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Feb 22 2011

A Brief Update on FDA’s Re-evaluation of the 510(k) Process

FDA 510k Cleared Medical DevicesChange is in the air.  No, I’m not referring to the recent thaw here in Minnesota, but rather to the looming changes in the regulations governing medical devices in the U.S.

First, a brief primer on the medical device approval process in the U.S.  Currently, all novel medical devices must be approved through a “de novo” review process known as the Premarket Approval (PMA) process.  In situations for which a PMA is not required, a 510(k), also called a Premarket Notification (PMN), is the application process through which a sponsor demonstrates “that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device”.  Through this process, FDA, specifically the Center for Devices and Radiological Health (CDRH), determines whether the new device is equivalent to a device already placed into one of the three classification categories, otherwise known as a predicate device.  The 510(k) process has been the mechanism by which over 3,000 medical devices have been brought to market in the U.S. but has come under increasing scrutiny by regulators as they face backlash over recalled devices that were approved through the 510(k) process.

Tapped as director of CDRH in January 2010, Dr. Jeffrey Shuren is spearheading the effort to re-evaluate the 510(k) approval process.  Shuren, who thus far has proven to be a proactive leader, and his colleagues have the unenviable task of maintaining the balance between retaining the U.S.’s leadership status in medical device innovation while assuring that devices are safe and effective.  Shuren has noted that the point of the changes was not to reduce the number of devices that use the 510(k) program, but rather to create “a smarter 510(k) program”.  In a wise and well-received move, Shuren and his colleagues held several town-hall style meetings in cities with high densities of medical device companies where attendees were allowed to voice concerns and pose questions directly to the top officials in the division.

Although FDA is working to clarify the approval process for devices, one consequence of the uncertainty surrounding the regulations in the U.S. is an increased enthusiasm toward developing medical devices in Europe.  Despite claims by the FDA that there is a safety benefit from the slower, more rigorous regulatory process in the U.S., a new report titled “EU Medical Device Approval Safety Assessment” conducted by the Boston Consulting Group and paid for by the Advanced Medical Technology Association concludes that there is no material difference between the regulatory regimes in the U.S. and Europe, from a safety perspective. This has fueled the device industry’s claims that the overly burdensome regulatory environment in the U.S. is resulting in the erosion of the U.S.’s leadership position in the industry.  Stephen J. Ubl, president and CEO of Advamed, the industry council for the American medical device industry, noted “It’s well-documented that it takes longer to bring medical technology to market in the U.S. than it does in Europe.  [The Boston Consulting Group] report suggests that the delay denies patients access to the most up-to-date treatments and cures without a corresponding increase in safety”.  One notable caveat to the study was that, because of the de-centralized nature of the E.U.’s regulatory system and differences in terminology used by regulatory bodies, a direct comparison between device recall data in the U.S. and the E.U. is not possible.  Either way the outcome of the study does little to change the industry-accepted view that the E.U. offers a quicker path to market for medical devices compared to the U.S.

However, the facts surrounding device recalls shed additional light on FDA’s concerns over the current 510(k) processes as it relates to the safety of marketed devices.

According to a new report from the Archives of Internal Medicine, nearly three-quarters of medical device recalls that could have caused injury or death from 2005-2009 were approved through the 510(k) process.  The report’s authors argue the study findings are proof that high-risk devices should not be cleared for market using the quicker and less stringent 510(k) process and should instead be reviewed in the more thorough and costly PMA program.

The process for developing the new guidance began with a release of proposed changes from FDA in August 2010 and was followed by a 60-day public comment period.  FDA is currently addressing the comments and modifying the proposed guidance.  As a result of significant responses to their initial proposal, nearly half of the 55 changes the agency recommended were temporarily taken off the table.  Among those were several of the most controversial elements, such as the ability to revoke 510(k) clearances, increased post-market surveillance and the establishment of a new classification for medical devices that would require the submission of clinical evidence.  The net effect, viewed by many as an overwhelming victory for the device industry, was a far less onerous set of changes.  The tabling of several changes viewed as burdensome to industry will likely reduce the chances of FDA making a significant overhaul of the program in the near future.  The FDA announced that it plans to make 25 changes to its 510(k) program this year; however, these changes are pending the results of a separate Institute of Medicine committee report scheduled for release this summer.  The committee will assess whether the 510(k) clearance process sufficiently protects patients and promotes public health.  Specifically, the IOM committee will answer two principal questions:

  1. Does the current 510(k) process optimally protect patients and promote innovation in support of public health?
  2. If not, what legislative, regulatory, or administrative changes are recommended to optimally achieve the goals of the 510(k) process?

Until then, sponsors should begin planning to implement the changes that may apply to their development programs and to keep an eye on the CDRH weathervane.

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Change is in the air. No, I’m not referring to the recent thaw here in Minnesota, but rather to the looming changes in the regulations governing medical devices in the U.S.

