- Email: [email protected]
Regulatory Issues
m
uite frequently a manufacturer will be asked questions from clinicians about the use and performance of their IV catheters which are problematic. While they are perfectly appropriate questions, the manufacturer may not be in a position to answer completely due to the regulatory status of the device in question. While I was working in the regulatory area for an IV catheter company, one of the questions asked most often was whether the catheter was "approved" by the FDA. The answer for any medical device is no; that is the FDA does not approve any medical device. The FDA reviews the use and construction of medical devices, but when it grants the company to market the device, the letter granting such action states that the company "may not promote or in any way represent [its] device or its labeling as being approved by the FDA." The preferred route for gaining marketing clearance from the US FDA is via a process termed the 51O(k) application. So named from paragraph 510 and subsection k of the Medical Device Amend-
ments to the Federal Food, Drug and Cosmetic Act in which the specifics of this process are explained; the essential point to be made is that your device is substantially equivalent to one or more devices currently on the market. The new device must be shown to be substantially equivalent in three areas: (1) the intended use, (2) characteristics of the device (e.g., length, outer diameter, material composition), and (3) safety and effectiveness. Once these points are satisfied typically (but not always) the FDA will allow the device to be marketed with no further testing or without clinical studies. Preparing a 510(k) application is sometimes more art than science, with the manufacturer disclosing what is necessary for the FDA to make a comparison to the currently marketed devices and yet not disclOSing manufacturing or other aspects which would be of value to the competition. The FDA did provide a guidance document covering short-term and long-term intravascular catheters in draft form back in 1994 and, while it has not been made formal, it is
INTERNET
a good road map for a company wishing to enter or expand its role in the IV catheter market. This guidance document requires information on the physical specifications (e.g., dimensions, flow rate, proximal and distal end configuration), mechanical specifications (e.g., tensile strength, tip attachment strength, burst pressure), biocompatibility, and chemical composition of any coatings (e.g., antimicrobial). In addition copies of proposed labeling, instructions for use, and advertisements are provided. Labeling is often the area which gives clinicians and manufacturers the most trouble. Typically the customer has asked a specific question about the use of the catheter. The manufacturer has information/data to support such a use but cannot specifically endorse it because it falls outside the indications for use or other performance standard reviewed under the 51ack) application. For example, most IV catheter manufacturers like their devices to be viewed as capable of remaining indwelling for extended periods of time, and most clinicians wish to
RESOURCES
Center for Devices and Radiological Health, US FDA
www.fda.gov/edrh Centers for Disease Control
www.ede.gov Regulatory Affairs Professionals Society's Resource Center
www.medmarket.eom/tenants/raps/serviees/rre.htm I Medical Device Link
www.devieelink.eom Wilson Sonsini Goodrich and Rosati's resource page
www.wsgrgate.wsgr.eom/resourees/FDA/FDAalert 36
~VAD
Sp r i ng
I9 9 8
uite frequently a manufacturer will be asked questions from clinicians about the use and performance of their IV catheters which are problematic. While they are perfectly appropriate questions, the manufacturer may not be in a position to answer completely due to the regulatory status of the device in question. While I was working in the regulatory area for an IV catheter company, one of the questions asked most often was whether the catheter was "approved" by the FDA. The answer for any medical device is no; that is the FDA does not approve any medical device. The FDA reviews the use and construction of medical devices, but when it grants the company to market the device, the letter granting such action states that the company "may not promote or in any way represent [its] device or its labeling as being approved by the FDA." The preferred route for gaining marketing clearance from the US FDA is via a process termed the 51O(k) application. So named from paragraph 510 and subsection k of the Medical Device Amend-
ments to the Federal Food, Drug and Cosmetic Act in which the specifics of this process are explained; the essential point to be made is that your device is substantially equivalent to one or more devices currently on the market. The new device must be shown to be substantially equivalent in three areas: (1) the intended use, (2) characteristics of the device (e.g., length, outer diameter, material composition), and (3) safety and effectiveness. Once these points are satisfied typically (but not always) the FDA will allow the device to be marketed with no further testing or without clinical studies. Preparing a 510(k) application is sometimes more art than science, with the manufacturer disclosing what is necessary for the FDA to make a comparison to the currently marketed devices and yet not disclOSing manufacturing or other aspects which would be of value to the competition. The FDA did provide a guidance document covering short-term and long-term intravascular catheters in draft form back in 1994 and, while it has not been made formal, it is
INTERNET
a good road map for a company wishing to enter or expand its role in the IV catheter market. This guidance document requires information on the physical specifications (e.g., dimensions, flow rate, proximal and distal end configuration), mechanical specifications (e.g., tensile strength, tip attachment strength, burst pressure), biocompatibility, and chemical composition of any coatings (e.g., antimicrobial). In addition copies of proposed labeling, instructions for use, and advertisements are provided. Labeling is often the area which gives clinicians and manufacturers the most trouble. Typically the customer has asked a specific question about the use of the catheter. The manufacturer has information/data to support such a use but cannot specifically endorse it because it falls outside the indications for use or other performance standard reviewed under the 51ack) application. For example, most IV catheter manufacturers like their devices to be viewed as capable of remaining indwelling for extended periods of time, and most clinicians wish to
RESOURCES
Center for Devices and Radiological Health, US FDA
www.fda.gov/edrh Centers for Disease Control
www.ede.gov Regulatory Affairs Professionals Society's Resource Center
www.medmarket.eom/tenants/raps/serviees/rre.htm I Medical Device Link
www.devieelink.eom Wilson Sonsini Goodrich and Rosati's resource page
www.wsgrgate.wsgr.eom/resourees/FDA/FDAalert 36
~VAD
Sp r i ng
I9 9 8