Recent Changes for "Federal Regulation of Prostheses" - Open Prosthetics Project Wiki

Federal Regulation of Prostheses

JonKuniholm — 2008-09-23 01:39:55

Differences for Federal Regulation of Prostheses

Deletions are marked with - .	Additions are marked with +.
Line 3:	Line 3:
- There are no regulations regarding custom parts made by prosthetic technicians and included in a completed prosthesis, or to customization of parts after distribution by a registered establishment. While it could be construed from the language in the exemption from the general controls above (which subject prosthetic limb component manufacture only to parts 820.198 and 820.180, and do not mention facility registration, included in the general controls), it is reasonable to assume that establishment registration is [http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?FR=807.65 required]. [http://www.oandp.com/products/trs/ TRS Inc.], or Therapeutic Recreation Systems Inc., run by amputee Bob Radocy in Colorado, for example, is [http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/Registration.cfm?ID=1849 registered] with owner/operator and registration number 1718966. Interestingly enough, the establishment registration requirement prohibits publishing or broadcasting the registration number in any way, presumably to avoid any suggestion that the establishment or the device has been approved by the FDA.	+ =Custom, Investigational or Experimental Devices= + There are no regulations regarding custom parts made by prosthetic technicians and included in a completed prosthesis, or to customization of parts after distribution by a registered establishment. While it could be construed from the language in the exemption from the general controls above (which subject prosthetic limb component manufacture only to parts 820.198 and 820.180, and do not mention facility registration, included in the general controls), it is reasonable to assume that establishment registration is [http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?FR=807.65 required]. [http://www.oandp.com/products/trs/ TRS Inc.], or Therapeutic Recreation Systems Inc., run by amputee Bob Radocy in Colorado, for example, is [http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/Registration.cfm?ID=1849 registered] with owner/operator and registration number 1718966. Interestingly enough, the establishment registration requirement prohibits publishing or broadcasting the registration number in any way, presumably to avoid any suggestion that the establishment or the device has been approved by the FDA. Prosthetic service providers routinely customize, modify and fabricate items for prosthetic use, and we are unaware of any that are registered as manufacturing establishments.
Line 5:	Line 6:
- =Investigational or Experimental Devices= - Because we are interested here at OPP in improving these devices, the obvious question arises: what about the testing of prototypes and their distribution to patients? Because we are dealing with a Class I (exempt) medical device that doesn't require a 510(k) submission, it could reasonably be argued that one need not do anything, because the rules governing [http://www.fda.gov/cdrh/devadvice/ide/index.shtml Investigational Device Exemptions (IDEs)] deal with the steps that must be taken in order to collect the data that must be submitted with the (not required) 510(k) application. These steps require that an [http://en.wikipedia.org/wiki/Institutional_review_board Institutional Review Board (IRB)] approve a study, consent, properly label the devices for investigational use, monitor the study, and maintain required records and reports. If these steps are complied with, the manufacturer need not even be a registered manufacturer as required above. It might reasonably be argued that for a device for which there are no requirements other than those outlined above, that a subset of these requirements might reasonably be complied with, e.g., consent the patients, label the devices, and maintain records and reports for the use of the devices.	+ Because we are interested here at OPP in improving these devices, the obvious question arises: what about the testing of prototypes and their distribution to patients? Because we are dealing with a Class I (exempt) medical device that doesn't require a 510(k) submission, it could reasonably be argued that one need not do anything, because the rules governing [http://www.fda.gov/cdrh/devadvice/ide/index.shtml Investigational Device Exemptions (IDEs)] deal with the steps that must be taken in order to collect the data that must be submitted with the (not required) 510(k) application. These steps require that an [http://en.wikipedia.org/wiki/Institutional_review_board Institutional Review Board (IRB)] approve a study, that the patients are consented, the devices properly labeled for investigational use, the study is monitored, and that required records and reports are maintained. If these steps are complied with, the manufacturer need not even be a registered manufacturer as required above. It might reasonably be argued that for a device for which there are no requirements other than those outlined above, that a subset of these requirements might reasonably be complied with, e.g.: consent the patients, label the devices, and maintain records and reports on the use of the devices. + + As we develop a procedure for dealing with this, we will make our decisions and documents available for others to use as a reference.

