Why should my company participate? What are the tangible benefits from CDRH? When do I recognize them?
CfQ VIP can be a method to drive improvements such as:
- Increased manufacturing and product confidence
- Faster time to market
- Better information to drive regulatory decisions
- Improved resource allocation
- A continuous improvement focus on what is most important to patients
As the result of additional granularity and the commitment to transparency, FDA is modifying certain regulatory activities to support participants in the Program to bring innovative devices to market. FDA will forgo routine and risk-based inspections for those facilities that have committed to completing a Medical Device Discovery Appraisal by signing a Statement of Work for the appraisal with CMMI Institute.
Additionally, after appraisal results have been submitted to the FDA, participants will be eligible for streamlined submissions and reviews for the following PMA supplements:
- 30-Day Notices
- Site Transfer
- PMA Original manufacturing module
- FDA may also forego pre-approval inspections
The FDA will also benefit from this program by potentially reducing the internal resources required for evaluation of inspections, improving consistency of the review, and having access to enhanced data analytics of quality performance. The increased FDA capacity can be used for manufacturers who have not demonstrated high capability and to engage earlier in the development life cycle of new products.
The benefits provided can also accelerate the implementation of quality improvements at a faster rate and reduce time to market of product improvements and enhancements for patients.