FDA Extends Enforcement Discretion Policy for Certain Regenerative Medicine Products

B2B Training: What’s the Most Effective Way of Learning?

B2B training, which is short for business-to-business training, is a popular and convenient type of training that enables entire companies to train their teams...

AlixPartners Forecasts: Household Products Could Cost U.S. Manufacturers and Consumers 15% More This Year Due to Resin Shortage

While companies can’t control the market forces at play, they can take action to mitigate the risk and impact of supply chain disruption.

Regenerative Medicine Products: Today, the U.S. Food and Drug Administration is extending the enforcement discretion policy for certain human cell, tissue, and cellular and tissue-based products (HCT/Ps).

As a result of the challenges presented by the COVID-19 public health emergency, the FDA is extending its enforcement discretion policy which will provide manufacturers and potential sponsors an additional six months to determine if 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 FDA’s November 2017 regenerative medicine policy framework was developed to help facilitate and support the innovation of regenerative medicine therapies. The agency also outlined its intent to exercise enforcement discretion, until November 2020, for certain regenerative medicine products, with respect to the FDA’s IND and premarket approval requirements; to give manufacturers time to determine what requirements apply as well as engage with the agency. The FDA is revising the guidance to reflect that FDA generally intends to exercise enforcement discretion with respect to IND and premarket approval requirements for certain HCT/Ps through May 2021.

“To be clear, our policy of enforcement discretion only pertains to certain human cell, tissue and cellular and tissue-based products that do not raise potential significant safety concerns or reported safety concerns. This policy was never intended to provide a cover for bad actors, and we intend to continue to take action against manufacturers and health care providers who are offering unapproved regenerative medicine products that have the potential to put patients at significant risk,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research (CBER).

Since the issuance of the comprehensive regenerative medicine policy framework in late 2017, the FDA has worked with product developers to determine if they need marketing authorization application and, if so, how they should submit their application to the FDA.

Importantly, the agency’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. The agency has stepped up its oversight of cellular and related products in recent years and has issued compliance actions, including numerous warning and untitled letters, and pursued litigation for serious violations of the law, including some involving patient harm.

Patients should make sure that any regenerative medicine product they are considering is either FDA-approved or being studied under an IND, which is a clinical investigation plan submitted and allowed to proceed by the FDA.

Additional Resources:

spot_img

DON'T MISS

Mediclinic Appoints 2 New Independent Non-Executive Directors

Natalia Barsegiyan and Zarina Bassa will bring significant and diverse skills and experience, complementing those of existing Board members. I am confident they will both be great additions to our Board of Directors.”

Asensus Surgical Appoints Two New Board Members

Asensus Surgical, Inc. (NYSE American: ASXC), a medical device company that is digitizing the interface between the surgeon and the patient to pioneer a new era of Performance-Guided Surgery™, today announced the expansion of its Board of Directors, appointing...

Our Sister Publication: Biotechnology News Magazine

Subscribe to Medical Device News Magazine here.