REGULATORY SOLUTIONS

We provide the following
expert Regulatory Services.

EXPERIENCED US AGENT

Accurate Consultants continues to serve a multitude of satisfied foreign medical device clients around the world, as their US Agent. We assure your compliance with the new medical device requirements for foreign manufacturers (21 CFR 807.40- effective 2/11/02). We also can serve as the client’s Official Correspondent. In any case, we act as your conduit between your firm and the FDA.

An owner or operator of a foreign establishment who initiates or develops specifications for a medical device; and/or manufactures, assembles, processes, repackages or re-labels medical devices for human use; or is an initial importer of medical devices must register the establishment and submit listing information for those devices that are in commercial distribution. The initial registration and listing must be submitted within 30 days of the start of operations at the establishment.

ANNUAL FEES:

US AGENT: Our modest annual US Agent fee must be renewed each year. This fee is required for either completing the initial registration form (FDA 2891) or submitting an annual registration update (FDA 2891a) by either the client or Accurate Consultants. We are listed with the FDA as US Agents. See link: www.accessdata.fda.gov/scripts/cdrh/cfdocs

DEVICE LISTING: In addition, we can provide the FDA with your device listing information (FDA-2892) for a modest one-time fee per device. The device listing must be submitted with the initial registration form and notification of US Agent letter.

REGULATORY SUBMISSIONS

Accurate Consultants provides clients guidance through the entire application preparation and submission process, or can write and submit several types of regulatory submission on behalf of the client. Our consultants have both industry experience in preparing submissions and have an excellent track record for helping domestic and international firms achieve their regulatory objectives.

Please contact us for quotes for any of the following Medical Device submissions:

a) Pre Market Notification-510 (k)
b) Investigational Device Exemption (IDE)
c) Pre Market Application (PMA)
d) Device Master File (DMF)

FDA RESPONSES AND CORRECTIVE ACTION PLANS: Accurate Consultants has experience in both FDA 483 and Warning Letter Responses. We assess both the inspection team and notes, and assist in deriving the appropriate response to each specific 483. In addition, we are experts at assembling a corrective action master plan, in order to meet all regulatory commitments according to schedule.

In addition, we are experienced in developing product recallstrategies and assisting in drafting an appropriate health hazard analysis, when needed.
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