FDA Extends Enforcement Discretion Policy for Certain Regenerative Medicine Products

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:

Hot this week

Cartessa Aesthetics Partners with Classys to Bring EVERESSE to the U.S. Market

Classys, which is listed on the KOSDAQ, is one of South Korea's most distinguished aesthetic technology manufacturers, with devices distributed in 80+ markets globally. This partnership marks Classys's official entry into the American marketplace, with Cartessa Aesthetics as the exclusive distributor for EVERESSE, launched under the Volnewmer brand in current global markets.

Stryker Launches Next-Generation of SurgiCount+

Now integrated with Stryker's Triton technology, SurgiCount+ addresses two key challenges: retained surgical sponges and blood loss assessment. Integrating these previously separate digital solutions provides the added benefit of a more efficient, streamlined workflow for hospitals notes Stryker.

Nevro Receives CE Mark In Europe for It’s HFX iQ™ Spinal Cord Stimulation System

Nevro notes HFX iQ is the first and only SCS system with artificial intelligence (AI) technology that combines high-frequency (10 kHz) therapy built on landmark evidence that uses ongoing cloud data insights to deliver personalized pain relief

Recor Medical Reports: CMS Grants Distinct TPT Device Code and Category to Recor Medical for Ultrasound Renal Denervation

The approval of TPT offers incremental reimbursement payments for outpatient procedures performed with ultrasound renal denervation for Medicare fee-for-service beneficiaries. It becomes effective January 1, 2025, and is expected to remain effective for up to three years notes Recor Medical.

Jupiter Endovascular Reports | 1st U.S. Patient Treated with Jupiter Shape-shifting Thrombectomy Device

“Navigation challenges during endovascular procedures are often underappreciated and have led to under-adoption of life-saving procedures, such as pulmonary embolectomy. We have purpose-built our Endoportal Control technology to solve these issues and make important endovascular procedures accessible to more clinicians and their patients who can benefit from them,” said Carl J. St. Bernard, Jupiter Endovascular CEO. “This first case in the U.S. could not have gone better, and appears to validate the safety and performance we are seeing in our currently-enrolling European SPIRARE I study.”