FDA classification

[Guest guest]

I know that this is not the place where this is usually discussed,

but I thought some members would be interested in bringing this to

the attention of their orthotists.

http://www.oandp.org/cranialhelmet.htm

It is an attempt to change the classification system so that local

orthotists who have been making helmets for the last twenty years or

so may continue to legally do so.

(For the record, I am an orthotist, but am not affected directly, as

I work in Australia)

[Guest guest]

>I know that this is not the place where this is usually discussed, >but I thought some members would be interested in bringing this to >the attention of their orthotists. >http://www.oandp.org/cranialhelmet.htm >It is an attempt to change the classification system so that local >orthotists who have been making helmets for the last twenty years or >so may continue to legally do so. >(For the record, I am an orthotist, but am not affected directly, as >I work in Australia)

Ron and all,

I read your post from my digest last night and linked to the petition you are referring to, which I have copied and included below. I am not trying to start an argument, just sharing my thoughts on this, for what it is worth.

How old is this petition? The bottom line I cut and pasted so all could see is 1998. The petition closes April 30 of what year? The reason I wonder is that since this petition mentions ONLY Cranial Technologies and the DOC band. Orthomerica's STAR Band and the Gillette Craniocap are also FDA APPROVED. The STAR Band is available to EVERY ORTHOTIST WITH A LICENSE IN THE US, so the argument that "large segments of the population, such as the infant on state welfare or the low-income infant (markets not traditionally serviced by Cranial Technologies) would be without care" is no longer valid.

Here is 's summary of this and the links to the FDA approval documents (for your reference) - from his post in the Plagiocephaly archives - Post # 10392

As strange as this may sound, that is pretty much all Orthomerica (STAR Band, was OPI Band) and Gillette Children's (Craniocap) had to do to get FDA approval. For example, on bottom of page 2 for the Craniocap pdf file http://www.fda.gov/cdrh/pdf/k000861.pdf and page 4 of the Orthomerica pdf file http://www.fda.gov/cdrh/pdf/k001167.pdf, the FDA approval letter states "The FDA finding of substantial equivalence for your device to the legally marketed predicate device results in a classification of your device and thus, permits your device to proceed to market." The predicate device is the DOC band (see below). That means that Orthomerica and Gillette Children's could simply cite research conducted by Cranial Technologies. Take a look for yourself: Cranial Tech Summary/Approval http://www.fda.gov/cdrh/pdf/k964992.pdf Orthomerica (STAR Band, was OPI Band) http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=915 Note "Decision: SUBSTANTIALLY EQUIVALENT" Summary/Approval http://www.fda.gov/cdrh/pdf/k001167.pdf Note page 1 section B, the "Predicate Device is the Doc Band" Gillette Children's (Craniocap) http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=676 Note "Decision: SUBSTANTIALLY EQUIVALENT" Summary/Approval http://www.fda.gov/cdrh/pdf/k000861.pdf Note page 1, the "Predicate Device is the Doc Band" The "intend uses" for Orthomerica (STAR Band, was OPI Band) and Gillette Children's (Craniocap) are taken almost verbatim from the DOC band. And believe it or not, the research described in the Orthomerica document, is research conducted by Cranial Technologies. The "Researchers studying the effects of treatment... with 12, 18 and 24 month follow-ups..." (page 2 of http://www.fda.gov/cdrh/pdf/k001167.pdf) are Littlefield, and others (articles available at http://www.plagiocephaly.org/resources/default.htm and http://www.cranialtech.com/infocenter/infocent.htm). LET ME BE VERY CLEAR ON THIS, I'm not saying there's anything wrong with predicate approval of these devices. However, let's give credit where credit is due. These devices are available because of Cranial Tech's investment in a system of monitoring and quality assurance.