Federal Regulation of Prostheses

JonKuniholm — 2008-09-23 01:31:05

Differences for Federal Regulation of Prostheses

Deletions are marked with - .	Additions are marked with +.
Line 4:	Line 4:
	+ + =Investigational or Experimental Devices= + Because we are interested here at OPP in improving these devices, the obvious question arises: what about the testing of prototypes and their distribution to patients? Because we are dealing with a Class I (exempt) medical device that doesn't require a 510(k) submission, it could reasonably be argued that one need not do anything, because the rules governing [http://www.fda.gov/cdrh/devadvice/ide/index.shtml Investigational Device Exemptions (IDEs)] deal with the steps that must be taken in order to collect the data that must be submitted with the (not required) 510(k) application. These steps require that an [http://en.wikipedia.org/wiki/Institutional_review_board Institutional Review Board (IRB)] approve a study, consent, properly label the devices for investigational use, monitor the study, and maintain required records and reports. If these steps are complied with, the manufacturer need not even be a registered manufacturer as required above. It might reasonably be argued that for a device for which there are no requirements other than those outlined above, that a subset of these requirements might reasonably be complied with, e.g., consent the patients, label the devices, and maintain records and reports for the use of the devices.

Federal Regulation of Prostheses

JonKuniholm — 2008-01-09 18:28:50

Differences for Federal Regulation of Prostheses

Deletions are marked with - .	Additions are marked with +.
Line 1:	Line 1:
- In the United States, all upper and lower extremity prosthetic components are regulated as Class I (exempt) medical devices. The Federal Food and Drug Administration in the US (FDA), [http://www.fda.gov/cdrh/devadvice/3132.html classifies] medical devices as Class I, II or III. While most Class I devices are subject to the full set of [http://www.fda.gov/cdrh/devadvice/3133.html general controls], including that they be "manufactured under a [http://www.fda.gov/cdrh/devadvice/32.html quality assurance program], be suitable for the intended use, be adequately packaged and properly labeled, and have establishment registration and device listing forms on file with the FDA." [http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?start_search=1&DeviceName=&ProductCode=&ThirdParty=&DeviceClass=1&SUBMISSION_TYPE_ID=4&GMPExempt=Y&Panel=&RegulationNumber=890.3420&PAGENUM=10&SortColumn=DeviceName prosthetic components] and a [http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/315.cfm few other devices] are exempt from these general requirements and subject only to [http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?FR=820.180 record keeping (21CFR820.180)] and [http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?FR=820.198 complaint file (21CFR820.198)] requirements, as stated in the [http://en.wikipedia.org/wiki/Code_of_Federal_Regulations Code of Federal Regulations], Title 21, Chapter I, Subchapter H, Part 890, Subpart D, Physical Medicine Prosthetic Devices, Sec. 890.3420, External limb prosthetic component, or [http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=890.3420 21CFR890.3420]. This section states that these devices are exempt from premarket approval or [http://www.fda.gov/cdrh/devadvice/314.html 510(k)] requirements, except as provided in [http://www.accessdata.fda.gov/scrIpts/cdrh/cfdocs/search/search.cfm?db=CFR&ID=890.9 21CFR890.9], which allows this exemption as long as the new device has "existing or reasonably foreseeable characteristics of commercially distributed devices within that generic type," it is intended for the same use and the same user type as existing products, and the device operates on the same fundamental scientific technology. As [http://www.cigna.com/customer_care/healthcare_professional/coverage_positions/medical/mm_0233_coveragepositioncriteria_myoelectric_prostheses.pdf this document] from CIGNA (interesting for other reasons) points out, prostheses in their entirety are not mentioned, but all prosthetic device components are included.	+ In the United States, all upper and lower extremity prosthetic components are regulated as Class I (exempt) medical devices. The Federal Food and Drug Administration in the US (FDA), [http://www.fda.gov/cdrh/devadvice/3132.html classifies] medical devices as Class I, II or III. While most Class I devices are subject to the full set of [http://www.fda.gov/cdrh/devadvice/3133.html general controls], including that they be "manufactured under a [http://www.fda.gov/cdrh/devadvice/32.html quality assurance program], be suitable for the intended use, be adequately packaged and properly labeled, and have establishment registration and device listing forms on file with the FDA." [http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?start_search=1&DeviceName=&ProductCode=&ThirdParty=&DeviceClass=1&SUBMISSION_TYPE_ID=4&GMPExempt=Y&Panel=&RegulationNumber=890.3420&PAGENUM=10&SortColumn=DeviceName prosthetic components] and a [http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/315.cfm few other devices] are exempt from these general requirements and subject only to [http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?FR=820.180 record keeping (21CFR820.180)] and [http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?FR=820.198 complaint file (21CFR820.198)] requirements, as stated in the [http://en.wikipedia.org/wiki/Code_of_Federal_Regulations Code of Federal Regulations], Title 21, Chapter I, Subchapter H, Part 890, Subpart D, Physical Medicine Prosthetic Devices, Sec. 890.3420, External limb prosthetic component, or [http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=890.3420 21CFR890.3420]. This section states that these devices are exempt from premarket approval or [http://www.fda.gov/cdrh/devadvice/314.html 510(k)] requirements, except as provided in [http://www.accessdata.fda.gov/scrIpts/cdrh/cfdocs/search/search.cfm?db=CFR&ID=890.9 21CFR890.9], which allows this exemption as long as the new device has "existing or reasonably foreseeable characteristics of commercially distributed devices within that generic type," it is intended for the same use and the same user type as existing products, and the device operates on the same fundamental scientific technology. As [http://www.cigna.com/customer_care/healthcare_professional/coverage_positions/medical/mm_0233_coveragepositioncriteria_myoelectric_prostheses.pdf this document] from CIGNA (interesting for ["Reimbursement and Insurance Coverage of Prosthetics" other reasons]) points out, prostheses in their entirety are not mentioned, but all prosthetic device components are included.

