Compliance Notes

by Anna Longwell, Esq.

Compliance Note: Device Export (continued)

The Regulations

The recordkeeping requirement of section 801, and the notice requirement of section 802 have been addressed by regulations. These regulations were effective June 19, 2002. FDA has said (docket) they will exercise “enforcement discretion” with respect to the regulation describing documentation showing a product is “not in conflict” with the laws of the importing country. (Letter, Jul 22, 2002, Margaret M. Dotzel, FDA to Peter Barton Hutt, Docket 98N05831). However, all other regulations are now enforceable with respect to drug and device products. A summary of the device portion of the regulations at 21 CFR 1.101 follows.

The record retention period for these records is identical to the retention time for QSR documents, but the time starts at the date of exportation. The reason for this is that FDA expects these records could (not must) be part of the firm’s QSR records. Recordkeeping at 1.101(b) relates to compliance with the provisions of 801(e)(1). Since 510(k) and PMA export products must comply with these requirements, they have fairly general application for device exports.

First, there must be records demonstrating the product meets the foreign purchaser’s specifications. In their preamble, FDA has pointed out that the specifications need not be detailed, but should specify a particular product and a particular amount of product. For example, an order for 5,000 bottles of 50 tablets each of drug x at a dose of 50 mg/tablet, would be considered sufficient to determine the user’s specification.

Next, there must be documentation that the product does not conflict with the laws of the importing country. This is the regulation that has caused so much controversy. Currently, the regulation offers two choices for such documentation. Either the company must have a letter from an official of the foreign government indicating the product complies, or at least is “not in conflict” with local law. Otherwise, a responsible company employee in the US (and thus under FDA jurisdiction) must supply a notarized certification that the product does not conflict with the laws of the importing country, AND acknowledge that he/she is aware of the US fraud statutes. (Author’s note: Although I have worked in global companies with excellent ex-US regulatory staff, I would hesitate to sign such a document without personal understanding of the laws and regulations involved.)

Third, there must be copies of the labels on the outside of the package that says “for export only”, or, if there is no outside package, shipping documents with this statement.

Finally, there must be records demonstrating that the product is not sold in the United States, such as production and shipping records for the particular product, indicating that exports+scrap+quarantine for future export = total production, or if similar products are sold in the US, US promotional material for the line, with the specific exported product absent.

In addition, for products exported under 802 (PMA products), there are additional recordkeeping requirements, described in 1.101(e). For these products, there must be records identifying the product’s trade name, the type of device, the model number, the consignee’s name and address, and the date exported and the quantity exported. Note: these records must be at the manufacturer’s site, not (only) at your export broker’s office.

The notification regulations, at 21 CFR 1.101(d), give the content of the notification, which, for devices, includes the trade name and type of device, the model number, and if the destination country is not a listed country, the name of the country. If the export is intended for a listed country, it is not necessary to include any information about the destination country. For devices, the notification is sent to Division of Program Operations (HFZ-305) CDRH, FDA, 2094 Gaither Road. Rockville, MD 20850.

Some guidance follows.

Revised Compliance Policy Guide 7150.01
Draft Export Guidance 63 FR 32219 ff. (1998): somewhat opaque, probably out-of-date
Regulations: Notification and Recordkeeping Requirements 65 FR 65429 ff. (2001): Preamble is good.