REGULAR CONTENT
Final ID
606
Type
Educational Exhibit-Poster Only
Authors
D Mina1, P Nadendla1, G Siskin1, M Englander1, A Malhotra1, A Herr1, K Mandato1, L Keating1
Institutions
1Albany Medical Center, Albany, NY
Purpose
To review the regulations behind the off-label medical device use in Interventional Radiology and to make interventional radiologists aware of the limitations of these regulations.
Materials & Methods
The United States FDA is responsible for clearing or approving medical devices to be used for specific indications. Given the rapid pace of development within Interventional Radiology, it is not uncommon for existing devices to be used for 'off-label' indications. This was most recently supported within the Food and Drug Administration Modernization Act of 1997 but is not without its limitations, which largely lie within the areas of commercialization and research.
Results
This exhibit will review the statutes that define the ability of a physician to use a legally marketed medical device for an off-label indication. It will review the circumstances in which this is and is not permissible. Specifically, it will review the limitations as they concern commercialization (including the perception of commercialization on social media and practice/department websites) and research (including the differentiation between prospective and retrospective studies evaluating off-label medical device use). Finally, this exhibit will discuss the role of industry and the limitations placed upon medical device manufacturers and their representatives in this area.
Conclusions
The off-label use of medical devices has historically been and will likely continue to be an important part of Interventional Radiology practice. By definition, the innovation that sets this field aside from others almost mandates creativity with existing devices. This exhibit will enable interventional radiologists to understand the rationale behind this use and will raise awareness of the limitations that must always be considered.
Final ID
606
Type
Educational Exhibit-Poster Only
Authors
D Mina1, P Nadendla1, G Siskin1, M Englander1, A Malhotra1, A Herr1, K Mandato1, L Keating1
Institutions
1Albany Medical Center, Albany, NY
Purpose
To review the regulations behind the off-label medical device use in Interventional Radiology and to make interventional radiologists aware of the limitations of these regulations.
Materials & Methods
The United States FDA is responsible for clearing or approving medical devices to be used for specific indications. Given the rapid pace of development within Interventional Radiology, it is not uncommon for existing devices to be used for 'off-label' indications. This was most recently supported within the Food and Drug Administration Modernization Act of 1997 but is not without its limitations, which largely lie within the areas of commercialization and research.
Results
This exhibit will review the statutes that define the ability of a physician to use a legally marketed medical device for an off-label indication. It will review the circumstances in which this is and is not permissible. Specifically, it will review the limitations as they concern commercialization (including the perception of commercialization on social media and practice/department websites) and research (including the differentiation between prospective and retrospective studies evaluating off-label medical device use). Finally, this exhibit will discuss the role of industry and the limitations placed upon medical device manufacturers and their representatives in this area.
Conclusions
The off-label use of medical devices has historically been and will likely continue to be an important part of Interventional Radiology practice. By definition, the innovation that sets this field aside from others almost mandates creativity with existing devices. This exhibit will enable interventional radiologists to understand the rationale behind this use and will raise awareness of the limitations that must always be considered.