Medical Device Regulation - Itamar Levy and Associates, PLLC

Medical Device Regulation


Medical Device Regulation

The development, manufacturing, and marketing of a medical device require an in-depth understanding of the FDA regulatory process, as well as the ability to interact effectively with FDA personnel. Our firm offers comprehensive counseling and advocacy on FDA medical device matters, ranging from product clearance and approval to postmarket requirements and enforcement/compliance issues, product promotion, and advertising issues. We work with medical device regulation in the US and international markets.

Quality Assurance – Quality Management System

Medical device manufacturers need to incorporate and effective Quality Management System. At our firm we pride ourselves on designing a Quality Management System that complies with current FDA and ISO regulations.

Our risk governance services include:

• Develop a risk model based on the appropriate guidelines that reflect the industry, company and product profiles
• Implement the governance models to include training of staff
• Streamline compliance efforts by focusing resources in proportion to defined risk, e.g., validation, procedures and training
• Assess validation documentation, identify gaps and recommend remediation steps, time frame and costs
• Review Standard Operating Procedures (SOPs) for regulatory coverage and completeness
• Perform an assessment of a specific software product or regulatory process

Consulting and Periodic Reviews

Periodic document review is a proactive quality practice that effectively decreases risk.. Intermittent document review ensures critical systems are in an effective state of compliance and up to date with current FDA regulations and guidelines. Periodic Reviews can be an effective double check of a company’s risk and compliance performance. Additionally, these intermittent reviews provide the opportunity to re-evaluate current practices and serve as a forum for improvement.

Areas that are most often included in a Periodic Review program include:

• Validation Deliverables
• Change Control Documentation
• Standard Operating Policy and Procedures
• Design and Development of Products
• Training Records
• Quality Agreements

Regulatory Training

A critical component of managing business risk is ensuring that your organization has the resources and training necessary to maintain regulatory compliance. WE can devise specific training modules and courses for your company based on its needs.

Device Classification

If you intend to market a new medical device (or an existing device for a new use), it is important to figure out early on the class(es) to which your device will be assigned so that you can start planning and preparing for the type of premarketing submission/application (if any) and regulatory requirements applicable for the device.

Sometimes a device may be assigned to multiple regulatory classes for different intended uses, and you may be able to sell the device immediately for a particular use without a 510(k). This approach can be beneficial especially for a startup company who can start generating income from a device for one intended use while preparing and applying for a 510(k) for another use.

Our firm provides clients with product development counseling, including determining possible classification(s) and regulatory requirements for your product, to help you develop a regulatory strategy that best aligns with your business goals.

Product Clearance

If a 510(k) application needs to be filed for your device, we can work with you or a FDA consultant to put together the necessary application materials and file the application with FDA. Our firm can help you determine an appropriate predicate device(s) for your 510(k), and coordinate with investigators, research firms, contract manufacturers, and third parity reviewers, to conduct necessary safety and performance testing and analyses to support the 510(k) application materials.