Accurate FDA Consultants provides our clients guidance through the entire regulatory submission process, we can assist you no matter what stage you are in.

We are third party experts in Regulatory, Quality and Compliance Consulting that help Medical Device and IVD firms with managing their regulatory submissions from planning Pre-Submissions to submitting 510(k) premarket submissions. We also have experience with Class 3 medical devices and handle Premarket Approvals (PMA) and their associated reporting requirements such as supplements and annual reports.

We provide the following Regulatory Services:

Medical Devices and IVD Submissions

• Pre-Submissions (Pre-subs/Q-Subs/Submission Issue Requests (SIR)
• Pre-Market Notifications (510(k)
• 513(g) Request for Classification
• Investigational Device Exemption (IDE)
• Pre-Market Approval (PMA)
• PMA Supplements (30-day/135-day, 180-day, Real Time, Special, Panel Track)
• PMA Annual Reports

Experienced U.S. Agent – Registration and Listing Accurate Consultants continues to serve a multitude of satisfied foreign medical device and pharmaceutical clients around the world, as their US Agent. We can register your establishment and list your products. We will serve as your conduit between your firm and the FDA, to schedule inspections and intercept custom disputes and issues.