Federal Regulation of Prostheses

JonKuniholm — 2008-01-09 18:26:45

Differences for Federal Regulation of Prostheses

Deletions are marked with - .	Additions are marked with +.
Line 3:	Line 3:
- There are no regulations regarding custom parts made by prosthetic technicians and included in a completed prosthesis, or to customization of parts after distribution by a registered manufacturer. While it could be construed from the language in the exemption from the general controls above (which subject prosthetic limb component manufacture only to parts 820.198 and 820.180, and do not mention facility registration, included in the general controls), it is reasonable to assume that facility registration is [http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?FR=807.65 required]. [http://www.oandp.com/products/trs/ TRS Inc.], or Therapeutic Recreation Systems Inc., run by amputee Bob Radocy in Colorado, for example, is [http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/Registration.cfm?ID=1849 registered] with owner/operator and registration number 1718966.	+ There are no regulations regarding custom parts made by prosthetic technicians and included in a completed prosthesis, or to customization of parts after distribution by a registered establishment. While it could be construed from the language in the exemption from the general controls above (which subject prosthetic limb component manufacture only to parts 820.198 and 820.180, and do not mention facility registration, included in the general controls), it is reasonable to assume that establishment registration is [http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?FR=807.65 required]. [http://www.oandp.com/products/trs/ TRS Inc.], or Therapeutic Recreation Systems Inc., run by amputee Bob Radocy in Colorado, for example, is [http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/Registration.cfm?ID=1849 registered] with owner/operator and registration number 1718966. Interestingly enough, the establishment registration requirement prohibits publishing or broadcasting the registration number in any way, presumably to avoid any suggestion that the establishment or the device has been approved by the FDA.

