FDA Form 3356 is the registration and listing form for establishments that handle human cells, tissues, and cellular and tissue-based products (HCT/Ps). You submit it electronically through the FDA’s eHCTERS portal within five days of beginning operations, and there is no filing fee. The form captures your facility information, the tissue product types you handle, and the specific manufacturing activities performed at each location.
Who Has to File
Any domestic or foreign establishment that manufactures HCT/Ps must register with the Center for Biologics Evaluation and Research using Form 3356. “Manufacturing” is defined broadly and covers recovery from a donor, donor screening or testing, processing, storage, labeling, packaging, and distribution. Performing even one of these activities triggers the registration requirement.1eCFR. 21 CFR Part 1271 – Human Cells, Tissues, and Cellular and Tissue-Based Products
Foreign establishments that import HCT/Ps into the United States register the same way, and they must also designate a U.S. agent.2eCFR. 21 CFR 1271.25 – What Information Is Required for HCT/P Listing A facility that only labels or packages tissue under contract for another establishment still has to file its own registration. The obligation follows the activity, not the business arrangement.
Who Is Exempt
Several categories of facilities do not need to register even when human tissue is involved:3eCFR. 21 CFR 1271.15 – Are There Any Exceptions from the Requirements of This Part
- Removing tissue from a patient and reimplanting it into the same patient during the same surgical procedure.
- Using HCT/Ps solely for research or teaching, not for human recipients.
- Receiving or storing HCT/Ps for implantation at your own site, with no recovery, screening, testing, processing, labeling, packaging, or distribution.
- Transporting HCT/Ps as a shipping or carrier company in the ordinary course of business.
- Recovering reproductive cells or tissue and immediately transferring them into a sexually intimate partner of the donor.
- Recovering cells or tissue solely under contract with a registered establishment and sending them directly to that establishment.
Hospitals and surgical centers that only receive tissue from a registered bank and implant it into patients generally fall under the receipt-and-storage exemption. Once a facility starts processing or relabeling that tissue, the exemption no longer applies.
What to Gather Before You Log In
Have the following on hand before opening the portal:
- The legal name of your establishment, the physical address of every location where manufacturing or storage occurs, a direct phone number, and all trade names your business uses.
- The name, email, and phone number of the reporting official who will be the primary contact for FDA correspondence.
- The specific HCT/P categories your facility handles, such as musculoskeletal tissue, ocular tissue, cardiovascular tissue, skin, or reproductive tissue.
- For each product type, the manufacturing activities your facility performs: donor screening, donor testing, recovery, processing, storage, labeling, packaging, or distribution.
- For foreign establishments, the name, address, phone, and email of your designated U.S. agent.
If you operate from more than one location, pull together the address and activity details for each site. eHCTERS has separate fields for additional locations, and having the information ready avoids saving a partial submission.
Filing Through eHCTERS
Form 3356 is submitted through eHCTERS, part of the FDA’s CBER On-Line system. Go to the CBER On-Line login page at accessdata.fda.gov.4Food and Drug Administration. CBER On-Line – Login Screen First-time users create a new account. Passwords need at least 15 characters, are case-sensitive, and expire every 60 days. The system uses multi-factor authentication at each login.
Once you are in, select eHCTERS from the list of CBER applications. The portal walks through the form’s sections with dropdown menus and text fields. Take care to link each manufacturing activity to the correct product category; mismatching them is an easy error when a facility handles several tissue types. Review the summary screen, then move to the certification page and submit.5Food and Drug Administration. Tissue Establishment Registration
Electronic filing is the default. If you believe you qualify for a waiver, you can request one from FDA and, if granted, complete a paper Form 3356 and mail it in. Most establishments file electronically.
After You Submit
The system generates a confirmation notification, and your establishment is assigned an FDA Establishment Identifier (FEI). That FEI is permanent and tracks your facility across future correspondence, inspections, and import activity, so keep it accessible.6Food and Drug Administration. Electronic Human Cell and Tissue Establishment Registration System – Latest System Changes
Registration is not an FDA approval. The agency states that accepting a registration and listing does not constitute an approval, license, or finding of compliance.5Food and Drug Administration. Tissue Establishment Registration Registered establishments are subject to inspection, and FDA uses the database to prioritize and schedule those inspections. You remain independently responsible for current good tissue practice, donor eligibility rules, and the rest of 21 CFR Part 1271.
If an establishment fails to register or skips its annual update, FDA considers the establishment in violation, which can lead to enforcement action.7Food and Drug Administration. Establishment Registration and Listing for Human Cells, Tissues and Cellular and Tissue-Based Products (HCT/Ps) Questions and Answers
Deadlines and Updates
A new establishment registers and submits its HCT/P list within five days of beginning operations.8eCFR. 21 CFR 1271.21 – When Do I Register, Submit an HCT/P List, and Submit Updates “Beginning operations” means the date your facility first performs any covered activity, whether that is recovery, processing, storage, or another step. The clock starts with the first activity, not when the facility is fully operational.
Annual Update Every December
Every registered establishment updates its registration annually in December, and product listings can be refreshed at the same time.8eCFR. 21 CFR 1271.21 – When Do I Register, Submit an HCT/P List, and Submit Updates Missing the December window puts the establishment in violation.
Changes That Cannot Wait
Some changes trigger a 30-day amendment requirement. If your establishment’s ownership or physical location changes, or your U.S. agent’s contact information changes, amend the registration within 30 calendar days.9eCFR. 21 CFR 1271.26 – When Must I Amend My Establishment Registration
HCT/P listing changes follow a different schedule. Adding a new product type, discontinuing a product, or resuming distribution of a discontinued product must be reported at the time of the change or by the next June or December, whichever comes first. When discontinuing a product, include the date of discontinuance; FDA requests but does not require the reason. For foreign establishments, changes to the U.S. agent’s name, address, phone, or email also need to be reported within 30 calendar days.2eCFR. 21 CFR 1271.25 – What Information Is Required for HCT/P Listing
What It Costs
FDA does not charge a fee to register an HCT/P establishment or to list products through Form 3356. The only cost is the reporting official’s time. Some states impose their own tissue bank licensing requirements with separate fees, so check with your state health department for any state-level registration that applies on top of the federal filing.