Al is correct...unless you sell to Europe as well as US. According to the Medical Device Directive Annex II 6.1, all quality records shall be kept minimum 5 years from the date when the last product was manufactured. According to CFR Part 820 all records apart from, management review, supplier audits/evaluations and internal audits shall be retained for a period of time equivalent to the design and expected life of the device, but in no case less than 2 years from the date of release for commercial distribution by the manufacturer.