Federal Regulation of Prostheses

JonKuniholm — 2008-01-09 18:23:16

Differences for Federal Regulation of Prostheses

Deletions are marked with - .	Additions are marked with +.
Line 3:	Line 3:
- There are no regulations regarding custom parts made by prosthetic technicians and included in a completed prosthesis, or to customization of parts after distribution by a registered manufacturer. It is unclear whether [http://www.oandp.com/products/trs/ TRS Inc.], or Therapeutic Recreation Systems Inc., run by amputee Bob Radocy in Colorado, for example, is [http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/Registration.cfm?ID=1849 registered] with owner/operator and registration number 1718966.	+ There are no regulations regarding custom parts made by prosthetic technicians and included in a completed prosthesis, or to customization of parts after distribution by a registered manufacturer. While it could be construed from the language in the exemption from the general controls above (which subject prosthetic limb component manufacture only to parts 820.198 and 820.180, and do not mention facility registration, included in the general controls), it is reasonable to assume that facility registration is [http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?FR=807.65 required]. [http://www.oandp.com/products/trs/ TRS Inc.], or Therapeutic Recreation Systems Inc., run by amputee Bob Radocy in Colorado, for example, is [http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/Registration.cfm?ID=1849 registered] with owner/operator and registration number 1718966.

Federal Regulation of Prostheses

JonKuniholm — 2008-01-09 18:16:05

Differences for Federal Regulation of Prostheses

Deletions are marked with - .	Additions are marked with +.
Line 1:	Line 1:
- In the United States, all upper and lower extremity prosthetic components are regulated as Class I (exempt) medical devices. The Federal Food and Drug Administration in the US (FDA), [http://www.fda.gov/cdrh/devadvice/3132.html classifies] medical devices as Class I, II or III. While most Class I devices are subject to the full set of [http://www.fda.gov/cdrh/devadvice/3133.html general controls], including that they be "manufactured under a [http://www.fda.gov/cdrh/devadvice/32.html quality assurance program], be suitable for the intended use, be adequately packaged and properly labeled, and have establishment registration and device listing forms on file with the FDA." [http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?start_search=1&DeviceName=&ProductCode=&ThirdParty=&DeviceClass=1&SUBMISSION_TYPE_ID=4&GMPExempt=Y&Panel=&RegulationNumber=890.3420&PAGENUM=10&SortColumn=DeviceName prosthetic components] and a [http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/315.cfm few other devices] are exempt from these general requirements and subject only to [http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?FR=820.180 record keeping (21CFR820.180)] and [http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?FR=820.198 complaint file (21CFR820.198)] requirements.	+ In the United States, all upper and lower extremity prosthetic components are regulated as Class I (exempt) medical devices. The Federal Food and Drug Administration in the US (FDA), [http://www.fda.gov/cdrh/devadvice/3132.html classifies] medical devices as Class I, II or III. While most Class I devices are subject to the full set of [http://www.fda.gov/cdrh/devadvice/3133.html general controls], including that they be "manufactured under a [http://www.fda.gov/cdrh/devadvice/32.html quality assurance program], be suitable for the intended use, be adequately packaged and properly labeled, and have establishment registration and device listing forms on file with the FDA." [http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?start_search=1&DeviceName=&ProductCode=&ThirdParty=&DeviceClass=1&SUBMISSION_TYPE_ID=4&GMPExempt=Y&Panel=&RegulationNumber=890.3420&PAGENUM=10&SortColumn=DeviceName prosthetic components] and a [http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/315.cfm few other devices] are exempt from these general requirements and subject only to [http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?FR=820.180 record keeping (21CFR820.180)] and [http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?FR=820.198 complaint file (21CFR820.198)] requirements, as stated in the [http://en.wikipedia.org/wiki/Code_of_Federal_Regulations Code of Federal Regulations], Title 21, Chapter I, Subchapter H, Part 890, Subpart D, Physical Medicine Prosthetic Devices, Sec. 890.3420, External limb prosthetic component, or [http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=890.3420 21CFR890.3420]. This section states that these devices are exempt from premarket approval or [http://www.fda.gov/cdrh/devadvice/314.html 510(k)] requirements, except as provided in [http://www.accessdata.fda.gov/scrIpts/cdrh/cfdocs/search/search.cfm?db=CFR&ID=890.9 21CFR890.9], which allows this exemption as long as the new device has "existing or reasonably foreseeable characteristics of commercially distributed devices within that generic type," it is intended for the same use and the same user type as existing products, and the device operates on the same fundamental scientific technology. As [http://www.cigna.com/customer_care/healthcare_professional/coverage_positions/medical/mm_0233_coveragepositioncriteria_myoelectric_prostheses.pdf this document] from CIGNA (interesting for other reasons) points out, prostheses in their entirety are not mentioned, but all prosthetic device components are included.
Line 3:	Line 3:
- As [http://www.cigna.com/customer_care/healthcare_professional/coverage_positions/medical/mm_0233_coveragepositioncriteria_myoelectric_prostheses.pdf this document] from CIGNA (interesting for other reasons) points out, prostheses in their entirety are not mentioned, but all prosthetic device components are included in the [http://en.wikipedia.org/wiki/Code_of_Federal_Regulations Code of Federal Regulations], Title 21, Chapter I, Subchapter H, Part 890, Subpart D, Physical Medicine Prosthetic Devices, Sec. 890.3420, External limb prosthetic component, or [http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=890.3420 21CFR890.3420]. This section states that these devices are exempt from premarket approval or [http://www.fda.gov/cdrh/devadvice/314.html 510(k)] requirements, except as provided in [http://www.accessdata.fda.gov/scrIpts/cdrh/cfdocs/search/search.cfm?db=CFR&ID=890.9 21CFR890.9], which allows this exemption as long as the new device has "existing or reasonably foreseeable characteristics of commercially distributed devices within that generic type," it is intended for the same use and the same user type as existing products, and the device operates on the same fundamental scientific technology. - - - Additionally, there are no regulations regarding custom parts made by prosthetic technicians and included in a completed prosthesis, or to customization of parts made by a registered manufacturer. - - [http://www.oandp.com/products/trs/ TRS Inc.], or Therapeutic Recreation Systems Inc., run by amputee Bob Radocy in Colorado, for example, is [http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/Registration.cfm?ID=1849 registered] with owner/operator and registration number 1718966.	+ There are no regulations regarding custom parts made by prosthetic technicians and included in a completed prosthesis, or to customization of parts after distribution by a registered manufacturer. It is unclear whether [http://www.oandp.com/products/trs/ TRS Inc.], or Therapeutic Recreation Systems Inc., run by amputee Bob Radocy in Colorado, for example, is [http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/Registration.cfm?ID=1849 registered] with owner/operator and registration number 1718966.

