
b. Your company benefits from directly interacting with a Third-Party Review by having easy access to your device´s 510(k) reviewer and resolve many deficiencies over the telephone. However, when you file your 510(k) directly through the FDA, you would then have to follow the time-consuming requirements of the FDA guidance on “Requesting FDA Feedback and Meetings” to set up a teleconference to discuss your 510(k) application with the FDA: https://www.fda.gov/media/114034/download
2. What are the 510(k) Third-Party Review Fees?
The 510(k) Third-Party Review filing fee is $9,000 for 510(k) applications. There are no extra fees or costs involved with your Third-Party Review for a 510(k) review. The FDA waives its submission fee for 510(k) Third-Party Reviews, as per section 738(a)(1)(B)(iv) of MDUFMA.
3. For which devices has ADAS been accredited to review by the FDA?
You can click on the following FDA weblink to view the different types of medical devices that ADAS has been accredited to review: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfThirdParty/Accredit.CFM?party_key=10
4. How do we get started with the Third-Party Review?
Download Form 8319 and Form 8320, which are shown below. Please fill them out and e-mail both Forms back to us at email@example.com
Life Sensor Cardiac Monitor https://www.accessdata.fda.gov/cdrh_docs/pdf19/K191331.pdf
Andorate Endoscope Channel Accessories https://www.accessdata.fda.gov/cdrh_docs/pdf19/K191231.pdf
Scope ProTech Endoscopic Storage Cover https://www.accessdata.fda.gov/cdrh_docs/pdf19/K191011.pdf