It is my opinion that financial hardship is not a valid reason to remove FDA regulations from cranial molding devices! It is my understanding that Cranial Technologies had also been successfully treating plagiocephaly for a decade before the FDA made the ruling which made them jump through the same hoops the cranial molding helmets have to by the class 2 ruling. And I'm sure that it was a financial hardship to Cranial Technologies as well, especially since they ONLY do cranial banding and have no other O & P practice to fall back on. Cranial Technologies proved that DOC banding worked, and Orthomerica and Gillette had to simply show equivalency to the DOC band, and were not required to provide research on their product - just cite CT's. And they are still required to provide the quality control the FDA requests and the rest of the stuff Class 2 requires, as they should. We are talking about reshaping our children's craniums here for a lifetime, not to mention the short period of time there is to get it right! Our children DESERVE quality control!

The argument of "a financial hardship that would force many to abandon this segment of their practices. Thus, large segments of the population, such as the infant on state welfare or the low-income infant (markets not traditionally serviced by Cranial Technologies) would be without care" is scary, to me. . It seems good on the surface. Regulations should not be reclassifed to a lower regulatory standard for lower incomes and welfare - as this argument implies. Low-income and welfare populations should be receiving the SAME standard of care. The FDA's job is to ensure the safety of ALL citizens (including infants!) of the US, REGARDLESS of income with medical devices! To ask the FDA to legally allow lower standards because of financial hardship of the PROVIDER is acceptable? I hope not!!

I AM NOT SAYING CRANIAL MOLDING HELMETS DO NOT WORK! THERE ARE MANY, MANY EXCELLENT PROGRAMS OUT THERE! MY POINT IS THAT THEY SHOULD BE HELD TO THE SAME STANDARDS AS THE REST OF THE PROVIDERS, REGARDLESS OF COST OR INCONVENIENCE!

My apologies for the length of this post....I have NEVER been known for being concise! I did not intend to offend anyone!!!

Tami

CALL TO MEMBERSHIP FOR INFORMATION & ACTION

ISSUE: Cranial Molding Helmets

BACKGROUND: As you may know, the Food and Drug Administration has classified the D.O.C. Band (manufactured by Cranial Technologies, Phoenix, AZ) as a Class II medical device. Additionally, the regulation applies this control to all "cranial orthoses" used in the treatment of infants 3 to 18 months of age with non-synostotic positional plagiocephaly. The implication is that orthotists who currently design, fit, and fabricate these orthoses in their practices must either do so under violation of federal law, stop providing the orthoses, or complete the 510(k) process to become registered with the FDA to provide these orthoses.

PROBLEM: Filing a 510(k) application - a lengthy and expensive process - would require the tracking of certain processes and the application of control mechanisms that an orthotist, not being involved in traditional manufacturing processes, would be unable to provide without substantially changing his or her business. This would cause a financial hardship that would force many to abandon this segment of their practices. Thus, large segments of the population, such as the infant on state welfare or the low-income infant (markets not traditionally serviced by Cranial Technologies) would be without care.

POSITION: It is the Academy's view that orthotists have been safely and effectively designing, custom fabricating and fitting cranial molding helmets to their prescribing physician's specifications for nearly 20 years. These helmets are substantially equivalent to the devices described by Clarren in 1979 and first provided in the mid-1970's. These "Clarren style" helmets differ from the patented D.O.C.Bands by virtue of their passive design. Devices in commercial distribution prior to 1976 are exempt from regulation. Given the very close timing of the introduction of the first helmet by Dr. Clarren to the May 28, 1976 exemption date, and given that the "Clarren helmet" and the current delivery system have a historically safe record, the Academy believes the helmets provided by our profession should be deemed exempt.

PLAN: To file a petition with the FDA requesting that it consider this position.

YOUR HELP NEEDED: We need letters to attach to this petition.

From orthotists:We need letters endorsing this position and indicating the approximate the number of helmets fit and mentioning when you first began providing helmets.

From your referral sources:We need letters endorsing this position, indicating when they began prescribing helmets and emphasizing that they consider the helmets provided to have been safe and effective.