Federal Regulation of Prostheses

JonKuniholm — 2008-01-09 18:09:55

Differences for Federal Regulation of Prostheses

Deletions are marked with - .	Additions are marked with +.
Line 1:	Line 1:
- In the United States, all upper and lower extremity prosthetic components are regulated as Class I (exempt) medical devices. The Federal Food and Drug Administration in the US (FDA), [http://www.fda.gov/cdrh/devadvice/3132.html classifies] medical devices as Class I, II or III. While most Class I devices are subject to the full set of [http://www.fda.gov/cdrh/devadvice/3133.html general controls], including that they be "manufactured under a [http://www.fda.gov/cdrh/devadvice/32.html quality assurance program], be suitable for the intended use, be adequately packaged and properly labeled, and have establishment registration and device listing forms on file with the FDA." [http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?start_search=1&DeviceName=&ProductCode=&ThirdParty=&DeviceClass=1&SUBMISSION_TYPE_ID=4&GMPExempt=Y&Panel=&RegulationNumber=890.3420&PAGENUM=10&SortColumn=DeviceName prosthetic components] and a [http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/315.cfm few other devices] are exempt from these general requirements and subject only to record keeping and complaint file [http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/315.cfm requirements].	+ In the United States, all upper and lower extremity prosthetic components are regulated as Class I (exempt) medical devices. The Federal Food and Drug Administration in the US (FDA), [http://www.fda.gov/cdrh/devadvice/3132.html classifies] medical devices as Class I, II or III. While most Class I devices are subject to the full set of [http://www.fda.gov/cdrh/devadvice/3133.html general controls], including that they be "manufactured under a [http://www.fda.gov/cdrh/devadvice/32.html quality assurance program], be suitable for the intended use, be adequately packaged and properly labeled, and have establishment registration and device listing forms on file with the FDA." [http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?start_search=1&DeviceName=&ProductCode=&ThirdParty=&DeviceClass=1&SUBMISSION_TYPE_ID=4&GMPExempt=Y&Panel=&RegulationNumber=890.3420&PAGENUM=10&SortColumn=DeviceName prosthetic components] and a [http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/315.cfm few other devices] are exempt from these general requirements and subject only to [http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?FR=820.180 record keeping (21CFR820.180)] and [http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?FR=820.198 complaint file (21CFR820.198)] requirements.