 

First, a brief primer on the medical device approval process in the U.S. Currently, all novel medical devices must be approved through a “de novo” review process known as the Premarket Approval (PMA) process. In situations for which a PMA is not required, a 510(k), also called a Premarket Notification (PMN), is the application process through which a sponsor demonstrates “that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device”.[MSOffice1] Through this process, FDA, specifically the Center for Devices and Radiological Health (CDRH), determines whether the new device is equivalent to a device already placed into one of the three classification categories, otherwise known as a predicate device. The 510(k) process has been the mechanism by which over 3,000 medical devices have been brought to market in the U.S. but has come under increasing scrutiny by regulators as they face backlash over recalled devices that were approved through the 510(k) process.

 

Tapped as director of CDRH in January 2010, Dr. Jeffrey Shuren, is spearheading the effort to re-evaluate the 510(k) approval process. Shuren, who thus far has proven to be a proactive leader, and his colleagues have the unenviable task of maintaining the balance between retaining the U.S.’s leadership status in medical device innovation while assuring that devices are safe and effective. Shuren has noted that the point of the changes was not to reduce the number of devices that use the 510(k) program, but rather to create “a smarter 510(k) program”. In a wise and well-received move, Shuren and his colleagues held several town-hall style meetings in cities with high densities of medical device companies where attendees were allowed to voice concerns and pose questions directly to the top officials in the division.

 

Although FDA is working to clarify the approval process for devices, one consequence of the uncertainty surrounding the regulations in the U.S. is an increased enthusiasm toward developing medical devices in Europe. Despite claims by the FDA that there is a safety benefit from the slower, more rigorous regulatory process in the U.S., a new report titled “EU Medical Device Approval Safety Assessment” conducted by the Boston Consulting Group and paid for by the Advanced Medical Technology Association concludes that there is no material difference between the regulatory regimes in the U.S. and Europe, from a safety perspective.[MSOffice2] This has fueled the device industry’s claims that the overly burdensome regulatory environment in the U.S. is resulting in the erosion of the U.S.’s leadership position in the industry. Stephen J. Ubl, president and CEO of Advamed, the industry council for the American medical device industry, noted “It’s well-documented that it takes longer to bring medical technology to market in the U.S. than it does in Europe. [the Boston Consulting Group] report suggests that the delay denies patients access to the most up-to-date treatments and cures without a corresponding increase in safety”. One notable caveat to the study was that, because of the de-centralized nature of the E.U.’s regulatory system and differences in terminology used by regulatory bodies, a direct comparison between device recall data in the U.S. and the E.U. is not possible. Either way the outcome of the study does little to change the industry-accepted view that the E.U. offers a quicker path to market for medical devices compared to the U.S.

 

However, the facts surrounding device recalls shed additional light on FDA’s concerns over the current 510(k) processes as it relates to the safety of marketed devices.

 

According to a new report from the Archives of Internal Medicine, early three-quarters of medical device recalls that could have caused injury or death from 2005-2009 were approved through the 510(k) process.[MSOffice3] The report’s authors argue the study findings are proof that high-risk devices should not be cleared for market using the quicker and less stringent 510(k) process and should instead be reviewed in the more thorough and costly PMA program.

 

The process for developing the new guidance began with a release of proposed changes from FDA in August 2010[MSOffice4] and was followed by a 60-day public comment period. FDA is currently addressing the comments and modifying the proposed guidance. As a result of significant responses to their initial proposal, nearly half of the 55 changes the agency recommended were temporarily taken off the table.[MSOffice5] Among those were several of the most controversial elements, such as the ability to revoke 510(k) clearances, increased post-market surveillance and the establishment of a new classification for medical devices that would require the submission of clinical evidence. The net effect, viewed by many as an overwhelming victory for the device industry, was a far less onerous set of changes. The tabling of several changes viewed as burdensome to industry will likely reduce the chances of FDA making a significant overhaul of the program in the near future. The FDA announced that it plans to make 25 changes[MSOffice6] to its 510(k) program this year; however, these changes are pending the results of a separate Institute of Medicine committee report scheduled for release this summer.[MSOffice7] The committee will assess whether the 510(k) clearance process sufficiently protects patients and promotes public health. Specifically, the IOM committee will answer two principal questions:

 

1) Does the current 510(k) process optimally protect patients and promote innovation in support of public health?

2) If not, what legislative, regulatory, or administrative changes are recommended to optimally achieve the goals of the 510(k) process?

 

Until then, sponsors should begin planning to implement the changes that may apply to their development programs and to keep an eye on the CDRH weathervane.


 

[MSOffice1]http://www.fda.gov/medicaldevices/deviceregulationandguidance/howtomarketyourdevice/premarketsubmissions/premarketnotification510k/default.htm

 

[MSOffice2]http://www.medcitynews.com/2011/01/does-europe-offer-faster-better-approach-than-fda-on-medical-devices/

 

[MSOffice3]http://archinte.ama-assn.org/cgi/content/full/archi

Change is in the air.  No, I’m not referring to the recent thaw here in Minnesota, but rather to the looming changes in the regulations governing medical devices in the U.S.

