Regulatory Open Forum

Hello Victor,

Thank you very much for your response. Yes. I did read up on Parts 803.21 in the CFR. Our director of Sales posed me this question yesterday & wanted to know if this agreement covers FDA requirement​.  This is an agreement that I was told we send out to our dealers.

"Without limiting the foregoing, Dealer agrees to maintain written records of, and to immediately notify XXXX in writing of any of the following events about which Dealer receives information or becomes aware of from any source: (i) any potential or actual malfunction of a Product; (ii) any accident involving, or any death, illness or  injury potentially caused by or related to, the use of any Product; (iii) any other event which requires Dealer to provide notice as set forth in published policies or procedures distributed by XXXX from time to time; or (iv) any other event that XXXX may be required to report under any applicable law or regulation.  Dealer agrees to provide XXXX the written notice required by this subsection G.(i) through (iv) by no later than one (1) business day after it becomes aware of any such event (an event referenced in subsection G.(i) through (iv) will be referred to herein as an "Event").  Dealer further agrees that in addition to the written notice required pursuant to this subsection G, upon receiving information or becoming aware of an Event occurring pursuant to subsection (i) or (ii) above, Dealer will also immediately notify XXXXX by calling XXXXs Call Center at (XXX) XXX-XXXX.  Dealer will cooperate with XXX in the investigation of any Event, or possible Event, occurring in the Territory, whether or not Dealer first gave XXXX notice of the Event.  Dealer agrees to maintain the written records required by this subsection G., including, without limitation, records of communications, whether oral or written, relating to such information, for a period of three (3) years after Dealer first received such information."

I am trying to figure out where they are getting the 1 business day reporting in case of an adverse event & where they are getting the 3 year time period as to how long they need to retain records (by the dealer). 21 CFR 803.21 states user facility, does that include dealers? My company is a medical device manufacturer. The director wanted to know if our dealer agreement is FDA compliant. I am still fairly new to this company & new to Regulatory. My background was mainly Quality.

Thanks,
Vicki

Hello Victor,

Thank you very much for your response. Yes. I did read up on Parts 803.21 in the CFR. Our director of Sales posed me this question yesterday & wanted to know if this agreement covers FDA requirement​.  This is an agreement that I was told we send out to our dealers.

"Without limiting the foregoing, Dealer agrees to maintain written records of, and to immediately notify XXXX in writing of any of the following events about which Dealer receives information or becomes aware of from any source: (i) any potential or actual malfunction of a Product; (ii) any accident involving, or any death, illness or  injury potentially caused by or related to, the use of any Product; (iii) any other event which requires Dealer to provide notice as set forth in published policies or procedures distributed by XXXX from time to time; or (iv) any other event that XXXX may be required to report under any applicable law or regulation.  Dealer agrees to provide XXXX the written notice required by this subsection G.(i) through (iv) by no later than one (1) business day after it becomes aware of any such event (an event referenced in subsection G.(i) through (iv) will be referred to herein as an "Event").  Dealer further agrees that in addition to the written notice required pursuant to this subsection G, upon receiving information or becoming aware of an Event occurring pursuant to subsection (i) or (ii) above, Dealer will also immediately notify XXXXX by calling XXXXs Call Center at (XXX) XXX-XXXX.  Dealer will cooperate with XXX in the investigation of any Event, or possible Event, occurring in the Territory, whether or not Dealer first gave XXXX notice of the Event.  Dealer agrees to maintain the written records required by this subsection G., including, without limitation, records of communications, whether oral or written, relating to such information, for a period of three (3) years after Dealer first received such information."

I am trying to figure out where they are getting the 1 business day reporting in case of an adverse event & where they are getting the 3 year time period as to how long they need to retain records (by the dealer). 21 CFR 803.21 states user facility, does that include dealers? My company is a medical device manufacturer. The director wanted to know if our dealer agreement is FDA compliant. I am still fairly new to this company & new to Regulatory. My background was mainly Quality.

Thanks,
Vicki