What it is
An amniotic membrane device is a thin piece of processed human tissue, derived from the amniotic membrane of the placenta, that an eye doctor may place on the surface of the eye. Some are held in place with a ring or similar support, and some are preserved in different ways.
Regulation depends on the product. Some amniotic membrane devices are regulated by the FDA as human tissue products, which is a different pathway from a drug or a traditional medical device. Whether a particular product has been cleared, approved or simply registered depends on how it is made and how it is described.
These distinctions matter. "FDA cleared" and "FDA approved" are not the same, and neither is the same as being registered or regulated as a tissue product. Amniotic membrane devices are not the same as amniotic eye drops or serums, and most of those are not FDA-approved as drugs. They are also not stem-cell treatments, since processed amniotic tissue generally contains no living stem cells.
How it’s traditionally been approached
Amniotic membrane tissue has long been used by eye care professionals in clinical settings for the surface of the eye. It has generally been handled by clinicians rather than purchased by patients on their own.
Other approaches that are often discussed for dry eye treatment include artificial tears, lifestyle and environment changes, and in some cases autologous serum tears. Autologous serum tears are compounded by a pharmacy from the patient's own blood and are not an FDA-approved drug.
Which approach is considered depends on the individual, and a licensed clinician decides after an evaluation. No one approach is right for everyone, and each has its own considerations.
How the right eye doctor may help
The right eye doctor may start by listening to your symptoms and history, examining the surface of your eyes, and talking through which options, if any, could be worth considering. A visit is a conversation, and nothing about it is guaranteed to lead to a particular product.
If an amniotic membrane device comes up, you can ask how it is regulated: is it cleared, approved, or regulated as a human tissue product? Ask the provider to explain what that means in plain language, and whether it applies to the specific product they are describing.
It can also help to ask about the product's source, how it is processed, what the total cost may be, whether insurance may or may not cover it, and what other options exist. A good provider will welcome these questions and will not promise results.
The whole-person view
Eye discomfort, sleep, stress and mood can influence one another. Ongoing irritation can wear on your focus and patience, and stress can make bodily sensations feel more noticeable. Looking at the whole person is a reasonable way to think about comfort.
Some people explore body-based support such as Somatic Experiences, or talk therapy through Therapists.plus, alongside their eye care. These are complements to medical care, not replacements, and no approach needs to be dismissed in favor of another.
Keep in mind
- Only a licensed eye doctor can decide whether any product or procedure is appropriate for you after an evaluation.
- FDA clearance, approval and tissue-product regulation are different things, so ask which one applies to a specific product.
- Sudden vision changes, severe eye pain or eye injury may be urgent, so call 911 for emergencies; if you are in emotional crisis, call or text 988.
- This page is educational only, does not diagnose or treat, and cannot promise any result.
Not sure where to start? Answer a few gentle questions and choose who you’d like to hear from.
Frequently asked questions
What does amniotic membrane device FDA clearance mean?
FDA clearance generally refers to a regulatory pathway for certain medical devices, and it is not the same as FDA approval of a drug. Some amniotic membrane devices are instead regulated as human tissue products, which is a different pathway. Ask your eye doctor which category applies to the specific product.
Are amniotic membrane devices FDA approved?
Not necessarily, and the wording matters. Some are regulated as human tissue products rather than approved as drugs. Ask the provider exactly how the product is regulated and request that they explain it.
Are amniotic eye drops and serums FDA approved?
Most amniotic-derived eye drops and serums are not FDA-approved as drugs. This is different from the regulation of amniotic membrane devices. Ask an eye doctor about the product's source, processing and regulatory status before use.
Is an amniotic membrane device a stem-cell treatment?
No. Most processed amniotic tissue products contain no living stem cells after processing. Be cautious of any marketing that calls them stem-cell treatments, and ask your provider what the product actually contains.
Can an amniotic membrane device help with dry eye treatment?
It may be something an eye doctor considers as part of dry eye treatment, but no result is guaranteed. Whether it is appropriate depends on an evaluation of your eyes and health history. Ask about alternatives and what to expect.
What should I ask my eye doctor about an amniotic product?
Ask about the specific product, where it comes from, how it is processed, how the FDA or other regulators classify it, and the total cost. Also ask about other options and who will follow up with you. A licensed eye doctor's evaluation should come before any use.
Educational resource. Placenta-Derived Eye Serum shares general information and connects people with independent eye doctors. It is not medical advice, diagnosis or treatment. Talk with a licensed professional about your health.