FDA Certification for O&P
Dianne Farabi
Description
Collection
Title:
FDA Certification for O&P
Creator:
Dianne Farabi
Date:
11/19/2007
Text:
An inquiry has come to me regarding the need for an O&P facility (not a
manufacturer of O&P) to be certified by the FDA. The practitioner asking the
question says that he continued to certify annually with the FDA when he
took over the business because the company had always done so. Not
believing it was necessary to continue, he was visited by a representative
of the FDA the year he didn't send in the certification card. The
representative examined the business and told him it wasn't really in the
realm of the FDA but he should continue to send in the card every year since
he was on the books. Sending in the annual card to certify has not been a
problem until this year.
The problem is that now the FDA system is requiring a $1,700 to certify.
Has anyone else experienced this and does anyone know how to get
uncertified by the FDA?
The facility is in Ohio but this situation may have occurred in other
states.
Thanks for any input.
Dianne Farabi; Ohio O & P Association; Dublin, Ohio
manufacturer of O&P) to be certified by the FDA. The practitioner asking the
question says that he continued to certify annually with the FDA when he
took over the business because the company had always done so. Not
believing it was necessary to continue, he was visited by a representative
of the FDA the year he didn't send in the certification card. The
representative examined the business and told him it wasn't really in the
realm of the FDA but he should continue to send in the card every year since
he was on the books. Sending in the annual card to certify has not been a
problem until this year.
The problem is that now the FDA system is requiring a $1,700 to certify.
Has anyone else experienced this and does anyone know how to get
uncertified by the FDA?
The facility is in Ohio but this situation may have occurred in other
states.
Thanks for any input.
Dianne Farabi; Ohio O & P Association; Dublin, Ohio
Citation
Dianne Farabi, “FDA Certification for O&P,” Digital Resource Foundation for Orthotics and Prosthetics, accessed November 24, 2024, https://library.drfop.org/items/show/228731.
