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In the medical device arena, pre-market approval (PMA) submissions to the FDA keep taking longer and longer to process, according to Bob Rhatigan, senior vice president of facial aesthetics for Allergan.
"A decade ago we used to see a PMA approval time of 9-12 months," Mr. Rhatigan told attendees of the Summit in Aesthetic Medicine sponsored by Skin Disease Education Foundation (SDEF). "In the middle of the last decade, that increased to 16 months, and as recently as 2010, that time frame is over 2 years. It's something that we are anxiously watching. We don't see any signs of that abating."
The implications are gloomy for clinicians engaged in research of medical devices who wish to continue working in the United States. The current regulatory environment, Mr. Rhatigan said, "is working to push clinical research and studies outside of the U.S. market. It is not inconceivable, looking forward, to think about the bulk if not all of clinical research moving offshore as a result of companies like Allergan needing to get products approved more quickly. We are a bit pessimistic right now but [are] attempting to influence [legislators], as we want to make sure innovation in this industry continues to be ripe in the U.S. market."
SDEF and this news organization are owned by Elsevier.
-- Doug Brunk
In the medical device arena, pre-market approval (PMA) submissions to the FDA keep taking longer and longer to process, according to Bob Rhatigan, senior vice president of facial aesthetics for Allergan.
"A decade ago we used to see a PMA approval time of 9-12 months," Mr. Rhatigan told attendees of the Summit in Aesthetic Medicine sponsored by Skin Disease Education Foundation (SDEF). "In the middle of the last decade, that increased to 16 months, and as recently as 2010, that time frame is over 2 years. It's something that we are anxiously watching. We don't see any signs of that abating."
The implications are gloomy for clinicians engaged in research of medical devices who wish to continue working in the United States. The current regulatory environment, Mr. Rhatigan said, "is working to push clinical research and studies outside of the U.S. market. It is not inconceivable, looking forward, to think about the bulk if not all of clinical research moving offshore as a result of companies like Allergan needing to get products approved more quickly. We are a bit pessimistic right now but [are] attempting to influence [legislators], as we want to make sure innovation in this industry continues to be ripe in the U.S. market."
SDEF and this news organization are owned by Elsevier.
-- Doug Brunk
In the medical device arena, pre-market approval (PMA) submissions to the FDA keep taking longer and longer to process, according to Bob Rhatigan, senior vice president of facial aesthetics for Allergan.
"A decade ago we used to see a PMA approval time of 9-12 months," Mr. Rhatigan told attendees of the Summit in Aesthetic Medicine sponsored by Skin Disease Education Foundation (SDEF). "In the middle of the last decade, that increased to 16 months, and as recently as 2010, that time frame is over 2 years. It's something that we are anxiously watching. We don't see any signs of that abating."
The implications are gloomy for clinicians engaged in research of medical devices who wish to continue working in the United States. The current regulatory environment, Mr. Rhatigan said, "is working to push clinical research and studies outside of the U.S. market. It is not inconceivable, looking forward, to think about the bulk if not all of clinical research moving offshore as a result of companies like Allergan needing to get products approved more quickly. We are a bit pessimistic right now but [are] attempting to influence [legislators], as we want to make sure innovation in this industry continues to be ripe in the U.S. market."
SDEF and this news organization are owned by Elsevier.
-- Doug Brunk