Navigating the regulatory landscape can be daunting and frustrating for anybody involved in medical device research and development. MPSS was launched in May 2014, to assists Vanderbilt investigators with regulatory affairs related issues, and help bring innovative medical devices out of their laboratories and into the marketplace. MPSS provides individualized or large audience teaching and lectures in relation to medical device regulatory affairs.
MPSS can help determine if your product is regulated by the FDA and if so, how. This is very useful as FDA determination will affect the development pathway as well as the requirements for the type and amount of data to support safety and efficacy.
Please contact us and we will be happy to set up a meeting and provide guidance as per your need and product.
- Individualized consultation on your medical device
- Device classification
- Applicable regulations, guidance documents and standards
- Navigating the IRB and FDA process
- Strategies and guidance for submissions
- When to contact and interact with the IRB and the FDA
- o Support with the development of the clinical study protocol and consent form
- Reporting
- Early product development regulatory guidance
- Guidance for pre-clinical testing requirements
- Guidance for benefit - risk assessment
- Determination of need for Early Feasibility IDE
- Risk assessment for SR / NSR guidance
- Informal communication and interaction with the FDA to get early input to regulatory strategies
- Guidance for who to call and what to say
- Facilitate and participate in meetings
- FDA pre-submission and IDE guidance and support
- Guidance on when pre-submission is useful and what information will be needed.
- Assist with addressing FDA responses and concerns on submissions
- Assist with IDE submissions
- Review draft submissions
- Assist with understanding the IDE and documentation requirements
- Assist with maintenance and reporting post-IDE approval
- Support for regulatory documentation
- Provision and maintenance of Sponsor-Investigator Initiated Device Research Handbook
- Provision of IDE templates and tools
- Assist with device risk assessment and documentation
- Guidance for using the Vanderbilt Quality Management System to meet FDA IDE requirements
- Take part in grants as consultants or co-investigators
- Provide project regulatory assistance and guidance
- Support investigators with grant submissions through review of drafts