First, a brief primer on the medical device approval process in the U.S.  Currently, all novel medical devices must be approved through a “de novo” review process known as the Premarket Approval (PMA) process.  In situations for which a PMA is not required, a 510(k), also called a Premarket Notification (PMN), is the application process through which a sponsor demonstrates “that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device”.[MSOffice1] Through this process, FDA, specifically the Center for Devices and Radiological Health (CDRH), determines whether the new device is equivalent to a device already placed into one of the three classification categories, otherwise known as a predicate device.  The 510(k) process has been the mechanism by which over 3,000 medical devices have been brought to market in the U.S. but has come under increasing scrutiny by regulators as they face backlash over recalled devices that were approved through the 510(k) process.

Tapped as director of CDRH in January 2010, Dr. Jeffrey Shuren, is spearheading the effort to re-evaluate the 510(k) approval process.  Shuren, who thus far has proven to be a proactive leader, and his colleagues have the unenviable task of maintaining the balance between retaining the U.S.’s leadership status in medical device innovation while assuring that devices are safe and effective.  Shuren has noted that the point of the changes was not to reduce the number of devices that use the 510(k) program, but rather to create “a smarter 510(k) program”.  In a wise and well-received move, Shuren and his colleagues held several town-hall style meetings in cities with high densities of medical device companies where attendees were allowed to voice concerns and pose questions directly to the top officials in the division.

Although FDA is working to clarify the approval process for devices, one consequence of the uncertainty surrounding the regulations in the U.S. is an increased enthusiasm toward developing medical devices in Europe.  Despite claims by the FDA that there is a safety benefit from the slower, more rigorous regulatory process in the U.S., a new report titled “EU Medical Device Approval Safety Assessment” conducted by the Boston Consulting Group and paid for by the Advanced Medical Technology Association concludes that there is no material difference between the regulatory regimes in the U.S. and Europe, from a safety perspective.[MSOffice2] This has fueled the device industry’s claims that the overly burdensome regulatory environment in the U.S. is resulting in the erosion of the U.S.’s leadership position in the industry.  Stephen J. Ubl, president and CEO of Advamed, the industry council for the American medical device industry, noted “It’s well-documented that it takes longer to bring medical technology to market in the U.S. than it does in Europe.  [the Boston Consulting Group] report suggests that the delay denies patients access to the most up-to-date treatments and cures without a corresponding increase in safety”.  One notable caveat to the study was that, because of the de-centralized nature of the E.U.’s regulatory system and differences in terminology used by regulatory bodies, a direct comparison between device recall data in the U.S. and the E.U. is not possible.  Either way the outcome of the study does little to change the industry-accepted view that the E.U. offers a quicker path to market for medical devices compared to the U.S.

However, the facts surrounding device recalls shed additional light on FDA’s concerns over the current 510(k) processes as it relates to the safety of marketed devices.

According to a new report from the Archives of Internal Medicine, early three-quarters of medical device recalls that could have caused injury or death from 2005-2009 were approved through the 510(k) process.[MSOffice3] The report’s authors argue the study findings are proof that high-risk devices should not be cleared for market using the quicker and less stringent 510(k) process and should instead be reviewed in the more thorough and costly PMA program.

The process for developing the new guidance began with a release of proposed changes from FDA in August 2010[MSOffice4] and was followed by a 60-day public comment period.  FDA is currently addressing the comments and modifying the proposed guidance.  As a result of significant responses to their initial proposal, nearly half of the 55 changes the agency recommended were temporarily taken off the table.[MSOffice5] Among those were several of the most controversial elements, such as the ability to revoke 510(k) clearances, increased post-market surveillance and the establishment of a new classification for medical devices that would require the submission of clinical evidence.  The net effect, viewed by many as an overwhelming victory for the device industry, was a far less onerous set of changes.  The tabling of several changes viewed as burdensome to industry will likely reduce the chances of FDA making a significant overhaul of the program in the near future.  The FDA announced that it plans to make 25 changes[MSOffice6] to its 510(k) program this year; however, these changes are pending the results of a separate Institute of Medicine committee report scheduled for release this summer.[MSOffice7] The committee will assess whether the 510(k) clearance process sufficiently protects patients and promotes public health.  Specifically, the IOM committee will answer two principal questions:

1)   Does the current 510(k) process optimally protect patients and promote innovation in support of public health?

2)   If not, what legislative, regulatory, or administrative changes are recommended to optimally achieve the goals of the 510(k) process?

Until then, sponsors should begin planning to implement the changes that may apply to their development programs and to keep an eye on the CDRH weathervane.

nternmed.2011.30

 

[MSOffice4]http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm221166.htm

 

[MSOffice5]http://www.massdevice.com/news/update-industry-reacts-proposed-changes-510k-program

 

[MSOffice6]http://massdevi.server265.com/podcast/510%28K%29_Implementation_Chart.pdf

 

[MSOffice7]http://www.massdevice.com/news/fda-announces-510k-changes

 

http://www.iom.edu/Activities/PublicHealth/510KProcess.aspx

This is a post by Shane Grivna, Ph.D.  Shane is a Clinical Strategy Scientist for Cato Research and an Analyst for Cato BioVentures.