[Guest guest]

Thank you Tami!

Kendra in CanadaFor more plagio info, visitwww.plagiocephaly.org/support...

----- Original Message -----

From: Tami Warner

Plagiocephaly

Sent: Friday, March 30, 2001 8:37 AM

Subject: Re: FDA classification

Thank >I know that this is not the place where this is usually discussed, >but I thought some members would be interested in bringing this to >the attention of their orthotists. >http://www.oandp.org/cranialhelmet.htm >It is an attempt to change the classification system so that local >orthotists who have been making helmets for the last twenty years or >so may continue to legally do so. >(For the record, I am an orthotist, but am not affected directly, as >I work in Australia)

Ron and all,

I read your post from my digest last night and linked to the petition you are referring to, which I have copied and included below. I am not trying to start an argument, just sharing my thoughts on this, for what it is worth.

How old is this petition? The bottom line I cut and pasted so all could see is 1998. The petition closes April 30 of what year? The reason I wonder is that since this petition mentions ONLY Cranial Technologies and the DOC band. Orthomerica's STAR Band and the Gillette Craniocap are also FDA APPROVED. The STAR Band is available to EVERY ORTHOTIST WITH A LICENSE IN THE US, so the argument that "large segments of the population, such as the infant on state welfare or the low-income infant (markets not traditionally serviced by Cranial Technologies) would be without care" is no longer valid.

Here is 's summary of this and the links to the FDA approval documents (for your reference) - from his post in the Plagiocephaly archives - Post # 10392

As strange as this may sound, that is pretty much all Orthomerica (STAR Band, was OPI Band) and Gillette Children's (Craniocap) had to do to get FDA approval. For example, on bottom of page 2 for the Craniocap pdf file http://www.fda.gov/cdrh/pdf/k000861.pdf and page 4 of the Orthomerica pdf file http://www.fda.gov/cdrh/pdf/k001167.pdf, the FDA approval letter states "The FDA finding of substantial equivalence for your device to the legally marketed predicate device results in a classification of your device and thus, permits your device to proceed to market." The predicate device is the DOC band (see below). That means that Orthomerica and Gillette Children's could simply cite research conducted by Cranial Technologies. Take a look for yourself: Cranial Tech Summary/Approval http://www.fda.gov/cdrh/pdf/k964992.pdf Orthomerica (STAR Band, was OPI Band) http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=915 Note "Decision: SUBSTANTIALLY EQUIVALENT" Summary/Approval http://www.fda.gov/cdrh/pdf/k001167.pdf Note page 1 section B, the "Predicate Device is the Doc Band" Gillette Children's (Craniocap) http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=676 Note "Decision: SUBSTANTIALLY EQUIVALENT" Summary/Approval http://www.fda.gov/cdrh/pdf/k000861.pdf Note page 1, the "Predicate Device is the Doc Band" The "intend uses" for Orthomerica (STAR Band, was OPI Band) and Gillette Children's (Craniocap) are taken almost verbatim from the DOC band. And believe it or not, the research described in the Orthomerica document, is research conducted by Cranial Technologies. The "Researchers studying the effects of treatment... with 12, 18 and 24 month follow-ups..." (page 2 of http://www.fda.gov/cdrh/pdf/k001167.pdf) are Littlefield, and others (articles available at http://www.plagiocephaly.org/resources/default.htm and http://www.cranialtech.com/infocenter/infocent.htm). LET ME BE VERY CLEAR ON THIS, I'm not saying there's anything wrong with predicate approval of these devices. However, let's give credit where credit is due. These devices are available because of Cranial Tech's investment in a system of monitoring and quality assurance.

