New Guidance Document on IDE/INDA Submissions for Knee Cartilage Replacement Products Released
The US Food and Drug Administration (FDA) today announced a new guidance document titled, Guidance for Industry: Preparation of IDEs and INDs for Products Intended to Repair or Replace Knee Cartilage. The document provides recommendations for sponsors of an Investigational Device Examption (IDE) or Investigational New Drug (IND) application about what should be included in submission documents for a product intended to "repair or replace knee cartilage."
The guidance covers biologics, devices or combination products intended to repair or replace knee cartilage under the regulatory oversight of the Center for Biologics Evaluation and Research (CBER) and/or the Center of Devices and Radiological Health (CDRH). This guidance does not apply to prostheses, total knee implants, meniscus replacement products or human cells, tissues and cellular and tissue-based products (HCT/Ps).
The guidance is the final form of a draft issued in July of 2007, and addresses issues that might come up during the development of the covered products. In response to comments received on the draft guidance, FDA added several sections, including clinical study schedules and nonclinical data considerations. In addition, some terminology was changed to make the guidance document's language consistent with other terminology used within the agency.
Comments may be submitted to the agency at any time.