Medical Device Reporting - Remedial Action Exemption; Guidance for Industry and FDA

What are the criteria for the Remedial Action Exemption (RAE)?
As a medical device manufacturer, you may request an exemption from the requirement to report certain adverse events associated with medical device remedial actions, if all of the following conditions apply:

(1) You submit an RAE notification to us. Your RAE notification must be filed with or after submission of one or more 5-day or 30-day initial reports on events that are subject to a remedial action to be covered under this exemption. Your MDR report(s) must be filed within the required timeframe and cannot be delayed in order to be included in an RAE notification. You cannot utilize this exemption until at least one applicable MDR report is sent to us. All required baseline reports must also be filed with the 5-day or 30-day report.

(2) You notify the appropriate FDA District Office of the remedial action prior to or at the time of submission of the RAE notification.

(3) You conduct a complete complaint investigation as required by the Quality System Regulation (21 CFR 820).

(4) Your RAE notification references this exemption and states that future incidents meeting all of the conditions will not be reported to us. Your notification should include all of the following information:

(a) the identity of the FDA District Office that you informed (including the name and address of the person contacted ) about the remedial action,

(b) the date and method used to inform the District Office,

(c) a description of the nature of the notification to customer, such as a letter,

(d) the range of device model numbers, catalog numbers, serial numbers, or lot numbers covered by the remedial action,

(e) a complete description of the reported problem, including specific components as appropriate, that adequately explains why the product is undergoing a remedial action, and

(f) the manufacturer MDR report number(s) for the initial 5-day or 30-day MDR report filed for the remedial action, or a statement that the MDR that triggered the 5-day or 30-day report is attached to the RAE.