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*Tridynamic Home arrow *FDA Adapted Tricycles
FDA /Adapted Tricycles
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Dear Mr. Turner,

Thank you for the phone call yesterday. Our understanding from the call is that you believe that the manner in which FDA regulates the rehabilitation tricycles should be changed. As we discussed, the means by which you can bring this matter to the official attention of the Agency is through a Citizen Petition. A Petition of this type is described in the Code of Federal Regulations, Title 21, Section 10.30. This regulation can be found on the FDAs Web site by going to this link:

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm

and entering the search term 10.30 in the top search box. More information on the format and process associated with a Citizen Petition can be found in Section 10.20, which can be located on our Web site in the same manner. Although we cannot collaborate with you in putting together your petition, we can review and comment on a draft petition, should you wish.

We noted also that you reported that you and others of your acquaintance have experienced adverse events associated with the rehabilitation tricycles. As I mentioned, the Agency cannot look into these allegations without having a formal basis on which to do so. One effective way to report problems with medical products to the Agency is via a voluntary MedWatch report. Instructions on how to file this report can be found on FDAs Web site at this location:

https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm

Please note that the reporters confidentiality is generally protected from public disclosure. It would be helpful if you would be willing to encourage anyone who has had an adverse experience with a product regulated by FDA to use this report to let us know about it.

Thanks again. Please let us know if there are further questions or comments.

Regards,

David S. Buckles, PhD, FACC CDRH Ombudsman FDA/CDRH 10903 New Hampshire Ave., WO66-G414 Silver Spring, MD 20993 301-796-5447 (f) 301-847-8516



 
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