Federal Regulation of Prostheses

JonKuniholm — 2008-01-09 18:02:28

Differences for Federal Regulation of Prostheses

Deletions are marked with - .	Additions are marked with +.
Line 1:	Line 1:
- In the United States, all upper and lower extremity prosthetic components are regulated as Class I (exempt) medical devices. The Federal Food and Drug Administration in the US (FDA), [http://www.fda.gov/cdrh/devadvice/3132.html classifies] medical devices as Class I, II or III. While most Class I devices are subject to the full set of [http://www.fda.gov/cdrh/devadvice/3133.html general controls], including that they be "manufactured under a [http://www.fda.gov/cdrh/devadvice/32.html quality assurance program], be suitable for the intended use, be adequately packaged and properly labeled, and have establishment registration and device listing forms on file with the FDA." [http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/315.cfm?GMPPart=890#start prosthetic components and a few other devices] are exempt from these general requirements and subject only to record keeping and complaint file [http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/315.cfm requirements].	+ In the United States, all upper and lower extremity prosthetic components are regulated as Class I (exempt) medical devices. The Federal Food and Drug Administration in the US (FDA), [http://www.fda.gov/cdrh/devadvice/3132.html classifies] medical devices as Class I, II or III. While most Class I devices are subject to the full set of [http://www.fda.gov/cdrh/devadvice/3133.html general controls], including that they be "manufactured under a [http://www.fda.gov/cdrh/devadvice/32.html quality assurance program], be suitable for the intended use, be adequately packaged and properly labeled, and have establishment registration and device listing forms on file with the FDA." [http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?start_search=1&DeviceName=&ProductCode=&ThirdParty=&DeviceClass=1&SUBMISSION_TYPE_ID=4&GMPExempt=Y&Panel=&RegulationNumber=890.3420&PAGENUM=10&SortColumn=DeviceName prosthetic components] and a [http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/315.cfm few other devices] are exempt from these general requirements and subject only to record keeping and complaint file [http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/315.cfm requirements].

