Registration
Registration is a notification. An establishment tells FDA that it exists, where it operates, and what products it handles. It is administrative.
FDA does not evaluate the product's safety or effectiveness as part of registration. Registration does not constitute endorsement, and FDA has stated this directly. A registered establishment is one that has filed paperwork it is required to file.
Approval
Approval is a determination. For a biologic, it follows a biologics licence application containing preclinical and clinical data, manufacturing detail, and labelling. FDA reviews that submission and determines whether the product is safe and effective for a specified indication.
Approval is indication-specific. A product approved for one use is not thereby approved for another.
Why the conflation happens
"FDA-registered" appears in marketing because it sounds like "FDA-approved" to a reader who has no reason to know the difference. Some uses are careless; some are not. FDA has issued warning letters to companies in the regenerative medicine space over claims in this area.
Connective tissue allografts under Section 361 are FDA-registered, not FDA-approved. A clinic stating this plainly is describing the situation accurately. A clinic implying approval is not.
What to do with this
Ask directly: is this product FDA-approved for what you are proposing to use it for? The answer for Section 361 HCT/Ps is no, and a straightforward provider will say so and explain what that does and does not mean.
Evasion on this question is itself informative.
This article covers general science and published research. Whether any approach is appropriate for you is a clinical question, answered by a licensed provider through a good-faith exam.
Movera Wellness Institute. Medical services are provided by licensed California practitioners. Supervising physician: Dr. Arnold S. Kremer, DO (CA license #20A4242).