FDA Extends Enforcement Discretion Policy for Certain Regenerative Medicine Products

August 4, 2020

The discretion period end point has been extended from November 2020 to May 2021

The U.S. Food and Drug Administration (FDA) extended its enforcement discretion policy for certain human cell, tissue, and cellular and tissue-based products (HCT/Ps) from November 2020 to May 2021.

The discretionary period was put into place after the regenerative medicine policy framework was established. The discretionary period was originally intended to aid manufacturers in approaching and engaging with the agency to determine what requirements applied to their products and how exactly these products should be classified. Due to challenges prevalent with the onset of COVID-19, FDA has officially announced that they will be extending this discretionary period from November 2020 to May 2021.

The key takeaways from FDA's press release are detailed below:

  • FDA is extending its enforcement discretion policy, which will provide manufacturers and potential sponsors an additional six months to determine whether they need to submit an Investigational New Drug (IND) or marketing application and, if such an application is needed, to prepare and submit the application, as appropriate.
  • The discretionary period was never intended to provide a cover for manufacturers or health care providers offering unapproved regenerative medicine products that could put patients at significant risk, and as such, FDA intends to continue taking enforcement action.
  • FDA's enforcement discretion policy for IND and premarket approval requirements does not apply to products that have been associated with reported safety concerns or have the potential to cause significant safety concerns to patients.
  • FDA has been committed to assisting product developers with guidance on whether they need marketing authorization since the inception of the comprehensive regenerative medicine policy framework in 2017. If an application is needed, they are also providing guidance on how those should be submitted and what specific regulatory pathways need to be considered.

How Exponent Can Help

Exponent's multidisciplinary team of biomedical engineers, health scientists, and regulatory consultants can help manufacturers and health care providers of regenerative medicine products understand the nuances of FDA's new regulatory framework and efficiently guide their products through the next phase of regulation. Exponent can also support mechanical, chemical, and human factors testing that may be required for standard regulatory submissions.