Creating a Comprehensive Regulatory Plan
A comprehensive regulatory plan involves addressing many elements ranging from the relatively simple to the complex. A comprehensive regulatory plan should address:
- Intended use and indications for the product
- Key product claims and how they will be supported
- Possible predicate devices/products
- Country specific regulatory pathways
- Product classification in targeted countries
- Labeling requirements
- Pertinent regulatory guidance documents
- Standards and directives
- Biocompatibility testing
- Preclinical studies
- Clinical studies
- Manufacturing sites
- Export requirements and/or conditions
- Possible regulatory risks
- Contingency plans