EPICEL is FDA Approved
The Only FDA Approved CEA
EPICEL is a skin graft product that is approved by the FDA for use as a humanitarian use device (HUD).
An HUD is a device that is intended to benefit patients by treating or diagnosing a disease or condition that affects or is manifested in fewer than 4,000 individuals in the United States per year. The effectiveness of EPICEL has not been proven in clinical studies.
FDA approval underscores the strong safety and quality profile Epicel has maintained for over 20 years, providing yet another reason to feel confident choosing EPICEL to treat your patients.
Regulatory History and Details
Between the years 1988 and 1997, EPICEL was used to treat patients as an “unregulated device,” and was not subject to specific regulations.
In 1998, the FDA designated EPICEL as a combination product regulated as a medical device. The Center for Devices and Radiological Health (CDRH) became the primary agency for regulation and review of the product. The regulation of EPICEL by the CDRH was consistent with that of other skin-based dermal coverings.
On November 30, 1998, EPICEL was granted humanitarian use device (HUD) designation by the FDA. An HUD is a device that is intended to benefit patients by treating or diagnosing a disease or condition that affects or is manifested in fewer than 4,000 individuals in the United States per year. Per section 520(m) of the Federal Food, Drug, and Cosmetic Act (the Act), such devices are exempt from the effectiveness requirements outlined in sections 514 and 515 of the Act. The section of the Code of Federal Regulations (CFR) specific to HUDs (21 CFR § 814, Subpart H) implements section 520(m) of the Act.
Following HUD designation, Genzyme submitted theEPICEL humanitarian device exemption (HDE) application to the FDA on February 5, 1999. An HDE application is a premarket approval application (PMA) that is not required to contain clinical data demonstrating “effectiveness,” but contains all other standard PMA information and may contain special information to satisfy the statutory requirements established by section 520(m) of the Act.
In 2007, the FDA approved the HDE application making EPICEL the first FDA-approved CEA product on the market in the United States. In accordance with HUD regulations, the effectiveness of this device has not been demonstrated.
What EPICEL is not
EPICEL is not a 510(k) / PMA Medical Device. Epicel has been designated as a humanitarian use device (HUD) by the FDA. HUDs adhere to a different regulatory approval process than traditional medical devices, which follow either the 510(k) process or PMA process for approval.
According to FDA regulations, EPICEL, as an HDE-approved HUD product, must obtain IRB approval prior to use. EPICEL is not an “Investigational Product” or “Clinical Trial Material.” It is a common misconception, given the need for IRB approval, that Epicel is an experimental study material and therefore must be managed through the FDA IRB regulations concerning clinical trial material. This is not the case and therefore no clinical protocol, investigator brochure, or other such documents are necessary in order to treat with EPICEL; however, IRB approval is required by FDA for this type of HDE product to be used in the hospital.
EPICEL is not a “Compassionate Use” product. “Compassionate use” is a term used to describe the use of an experimental drug or device, or use of an approved drug or device for an unapproved use, in a seriously ill patient for whom no other treatment is available. Provided EPICEL is used within the scope of the indications for use, it is not considered compassionate use. Even in emergent use situations, where the physician determines that IRB approval cannot be obtained in time to prevent serious harm or death to the patient, EPICEL is not considered compassionate use if treated within the scope of the Indications For Use (label).