Accelerated Device Approval Services LLC ("ADAS") can review your 510(k) application, instead of the FDA. We review, on behalf of the FDA, various low-risk medical devices. The FDA´s recommendations on what to include within your 510(k) application are summarized in our “510(k) Format” webpage, which has been helpful to many applicants.
The average 510(k) that uses ADAS to perform a Third-Party Review receives a 510(k) clearance within only 49 days. One of the reasons for the accelerated timeline is because your reviewer at ADAS will be someone who is familiar with your type of device and how it is used in clinical practice. In fact, most of our current reviewers 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.
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 of our identified 510(k) 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 (a)(2)(B) of 21 U.S.C. 360m.
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 for 510(k) applications. 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 them out and e-mail both forms 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