Accelerated Device Approval Services LLC ("ADAS") can review your 510(k) application, on behalf of the FDA, as a Third-Party Reviewer for various low-risk medical devices. We are the most well-established Third-Party Reviewer making clearance decisions on 510(k) applications. For example, according to an independent poll by FDA-Insider.com, we are considered to be the best overall Third-Party Reviewer: http://www.fda-insider.com/top-third-party-reviewers.htm
The average 510(k) that we review receives a 510(k) clearance within only 49-days. One of the reasons for the quicker clearance timeline is because all our reviewers have regulatory experience in each medical device sector, such as Radiology and Gastroenterology. In fact, most of our current reviewers had previously worked as reviewers at the FDA.
The 510(k) filing fee is $9,000 to review and decide on whether your device is substantially equivalent to its designated predicate device. The FDA's recommendations on what to include within your 510(k) application are summarized in our “510(k) Format” webpage.
We will provide you with a list of all deficiencies in your 510(k) application within only 5-working days. Thereafter, you would have to resolve all our identified deficiencies - this step normally takes 14-days or less. The FDA then only has 30-days to assess our 510(k) decision memo for accuracy or any mistakes, as per section 21 U.S.C. 360m(a)(2)(B).
1. What are the advantages of conducting a 510(k) Third-Party Review with ADAS?
On average, our applicants can begin selling their device more than two months earlier than if they applied directly with the FDA. For example, according to page 173 of the FDA´s Quarterly Performance Review, the FDA takes an average of 131 days to decide on their 510(k) applications: https://www.fda.gov/media/115762/download
2. What are the 510(k) Third-Party Review Fees?
The 510(k) Third-Party Review filing fee is $9,000. There are no extra fees that you would owe to the FDA on your 510(k). The FDA officially waives its submission fee for all 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 by the FDA: 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. Fill out both Forms and e-mail them back to us at email@example.com. You can read more about the FDA's Third-Party Review program here: https://www.fda.gov/medical-devices/premarket-submissions/510k-third-party-review-program.
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
Vacutore Air/Water Bottle Tubing