The following excerpt regarding PRP and FDA approval is from the ISHRS website:

The use of PRP in the United States as part of the clinical process of hair transplantation does not require FDA approval, just as the use of blood transfusion during or after surgery does not require FDA approval. Use of PRP as part of the surgical treatment is defined as a procedure and is not subject to FDA regulation.

However:

In the United States, the device used to prepare PRP must have FDA approval. Centrifuges that separate PRP from whole blood for a medical purpose (e.g., to assist tissue healing) are medical devices covered by the Federal Food, Drug and Cosmetics Act. Federal law requires that manufacturers of medical devices must obtain clearance or approval for the products before offering them for sale. Failure to have premarket approval or clearance for such devices is a violation of U.S. law. Premarket approval requires data showing that a device is safe and effective.

The FDA has not approved PRP as a medication specifically for use in hair transplantation. FDA approval would be based on objective evidence of efficacy (e.g., promoting healing, promoting hair growth) and safety. Claims that PRP is “FDA approved” for use in hair transplantation are incorrect. Advertised claims of PRP efficacy in promoting hair growth may be a violation of FDA protocol regarding medical claims.

David

Secondly, you avoid the stress of excessive growth of hair, curling iron, hot water or a brush. You can also take a break from wet hair, hair loss, no one in the field.

ACell

Permanent hair loss ;)

As I’ve previously mentioned, there is still no data proving that PRP will regrow hair. The best non-surgical hair loss treatment currently available for men is a combination of Rogaine (minoxidil) and Propecia (finasteride). Only Rogaine is proven safe and effective for balding females.

David (TakingThePlunge)

There is still no verifiable data proving that PRP will regrow hair. However, there is some anecdotal information suggesting that some patients have seen positive results.

Currently, Rogaine (minoxidil) is the only hair loss treatment proven safe and effective for female patients. If you have not yet done so, I highly recommend discussing this treatment option with your physician.

David (TakingThePlunge)

At this point, PRP’s potential in fighting hair loss is still being evaluated.

As the article states, “A recent case study on a 26 year old hair loss sufferer suggests that platelet rich plasma can stop and reverse hair miniaturization caused by androgenic alopecia or male pattern baldness”. This statement suggests that PRP may be an effective preventative treatment. However, these claims remain unproven.

David (TakingThePlunge)