Regulatory Open Forum

Dear all:

I have a question about the FDA Guidance: Providing Postmarketing Periodic Safety Reports in the ICH E2C(R2) Format (Periodic Benefit-Risk Evaluation Report) Guidance for Industry.
Is this guidnace for Drugs only? Or is it applicable for Medical device as well? Which FDA guidance/regulation is for postmarket periodic safety report of medical device?

Thank you
XinLin 

CDER and CBER issued this guidance document and it applies to the medical products they regulate. It does not apply to products that CDRH regulates.

CDRH has a different system that, in general, does not require postmarket periodic safety reports. The exception is the, so called, 522 studies. 522 is the section of the law that authorizes FDA to do this. The regulations are in Part 822-Postmarket Surveillance. If the regulation applies to the device manufacturer, FDA will send a letter invoking Part 822.<o:p></o:p>

Dear all:

I have a question about the FDA Guidance: Providing Postmarketing Periodic Safety Reports in the ICH E2C(R2) Format (Periodic Benefit-Risk Evaluation Report) Guidance for Industry.
Is this guidnace for Drugs only? Or is it applicable for Medical device as well? Which FDA guidance/regulation is for postmarket periodic safety report of medical device?

Thank you
XinLin 

CDER and CBER issued this guidance document and it applies to the medical products they regulate. It does not apply to products that CDRH regulates.

CDRH has a different system that, in general, does not require postmarket periodic safety reports. The exception is the, so called, 522 studies. 522 is the section of the law that authorizes FDA to do this. The regulations are in Part 822-Postmarket Surveillance. If the regulation applies to the device manufacturer, FDA will send a letter invoking Part 822.<o:p></o:p>

Dear all:

I have a question about the FDA Guidance: Providing Postmarketing Periodic Safety Reports in the ICH E2C(R2) Format (Periodic Benefit-Risk Evaluation Report) Guidance for Industry.
Is this guidnace for Drugs only? Or is it applicable for Medical device as well? Which FDA guidance/regulation is for postmarket periodic safety report of medical device?

Thank you
XinLin 

CDER and CBER issued this guidance document and it applies to the medical products they regulate. It does not apply to products that CDRH regulates.

CDRH has a different system that, in general, does not require postmarket periodic safety reports. The exception is the, so called, 522 studies. 522 is the section of the law that authorizes FDA to do this. The regulations are in Part 822-Postmarket Surveillance. If the regulation applies to the device manufacturer, FDA will send a letter invoking Part 822.<o:p></o:p>

Dear all:

I have a question about the FDA Guidance: Providing Postmarketing Periodic Safety Reports in the ICH E2C(R2) Format (Periodic Benefit-Risk Evaluation Report) Guidance for Industry.
Is this guidnace for Drugs only? Or is it applicable for Medical device as well? Which FDA guidance/regulation is for postmarket periodic safety report of medical device?

Thank you
XinLin 

Dear all:

I have a question about the FDA Guidance: Providing Postmarketing Periodic Safety Reports in the ICH E2C(R2) Format (Periodic Benefit-Risk Evaluation Report) Guidance for Industry.
Is this guidnace for Drugs only? Or is it applicable for Medical device as well? Which FDA guidance/regulation is for postmarket periodic safety report of medical device?

Thank you
XinLin