FDA Regulations for the Use of Neoform

NeoForm consists of human dermal tissue that has been sterilized and preserved using a specific cleaning process, according to the Mentor website. It acts as a bridge or support for normal tissue growth, and with healing the implant will become a healthy part of the body. The FDA has requirements regarding facilities, storage, distribution, equipment and labeling to help prevent the spread of disease or contamination through tissue implants such as NeoForm.

Facilities

• The Food and Drug Administration has regulated this field closely since 1993 to ensure the safety of human tissue implants, according to the Mentor website. The FDA chose to regulate tissues under the legal authority of Section 361 (Sec. 361) of the Public Health Service Act. The FDA regulates NeoForm and other similar products solely as "361 products" when they meet all of the specific criteria. Tissues are also regulated by the Center for Biologics Evaluation and Research. Facilities and establishments are required by the FDA to register with the Center for Biologics Evaluation and Research and list their human cells, tissues, and cellular and tissue-based products. Storage facilities must register within five days of beginning operations. Facilities must be of suitable size, location and construction and have proper draining, plumbing and ventilation to prevent the spread of disease.

Sanitation and Storage Requirements

• Equipment used in the processing of human tissue must be cleaned, sanitized and maintained according to established schedules, as required by the FDA. Records must be kept of maintenance. The FDA also requires that human cells or tissue from two or more donors must not be placed in physical contact or mixed in a single receptacle. Tissues must be labeled in an accurate, legible manner. Storage areas must be set up in a way to prevent the spread of disease. These requirements include storing samples at an appropriate temperature, assigning expiration dates and keeping records. Corrective action must be taken immediately if any procedure is not followed.

Donors

• Each NeoForm implant can be traced back to the original donor. Donors selected are negative for HIV-1, HIV-2, hepatitis B and C, HTLV-1, HTLV-2 and syphilis. In addition, the donor selection process includes medical record screening and next-of-kin interviews. The FDA also has its own list of requirements for donor eligibility. Donors must be screened for risk of or evidence of communicable disease agents and diseases and communicable disease risks associated with xenotransplantation.