The US FDA has published a detailed Q & A about the end of the compliance and enforcement policy for certain human cells, tissues or cellular or tissue based products (HCT/Ps).
As stated in the guidance, Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use, last updated in July 2020, FDA announced its policy on compliance and enforcement policy for certain HCT/Ps in order to to give manufacturers time to determine if they need to submit an IND or marketing application in light of this guidance and if such an application is needed, to prepare the IND or marketing application.
As per the above guideline, after May 31, 2021, FDA no longer intends to exercise enforcement discretion with respect to the IND and the premarket approval requirements as described in its Compliance and Enforcement Policy Regarding Certain Regulatory Requirements.
Because the FDA does not comment on its compliance or enforcement approach, it is unclear what the approach will be, to its compliance and enforcement policy after 31 May 2021 for HCT/Ps that are subject to this policy.
FDA expects all establishments that manufacture HCT/Ps regulated as drugs or biological products to have an approved biologics license application (BLA) or an investigational new drug application (IND) in effect.
An approved BLA is required to lawfully market these products. While in the development stage, such products may be distributed for clinical use in humans only if the sponsor has an investigational new drug application (IND) in effect.
A product that requires but lacks premarket approval may not be lawfully marketed, including when a sponsor has an IND or is pursuing an IND or BLA.
If after May 31, 2021, you continue to market/offer for sale an HCT/P that requires but lacks premarket approval as a drug or biological product, you do so at your own risk.
In the Q&A, there is guidance on where you can direct questions as to how your HCT/P is appropriately regulated after 31 May 2021.
Source: FDA website