Product Evaluation Policy

The product evaluation policy ensures that surgeon owned distributors have a formal program in place to review and qualify Vendors, and to review and analyze the quality and value of implants prior to supplying those implants to customers. Where applicable, this process includes ensuring adherence to a contracted hospital’s value analysis program prior to introduction and use of products.

Vendor Qualification

The distributorship shall review and qualify each Vendor prior to purchasing any products from that Vendor. Vendor qualification shall specifically include, but not be limited to, the following:

1. Evidence of valid, current product liability and completed operations insurance with minimum limits of $1,000,000 per occurrence, $2,000,000 aggregate
2. Evidence of valid FDA entity registration and FDA compliant quality systems
3. Review of FDA database information, including product recalls, notices, warning letters, or any other relevant product or company information
4. Vendor is not on the debarred listing

Product Selection and Assessment

All products shall be subject to the following procedures prior to being approved for purchase and sale. Product acceptance shall require:

1. Product design features that are established by the surgeons
2. Evidence of FDA approval or 510k clearance by means of official documents
3. Comparison summary of comparable implants to include design attributes, functionality, performance, and mechanical testing if published
4. References of other surgeons currently using the products, if appropriate