It is my opinion that financial hardship is not a valid reason to remove FDA regulations from cranial molding devices! It is my understanding that Cranial Technologies had also been successfully treating plagiocephaly for a decade before the FDA made the ruling which made them jump through the same hoops the cranial molding helmets have to by the class 2 ruling. And I'm sure that it was a financial hardship to Cranial Technologies as well, especially since they ONLY do cranial banding and have no other O & P practice to fall back on. Cranial Technologies proved that DOC banding worked, and Orthomerica and Gillette had to simply show equivalency to the DOC band, and were not required to provide research on their product - just cite CT's. And they are still required to provide the quality control the FDA requests and the rest of the stuff Class 2 requires, as they should. We are talking about reshaping our children's craniums here for a lifetime, not to mention the short period of time there is to get it right! Our children DESERVE quality control!

The argument of "a financial hardship that would force many to abandon this segment of their practices. Thus, large segments of the population, such as the infant on state welfare or the low-income infant (markets not traditionally serviced by Cranial Technologies) would be without care" is scary, to me. . It seems good on the surface. Regulations should not be reclassifed to a lower regulatory standard for lower incomes and welfare - as this argument implies. Low-income and welfare populations should be receiving the SAME standard of care. The FDA's job is to ensure the safety of ALL citizens (including infants!) of the US, REGARDLESS of income with medical devices! To ask the FDA to legally allow lower standards because of financial hardship of the PROVIDER is acceptable? I hope not!!

I AM NOT SAYING CRANIAL MOLDING HELMETS DO NOT WORK! THERE ARE MANY, MANY EXCELLENT PROGRAMS OUT THERE! MY POINT IS THAT THEY SHOULD BE HELD TO THE SAME STANDARDS AS THE REST OF THE PROVIDERS, REGARDLESS OF COST OR INCONVENIENCE!

My apologies for the length of this post....I have NEVER been known for being concise! I did not intend to offend anyone!!!

Tami

CALL TO MEMBERSHIP FOR INFORMATION & ACTION

ISSUE: Cranial Molding Helmets

BACKGROUND: As you may know, the Food and Drug Administration has classified the D.O.C. Band (manufactured by Cranial Technologies, Phoenix, AZ) as a Class II medical device. Additionally, the regulation applies this control to all "cranial orthoses" used in the treatment of infants 3 to 18 months of age with non-synostotic positional plagiocephaly. The implication is that orthotists who currently design, fit, and fabricate these orthoses in their practices must either do so under violation of federal law, stop providing the orthoses, or complete the 510(k) process to become registered with the FDA to provide these orthoses.

PROBLEM: Filing a 510(k) application - a lengthy and expensive process - would require the tracking of certain processes and the application of control mechanisms that an orthotist, not being involved in traditional manufacturing processes, would be unable to provide without substantially changing his or her business. This would cause a financial hardship that would force many to abandon this segment of their practices. Thus, large segments of the population, such as the infant on state welfare or the low-income infant (markets not traditionally serviced by Cranial Technologies) would be without care.

POSITION: It is the Academy's view that orthotists have been safely and effectively designing, custom fabricating and fitting cranial molding helmets to their prescribing physician's specifications for nearly 20 years. These helmets are substantially equivalent to the devices described by Clarren in 1979 and first provided in the mid-1970's. These "Clarren style" helmets differ from the patented D.O.C.Bands by virtue of their passive design. Devices in commercial distribution prior to 1976 are exempt from regulation. Given the very close timing of the introduction of the first helmet by Dr. Clarren to the May 28, 1976 exemption date, and given that the "Clarren helmet" and the current delivery system have a historically safe record, the Academy believes the helmets provided by our profession should be deemed exempt.

PLAN: To file a petition with the FDA requesting that it consider this position.

YOUR HELP NEEDED: We need letters to attach to this petition.

From orthotists:We need letters endorsing this position and indicating the approximate the number of helmets fit and mentioning when you first began providing helmets.

From your referral sources:We need letters endorsing this position, indicating when they began prescribing helmets and emphasizing that they consider the helmets provided to have been safe and effective.