Via Federal Express
June 6, 2008
[CITY, STATE ZIP]
Your company has been identified as having listed Analyte Specific Reagents (ASRs) with the Food and Drug Administration (FDA) [product code MVU]. As you may be aware, the Food and Drug Administration (FDA) published a guidance document entitled “Guidance for Industry and FDA Staff Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions1” on September 14, 2007 in order to clarify the roles and responsibilities of ASR manufacturers. The Federal Register notice announcing the availability of this guidance document stated “Manufacturers should ensure their Class II or Class III in vitro diagnostic devices, that are currently inappropriately labeled and marketed as ASRs, comply with the law by September 15, 2008.” (http://www.fda.gov/OHRMS/DOCKETS/98fr/E7-18108.pdf )
FDA appreciates that there are products that have been inappropriately marketed as ASRs that are widely used by clinical laboratories. Although modification of products inappropriately marketed as ASRs so that they are brought within the scope of the ASR definition (21 CFR 21 CFR 864.4020) is an option to reach compliance, we believe that, in most cases, clearance or approval of products in their existing configurations is in the best interest of the public health.
In order to minimize disruption of laboratory testing, FDA is willing to work with manufacturers that intend to make premarket submissions to bring their products that are currently inappropriately labeled and marketed as ASRs into compliance. If you manufacture such products and are unable to obtain product clearance or approval for such products by September 15, 2008, we encourage you to make a pre-IDE submission to FDA before that date which includes a clear plan for each device with a premarket time line for submission and a detailed outline of the intended use and studies/data that are planned for the premarket submission(s).
For devices with Pre-IDEs received before September 15, we intend to work interactively with manufacturers to reach agreement on a premarket submission plan and in those cases where agreement is reached in a timely manner, we intend to notify you that the premarket submission plan is acceptable. Where manufacturers have reached agreement with us on a submission and, going forward, continue to meet the goals of the agreed-upon timeline, we intend to continue to exercise enforcement discretion until the device is cleared or approved
If we cannot reach agreement on an acceptable plan, or if you do not pursue that plan in good faith, then we may take enforcement action with respect to the affected products.
We are committed to working with you as we strive to protect the public health without imposing unnecessary regulatory burdens on the marketing of products of potential clinical importance. If you have any questions, please call the Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) at 240-276-0450.
Steven I. Gutman, M.D., M.B.A.
Office of In Vitro Diagnostic Device
Evaluation and Safety
Center for Devices and Radiological Health