Aware Date - What's the definition of Aware Date in plain English - 21 CFR Part 803.3

[rose24m03]

What's the definition of Aware Date in plain English (please, no direct quote from FDA web site) in regards to Medical Device Reporting requirement? Just want to confirm if we have the same interpretation as the rest of the industry or if it is a difference of opinion between our interpretation and the FDA Inspector's. Thanks.

[Wes Bucey]

In Reply to Parent Post by rose24m03

What's the definition of Aware Date in plain English (please, no direct quote from FDA web site) in regards to Medical Device Reporting requirement? Just want to confirm if we have the same interpretation as the rest of the industry or if it is a difference of opinion between our interpretation and the FDA Inspector's. Thanks.

There is an FDA document
Guidance for Industry - Medical Device Reporting - Alternative Summary Reporting (ASR) Program

which contains the quote:
This is the date that the manufacturer became aware of an adverse reportable event and is defined under 21 CFR Part 803.3(c).
this seems pretty straightforward to me.

The point some guys try to hang their hat on is "constructive ignorance" when they say, "I didn't expect this event and so I wasn't looking for it. Now that you brought it to my attention, I'll do something about it."
when the REAL fact is they knew all along but made a point of not officially recording that knowledge in a "don't ask, don't tell" attitude. FDA guys really go berserk if they think the manufacturer is "gaming" them.

The guidance document is here:
http://www.fda.gov/cdrh/osb/guidance/315.html

[rose24m03]

BECOMES AWARE [§803.3(c)]

Manufacturers are considered to have "become aware" of an MDR reportable event when:

any employee becomes aware of a reportable event required to be reported within 30 days, or required to be reported within 5 days pursuant to a written request from FDA; or
any employee who is a person with management or supervisory responsibilities over persons with regulatory, scientific, or technical responsibilities, or a person whose duties relate to the collection and reporting of adverse events, becomes aware that a reportable event, from any information, including any trend analysis, necessitates remedial action to prevent an unreasonable risk of substantial harm to public health.

FDA believes these time frames for reporting should be triggered when employees of the reporting entities become aware of events. FDA believes that manufacturers have a direct responsibility to inform all employees to forward immediately adverse event information to the appropriate person designated by the manufacturer as responsible for MDR reporting.

[Wes Bucey]

Right! Employers are responsible for seeing that employees know about and follow regulations.

As Deming says, Management is RESPONSIBLE for everything.

Short of secret sabotage, I don't see any excuse for management to allow ANY breakdown in communication between them and employees in ensuring employees understand and conform to the regulations. Similarly, management has a duty to stay in the loop about any and all events which may be subject to regulatory requirements.

So - tell us the way your organization is interpreting this regulation and what FDA representative has said in regard to that interpretation.

(As an aside, you should be aware that FDA is not always right and has lost some rancorous cases at trial.)

[Al Rosen]

The "aware date" is the date any employee has been told of the problem. So, if today a customer tells a salesman about a problem he encountered with a device, the clock starts today. The company has 30 days from today to submit a report for a reportable event.

[rose24m03]

All information below are fictional, for the purpose of discussion on what is really the "Aware Date":

An alleged product failure was reported by the user facility (e.g. hospital) to the manufacturer on 3/1/05, the date of the event. No injuries or death resulted. Per established complaint handling process, a complaint was opened for this alleged failure on 3/1/05 to initiate investigations. Company service engineer was dispatched to the user facility immediately to interview the user(s) and to examine the device.

Initial investigations (e.g. telnet to the device location to check sequence of actions that took place leading to the alleged failure) revealed that the device has functioned as intended per design controls process, with all mitigations (e.g. primary, secondary safety features and so forth) in place per risk management documentation. Review of component and device history from various quality data sources (e.g. DHR of this device unit, NCR data from manufacturing and component repair facilities, trended complaint data from the year this device was first manufactured, service data on this device at this user facility, device manuals including installation and servicing documentation, etc) revealed that there were no same or similar allegations in the past and device was installed and serviced as per manuals. No abnormal service history on this device was observed.

Competent panel of cross functional members (e.g. engineering, customer support, manufacturing, manufacturing QA, clinical and technical support, compliance, etc) reviewed all initial investigation results with QARA (who is responsible for the collection and reporting of adverse events) on 3/25/05. All agreed that based on investigation results gathered thus far the device has functioned as intended and that there is no risk of substantial harm posed to the public health. Thus, it was determined that this is not a reportable event per 803. All deliberation discussions and supporting evidence reviewed were documented and on file with the complaint record. Note: Company service engineer ordered a replacement subassembly on 3/1/05 and swapped the subassembly on-site on 3/3/05. Subassembly removed from the user facility was in transit to be returned to the company's manufacturing location for examination and testing (e.g. by Engineering to attempt to reproduce the alleged failure).

Subassembly was received at the company's manufacturing location on 3/9/05. Subassembly was examined and tested at the system level on 3/10/05 with the sequence of actions (commands that the user facility was performing leading to the alleged product failure on 3/1/05) using another device unit (manufacturing equivalent) in-house. Alleged failure was reproducible. Rigorous analysis was initiated on the subassembly level and at the component levels to identify the root cause(s). A few components were identified as possible initial root causes.

To make the story shorter, eventually on 4/5/05 all further investigation results became available from both in-house and suppliers, confirming product failure at the subassembly level (caused by 1 component). Panel of cross-functional members reviewed and analyzed these new investigation results with QARA on 4/5/05. All agreed that based on the new information the device has malfunctioned and concluded that this would be a reportable event now. Action plans were finalized. MDR was filed and C&R was initiated on 4/6/05. Component was re-designed and released through ECO process on 4/9/05. All in-house forward production used the re-designed component. Any devices shipped prior (including the complainant site) were corrected via FCO process. Again, all deliberation discussions and supporting evidence reviewed were documented and on file with the complaint record.

Now, if you are the QARA in this fictional example, what date would you use as the “aware date” to be compliance with MDR (i.e. page 31 of Medical Device Report for Manufacturer http://www.fda.gov/cdrh/manual/mdrman.pdf). Why do you feel the date you pick is the correct “aware date”? Based on the “aware date” you pick, are MDR and C&R filed on-time?

[Al Rosen]

The date after you initially received the report is the date the clock starts, regardless of when you were able to confirm the malfunction.

Accordingly, FDA generally considers that a manufacturer becomes aware of an adverse event whenever any employeebecomes aware of an adverse event. The 30-day time frame begins the day after receipt of the information that reasonably suggests that an MDR reportable event has occurred.

I think that you made a good faith effort and that at worst you filed the report 6 days late. Are you in a spitting contest?

[rose24m03]

Here's the 803.3 definition on Become Aware:

"Become aware means that an employee of the entity required to report has acquired information that reasonably suggests a reportable adverse event has occurred."