A company may ship a product in its final packaging to a contract sterilizer. The final packaging declares the product as sterile, but it hadn’t been sterilized yet. This potential violation could result in a misbranded product.
FDA regulations (21 CFR §801.150(e)) provide a control mechanism that allows this kind of shipment in interstate commerce. Under §801.150(e)(1), manufacturers and sterilizers may sign an agreement containing the following:
- Instructions for maintaining accountability of the number of units in each shipment;
- Acknowledgment that the devices that are nonsterile are being shipped for further processing; and
- Specifications for sterilization processing.
The parties must keep a copy of the agreement (21 CFR §801.150(a)(2)), for at least two years after the final shipment under the agreement. FDA Inspectors may review these records as part of an inspection.
Please review these regulations for the specific details. You can read the regulation at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm
Following the Paperwork Reduction Act, the FDA submitted information on the burden required to create and keep the records required by this part of the regulation.
FDA estimates that companies involved will generate the {§801.150(e)} records 20 times each year, and that each record will take 4 hours to prepare; this is a cost of 80 hours per year. In addition, the FDA estimates that record maintenance {§801.150(a)(2)} takes 0.5 hours per record; this is a total cost of 10 hours per year.
The total cost for these records is 90 hours per year.