Federal Regulation of Prostheses

JonKuniholm — 2008-01-09 17:59:33

Differences for Federal Regulation of Prostheses

Deletions are marked with - .	Additions are marked with +.
Line 1:	Line 1:
- In the United States, all upper and lower extremity prosthetic components are regulated as Class I (exempt) medical devices. The Federal Food and Drug Administration in the US (FDA), [http://www.fda.gov/cdrh/devadvice/3132.html classifies] medical devices as Class I, II or III. While most Class I devices are subject to the full set of [http://www.fda.gov/cdrh/devadvice/3133.html general controls], including that they be "manufactured under a quality assurance program, be suitable for the intended use, be adequately packaged and properly labeled, and have establishment registration and device listing forms on file with the FDA." [http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/315.cfm?GMPPart=890#start prosthetic components and a few other devices] are subject only to record keeping and complaint file [http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/315.cfm requirements].	+ In the United States, all upper and lower extremity prosthetic components are regulated as Class I (exempt) medical devices. The Federal Food and Drug Administration in the US (FDA), [http://www.fda.gov/cdrh/devadvice/3132.html classifies] medical devices as Class I, II or III. While most Class I devices are subject to the full set of [http://www.fda.gov/cdrh/devadvice/3133.html general controls], including that they be "manufactured under a [http://www.fda.gov/cdrh/devadvice/32.html quality assurance program], be suitable for the intended use, be adequately packaged and properly labeled, and have establishment registration and device listing forms on file with the FDA." [http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/315.cfm?GMPPart=890#start prosthetic components and a few other devices] are exempt from these general requirements and subject only to record keeping and complaint file [http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/315.cfm requirements].
Line 3:	Line 3:
- although as [http://www.cigna.com/customer_care/healthcare_professional/coverage_positions/medical/mm_0233_coveragepositioncriteria_myoelectric_prostheses.pdf this document] from CIGNA (interesting for other reasons) points out, prostheses in their entirety are not regulated. All of these device components are included in the [http://en.wikipedia.org/wiki/Code_of_Federal_Regulations Code of Federal Regulations], Title 21, Chapter I, Subchapter H, Part 890, Subpart D, Physical Medicine Prosthetic Devices, Sec. 890.3420, External limb prosthetic component, or [http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=890.3420 21CFR890.3420]. This section states that these devices are exempt from premarket approval requirements.	+ As [http://www.cigna.com/customer_care/healthcare_professional/coverage_positions/medical/mm_0233_coveragepositioncriteria_myoelectric_prostheses.pdf this document] from CIGNA (interesting for other reasons) points out, prostheses in their entirety are not mentioned, but all prosthetic device components are included in the [http://en.wikipedia.org/wiki/Code_of_Federal_Regulations Code of Federal Regulations], Title 21, Chapter I, Subchapter H, Part 890, Subpart D, Physical Medicine Prosthetic Devices, Sec. 890.3420, External limb prosthetic component, or [http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=890.3420 21CFR890.3420]. This section states that these devices are exempt from premarket approval or [http://www.fda.gov/cdrh/devadvice/314.html 510(k)] requirements, except as provided in [http://www.accessdata.fda.gov/scrIpts/cdrh/cfdocs/search/search.cfm?db=CFR&ID=890.9 21CFR890.9], which allows this exemption as long as the new device has "existing or reasonably foreseeable characteristics of commercially distributed devices within that generic type," it is intended for the same use and the same user type as existing products, and the device operates on the same fundamental scientific technology. +

Federal Regulation of Prostheses

JonKuniholm — 2008-01-09 17:38:13

Differences for Federal Regulation of Prostheses

Deletions are marked with - .	Additions are marked with +.
Line 1:	Line 1:
- In the United States, all upper and lower prosthetic components are regulated as Class I (exempt) medical devices. The Federal Food and Drug Administration in the US (FDA), [http://www.fda.gov/cdrh/devadvice/3132.html classifies] medical devices as Class I, II or III. While most Class I devices are subject to the full set of [http://www.fda.gov/cdrh/devadvice/3133.html general controls], including that they be "manufactured under a quality assurance program, be suitable for the intended use, be adequately packaged and properly labeled, and have establishment registration and device listing forms on file with the FDA." [http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/315.cfm?GMPPart=890#start prosthetic components and a few other devices] are subject only to record keeping and complaint file [http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/315.cfm requirements].	+ In the United States, all upper and lower extremity prosthetic components are regulated as Class I (exempt) medical devices. The Federal Food and Drug Administration in the US (FDA), [http://www.fda.gov/cdrh/devadvice/3132.html classifies] medical devices as Class I, II or III. While most Class I devices are subject to the full set of [http://www.fda.gov/cdrh/devadvice/3133.html general controls], including that they be "manufactured under a quality assurance program, be suitable for the intended use, be adequately packaged and properly labeled, and have establishment registration and device listing forms on file with the FDA." [http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/315.cfm?GMPPart=890#start prosthetic components and a few other devices] are subject only to record keeping and complaint file [http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/315.cfm requirements].

