12 Dec New FDA Guidance for Medical Device Reporting for Manufacturers
On November 8, 2016, the FDA issued the long awaited final guidance, “Medical Device Reporting for Manufacturers.” http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm359566.pdf The final guidance addresses medical device reporting and recordkeeping requirements for device-related adverse events and certain types of device malfunctions. The guidance supersedes the 2013 draft guidance, as well as the 1997 MDR guidance document.
The final guidance provides clarification on several key issues related to MDR reporting by breaking them down into a question and answer format and including helpful examples to make clear their position. Some areas highlighted by the FDA as key issues are:
- When a firm “becomes aware” that an MDR reportable event has occurred.
- MDR submission rules involving a marketed device studied under an investigational device exemption (IDE).
- MDR submission rules involving adverse events that occur outside the United States.
- Exemption request process for MDR reporting for a contract manufacturer
- Clarification of the submission of 5-day reports and remedial actions.
- Clarification on the 2-year presumption for reportable malfunctions.
The FDA provided further clarification on these key issues in a webinar presented on November 30th http://www.fda.gov/downloads/Training/CDRHLearn/UCM531013.pdf :
A. ‘Becoming Aware’
A firm becomes ‘aware’ of an event whenever:
- Any of their employees become aware of information that reasonably suggests that an event is required to be reported in a 30-day report or in a 5-day report that the FDA request from you; or
- Any of their employees with management or supervisory responsibilities over persons with regulatory, scientific or technical responsibilities (including consultants or contractors) or whose duties relate to the collection and reporting of adverse events, becomes aware from any information (including any trend analysis) that an MDR reportable event(s) necessitates remedial action to prevent an unreasonable risk of substantial harm to the public health.
B. MDRs for IDE Situations
- If a device is legally marketed in the US and is also under an Investigational Device Exemption (IDE), any adverse event that involves the investigational use of the marketed device is subject to reporting under both the IDE regulation and the MDR regulation. (APPLIES TO NON-INVESTIGATIONAL DEVICE)
- If the device is under study it should be reported under the IDE only. (21 CFR Part 812) (APPLIES TO INVESTIGATIONAL DEVICE)
- If a marketed device is used as an investigational device (i.e. under a new indication for use), and if the adverse event results from the labeled marketed use of the device, it must be reported as an MDR.
- If the device is on the market in the US and is being studied under an IDE e.g. for a new indication, and the device is used outside of the IDE (either US or OUS) for the investigational indication (i.e., “off-label” use), and a complaint associated with this off-label use becomes known, then this complaint must be evaluated for reporting under § 803.
C. MDRs from Outside the US (OUS)
- If a foreign event occurs, this chart specifies the MDR reporting obligation of the foreign event.
Market Status in US
Market Status in OUS Country
Report Foreign Event
|US||NO||YES||YES, when requested|
|OUS||Under Study||YES||YES (only if a similar device marketed in US by the same manufacturer)*|
*Similar device – devices that are assigned the same FDA product code are considered by FDA to be similar for the purposes of the MDR requirements of 21 CFR §803.
D. Exemption Request for Contract Manufacturer
- Any firm that initiates specifications for devices that are manufactured by a second party for subsequent distribution by the person initiating the specifications.
- A contract manufacturer who does not distribute or market the devices it manufacturers for a specifications developer would not have an MDR reporting obligation and would not require an exemption.
- If the contract manufacturer markets the devices that it manufacturers, then both the contract manufacturer and the specifications developer have MDR reporting obligations.
- If either the contract manufacturer or specifications developer wants to report on behalf of the other, an exemption is needed.
E. 5-Day Reports and Remedial Action
- A “remedial action” is any action, other than routine maintenance or servicing of a device, necessary to prevent recurrence of an MDR reportable event. FDA does not consider an action taken to correct only a single device involved in an MDR reportable event to be a remedial action.
- Not all MDR reportable events requiring remedial actions need to be submitted as 5-day reports. Only events that require remedial actions to prevent an unreasonable risk of substantial harm to the public health or events for which FDA requests such a report must be submitted as 5-day reports.
- When the remedial action taken is not required to address an unreasonable risk of substantial harm to the public health the reportable adverse events should be submitted as 30-day reports instead of 5-day reports.
F. 2-Year Presumption
- An MDR guidance for manufacturers issued in 1997 stated that once a malfunction has caused or contributed to a death or serious injury, a presumption that the malfunction is likely to cause or contribute to a death or serious injury has been established.
- This presumption will continue until either the malfunction has caused or contributed to no further deaths or serious injuries for two years, or the manufacturer can show through valid data that the likelihood of another death or serious injury as a result of the malfunction is remote.
Generally, the final guidance suggests the FDA is taking a more rigorous view of medical device reporting requirements and enforcement action. It also provides manufacturers insight into the Agency’s intent via the Q&A format and examples provided in the guidance.
How Can BBA Help You
Now that the final guidance document has been published, manufacturers of medical devices may need to review and revise their reporting procedures where necessary. Boston Biomedical Associates has extensive experience assisting companies in meeting Medical Device Reporting requirements. We can help your company interpret the MDR reporting requirements and assist in post approval compliance activities, as well as pre- and post-market complaint handling.