Regulatory Open Forum

Hello,

In 2013, FDA came up with a proposed rule to revise medical device and biological product labeling to explicitly allow for the inclusion of stand-alone graphical representation (symbols) provided they are standardized symbols.

1) Can anyone provide input if this rule has been finalized? I could not find any update.
2) In the meantime (if not finalized), is FDA accepting draft labeling as a part of Submissions? Please share your experience with FDA

Thank you

-------------------------------------------
Shiven Gandhi
Regulatory Affairs Specialist
Medtronic
San Francisco CA
United States
-------------------------------------------

Hello Shiven, 

The guidance has not yet been finalized. Per my most recent interaction with CDRH, explanatory text is still required for product labels associated with marketing submissions although they are not as strict with product under IDE. 

-------------------------------------------
Diane King RAC
VP, Regulatory Affairs
Gynesonics Inc.
Redwood City CA
United States
-------------------------------------------


Original Message:
Sent: 02-24-2015 12:11
From: Shiven Gandhi
Subject: Use of Certain Symbols in Labeling (Federal Register Colume 78 Issue 76)

Hello,

In 2013, FDA came up with a proposed rule to revise medical device and biological product labeling to explicitly allow for the inclusion of stand-alone graphical representation (symbols) provided they are standardized symbols.

1) Can anyone provide input if this rule has been finalized? I could not find any update.
2) In the meantime (if not finalized), is FDA accepting draft labeling as a part of Submissions? Please share your experience with FDA

Thank you

-------------------------------------------
Shiven Gandhi
Regulatory Affairs Specialist
Medtronic
San Francisco CA
United States
-------------------------------------------

Thank you everyone for your feedback. 

-------------------------------------------
Shiven Gandhi
Regulatory Affairs Specialist
-------------------------------------------


Original Message:
Sent: 02-25-2015 10:48
From: Diane King
Subject: Use of Certain Symbols in Labeling (Federal Register Colume 78 Issue 76)

Hello Shiven, 

The guidance has not yet been finalized. Per my most recent interaction with CDRH, explanatory text is still required for product labels associated with marketing submissions although they are not as strict with product under IDE. 

-------------------------------------------
Diane King RAC
VP, Regulatory Affairs
Gynesonics Inc.
Redwood City CA
United States
-------------------------------------------


Original Message:
Sent: 02-24-2015 12:11
From: Shiven Gandhi
Subject: Use of Certain Symbols in Labeling (Federal Register Colume 78 Issue 76)

Hello,

In 2013, FDA came up with a proposed rule to revise medical device and biological product labeling to explicitly allow for the inclusion of stand-alone graphical representation (symbols) provided they are standardized symbols.

1) Can anyone provide input if this rule has been finalized? I could not find any update.
2) In the meantime (if not finalized), is FDA accepting draft labeling as a part of Submissions? Please share your experience with FDA

Thank you

-------------------------------------------
Shiven Gandhi
Regulatory Affairs Specialist
Medtronic
San Francisco CA
United States
-------------------------------------------

Shiven,

FDA couldn't offer when to expect to finalize it.  But it is recommended to "follow the current rules in place by placing adjacent explanatory text next to the symbols you are using on your device and labeling."

During 2013 public meeting, I in fact presented.  There was a regulatory professional who presented after me in 2013. Her husband passed away due to labeling issues of the medical product.  Thus, as a cautionary note, if your firm decides to go creative, extra care should be exercised.

____________________________________________________________
Dr. David Lim, Ph.D., RAC, ASQ-CQA 


Original Message:
Sent: 02-24-2015 12:11
From: Shiven Gandhi
Subject: Use of Certain Symbols in Labeling (Federal Register Colume 78 Issue 76)

Hello,

In 2013, FDA came up with a proposed rule to revise medical device and biological product labeling to explicitly allow for the inclusion of stand-alone graphical representation (symbols) provided they are standardized symbols.

1) Can anyone provide input if this rule has been finalized? I could not find any update.
2) In the meantime (if not finalized), is FDA accepting draft labeling as a part of Submissions? Please share your experience with FDA

Thank you

-------------------------------------------
Shiven Gandhi
Regulatory Affairs Specialist
Medtronic
San Francisco CA
United States
-------------------------------------------