Federal Regulation of Prostheses

JonKuniholm — 2008-01-09 17:37:56

Differences for Federal Regulation of Prostheses

Deletions are marked with - .	Additions are marked with +.
Line 1:	Line 1:
- In the United States, all upper and lower prosthetic components are regulated as Class I (exempt) medical devices. The Federal Food and Drug Administration in the US (FDA), [http://www.fda.gov/cdrh/devadvice/3132.html classifies] medical devices as Class I, II or III. While most Class I devices are subject to the full set of general controls, [http://www.fda.gov/cdrh/devadvice/3133.html prosthetic components and a few other devices] are subject only to record keeping and complaint file [http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/315.cfm requirements].	+ In the United States, all upper and lower prosthetic components are regulated as Class I (exempt) medical devices. The Federal Food and Drug Administration in the US (FDA), [http://www.fda.gov/cdrh/devadvice/3132.html classifies] medical devices as Class I, II or III. While most Class I devices are subject to the full set of [http://www.fda.gov/cdrh/devadvice/3133.html general controls], including that they be "manufactured under a quality assurance program, be suitable for the intended use, be adequately packaged and properly labeled, and have establishment registration and device listing forms on file with the FDA." [http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/315.cfm?GMPPart=890#start prosthetic components and a few other devices] are subject only to record keeping and complaint file [http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/315.cfm requirements].

Federal Regulation of Prostheses

JonKuniholm — 2008-01-09 17:34:17

Differences for Federal Regulation of Prostheses

Deletions are marked with - .	Additions are marked with +.
Line 1:	Line 1:
- In the United States, all upper and lower prosthetic components are regulated as Class I (exempt) medical devices. The Federal Food and Drug Administration in the US (FDA), [http://www.fda.gov/cdrh/devadvice/3132.html classifies] medical devices as Class I, II or III. While most Class I devices are subject to the full set of general controls, [http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/315.cfm prosthetic components and a few other devices] are subject only to record keeping and complaint file [http://www.fda.gov/cdrh/devadvice/3133.html requirements].	+ In the United States, all upper and lower prosthetic components are regulated as Class I (exempt) medical devices. The Federal Food and Drug Administration in the US (FDA), [http://www.fda.gov/cdrh/devadvice/3132.html classifies] medical devices as Class I, II or III. While most Class I devices are subject to the full set of general controls, [http://www.fda.gov/cdrh/devadvice/3133.html prosthetic components and a few other devices] are subject only to record keeping and complaint file [http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/315.cfm requirements].

Federal Regulation of Prostheses

JonKuniholm — 2008-01-09 17:33:41

Differences for Federal Regulation of Prostheses

Deletions are marked with - .	Additions are marked with +.
Line 1:	Line 1:
	+ In the United States, all upper and lower prosthetic components are regulated as Class I (exempt) medical devices. The Federal Food and Drug Administration in the US (FDA), [http://www.fda.gov/cdrh/devadvice/3132.html classifies] medical devices as Class I, II or III. While most Class I devices are subject to the full set of general controls, [http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/315.cfm prosthetic components and a few other devices] are subject only to record keeping and complaint file [http://www.fda.gov/cdrh/devadvice/3133.html requirements]. + + although as [http://www.cigna.com/customer_care/healthcare_professional/coverage_positions/medical/mm_0233_coveragepositioncriteria_myoelectric_prostheses.pdf this document] from CIGNA (interesting for other reasons) points out, prostheses in their entirety are not regulated. All of these device components are included in the [http://en.wikipedia.org/wiki/Code_of_Federal_Regulations Code of Federal Regulations], Title 21, Chapter I, Subchapter H, Part 890, Subpart D, Physical Medicine Prosthetic Devices, Sec. 890.3420, External limb prosthetic component, or [http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=890.3420 21CFR890.3420]. This section states that these devices are exempt from premarket approval requirements. + + Additionally, there are no regulations regarding custom parts made by prosthetic technicians and included in a completed prosthesis, or to customization of parts made by a registered manufacturer. + + [http://www.oandp.com/products/trs/ TRS Inc.], or Therapeutic Recreation Systems Inc., run by amputee Bob Radocy in Colorado, for example, is [http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/Registration.cfm?ID=1849 registered] with owner/operator and registration number 1718966.