Under the Code of Federal Regulation 807.40(b) the Food and Drug Administration requires a foreign establishment to designate a United States Agent to act as their official correspondent.
Smith Associates has been serving the Medical Device Industry since 1994 assisting companies large and small in receiving Food and Drug Administration clearance for new devices.
We have a proven track record assisting medical device companies in regulatory compliance. As United States Agent for your company, we can ensure compliance with the new regulation, which became effective February 11, 2002.
The most common route to approval to market a medical device or biologic in the United States is the 510(k). It is the most cost effective means and is based on the claim of “substantial equivalence” or safety and efficacy of the device. The first and most important aspect of this procedure is to correctly classify your product. Based on this, all requirements for a successful filing will follow: intended use, technical data, and substantial equivalence.
Smith Associates will provide your company with the checklist for a complete submission. It will be our function to write the submission, based on information provided by your company and present a persuasive and convincing presentation of safety and effectiveness and substantial equivalence.
In most cases, this type of submission is an inclusive fixed fee.
Premarket approval is the FDA process to evaluate a Class III device. This classification has the most stringent review and is reserved for those devices or biologics that support or sustain human life, or may have substantial impact on human health, or present a potential for risk or illness. Class III devices are reviewed with exacting scrutiny by the FDA scrutiny by the FDA.
Smith Associates has the experience to guide your company through this process. As consultant for MedMira of Canada, MedMira has received their PMA for a Rapid HIV Test Kit.
An investigational device exemption allows manufacturers of devices to ship devices for use in a clinical evaluation. Involved in this process is an approved clinical, monitoring plan, IRB approval, etc. in order for the manufacturer to gather the clinical information on humans to establish the safety and effectiveness data.
Whatever the route required for your company’s medical product, Smith Associates is experienced in every aspect of the process
- Classification of product
- Required data both technical and descriptive for successful submissions acquired from the reviewing division to reflect the FDA’s “current thinking.”
- Preparation of the documentation
- Constructing a convincing substantial equivalence
- Negotiations for any responses necessary for approval
Smith Associates can assist manufactures of devices and in vitro diagnostic kits in the following quality system areas:
- Design Control
- cGMP Audit: Quality System Assessment
- FDA Inspections: Preparation
- FDA Inspections: Consultant Representation
- FDA inspection follow-up