What a tissue product register actually records

A register with an unusual field in it

Establishments that handle human cells and tissue have to register with the agency and list what they handle. That much is ordinary.

One field is not ordinary. The listing asks the company to say whether each product meets a specific set of regulatory criteria.

Those criteria are the four-part test that decides how a product is regulated, covered separately on this site. The register records the company's own answer to it.

So the file holds two different kinds of thing: facts about an address and a signature, and a legal position taken by the person filing.

The clock on registering

The deadlines are short and tied to activity rather than to a licensing decision.

A company must "register and submit a list of every HCT/P that your establishment manufactures within 5 days after beginning operations," or within 30 days of the rule's effective date, whichever is later.

Then it is annual. "You must update your establishment registration annually in December," and the listing update can be done at the same time.

Listing updates follow changes rather than the calendar. Where a listed change has occurred, the update goes in at the time of the change, or in the next June or December, whichever comes first.

What the registration itself contains

The registration is a short set of identifying facts, and one of them is a personal attestation.

It carries the legal names of the establishment and each physical location, with street address, telephone number, email address and postal code.

It names a reporting official, with that person's address, telephone number, email address and title.

And it carries "A dated signature by the reporting official affirming that all information contained in the establishment registration and HCT/P listing form is true and accurate, to the best of his or her knowledge."

A foreign establishment names two more parties

Where the establishment is outside the United States, the registration reaches further, and the extra fields are the useful ones.

It must submit the name, address, telephone number and email address of each importer known to it, and the name of each person who imports or offers the product for import.

It must also name a United States agent. "The United States agent must reside or maintain a place of business in the United States."

That United States agent has duties, including to "assist FDA in scheduling inspections of the foreign establishment." Changes to its details are reported "within 30 calendar days of the change."

Service on the United States agent counts

One sentence in that provision decides what the arrangement is actually for.

If the agency cannot contact the foreign establishment directly or expeditiously, it may provide information or documents to the United States agent instead.

The regulation then says what that means: "such an action is equivalent to providing the same information or documents to the foreign establishment."

So the United States agent is a point of service, not a formality. A foreign company cannot be out of reach while it holds a registration.

The listing, and the declaration inside it

The product list is broader than a catalog of what a company sells.

It must include "all HCT/P's (including the established name and the proprietary name) that you recover, process, store, label, package, distribute, or for which you perform donor screening or testing."

A company that only stores or only screens still lists the product. The list follows the function performed, not ownership of the finished item.

And then the declaration: the filer must also state whether each product meets the criteria in the section that decides how it is regulated.

What acceptance does not mean

The subpart answers the obvious next question itself, in a single sentence sitting under a heading about registration numbers.

First the number: "FDA will assign each location a permanent registration number."

Then the disclaimer. Acceptance of a registration and listing form "does not constitute a determination that an establishment is in compliance with applicable rules and regulations."

It continues, "or that the HCT/P is licensed or approved by FDA." A separate article here makes the same point about a different register, and the shape of the answer is worth noticing in both.

The file is open, and a waiver is not a pause

Two smaller provisions round the subpart out, and both affect what an outside reader can expect to find.

Registrations filed on the prescribed form "will be available for public inspection" through a public query site, or in person at the agency's public reading room.

The regulation lists what kind of compiled information is disclosable, including a list of all products, a list of those manufactured by each establishment, and a list of those discontinued.

Filing is electronic, and a waiver from that format can be requested. But "Submission of a request for waiver does not excuse timely compliance with the registration and listing requirements."

How to read a register like this

The most transferable idea here is the difference between a recorded fact and a recorded claim.

An address, a signature and a date are facts about a filing. A statement that a product meets a regulatory test is a position the filer has taken about its own product.

A register that contains both is still worth consulting, because it makes the position visible and dated. It is not a place where somebody else has checked the answer.

And the subpart says as much in its own words. Acceptance of the form is not a compliance determination and not an approval, which is what makes reading the underlying rules necessary rather than optional.

Sources

Each document below is named as it names itself, with the date printed on that document rather than the day it was read.

1. Title 21 Code of Federal Regulations section 1271.25, What information is required for establishment registration and HCT/P listing — the establishment fields and the reporting official's dated signature at (a), the additional importer and United States agent requirements for foreign establishments at (a)(5) and (a)(6) including the equivalence of service on the United States agent, the contents of the product listing and the required statement of whether each product meets the criteria in section 1271.10 at (b), and the listing update contents at (c) — Electronic Code of Federal Regulations, Office of the Federal Register, August 2016
2. Title 21 Code of Federal Regulations section 1271.27, Will FDA assign me a registration number — the assignment of a permanent registration number to each location at (a), and the statement at (b) that acceptance of an establishment registration and HCT/P listing form does not constitute a determination that an establishment is in compliance with applicable rules and regulations or that the product is licensed or approved — Electronic Code of Federal Regulations, Office of the Federal Register, January 2001
3. Title 21 Code of Federal Regulations section 1271.21, When do I register, submit an HCT/P list, and submit updates — the five-day deadline after beginning operations at (a), the annual December registration update at (b), and the rules on when a listing update is required at (c) — Electronic Code of Federal Regulations, Office of the Federal Register, November 2004
4. Title 21 Code of Federal Regulations section 1271.37, Will establishment registrations and HCT/P listings be available for inspection, and how do I request information on registrations and listings — the availability of filed registrations for public inspection through the center's public query web site or in person at the agency's public reading room, and the illustrative list of compiled information available for public disclosure — Electronic Code of Federal Regulations, Office of the Federal Register, July 2023
5. Title 21 Code of Federal Regulations section 1271.23, How is a waiver from the electronic format requirements requested — the availability of a waiver from electronic submission, the statement that submitting a waiver request does not excuse timely compliance with the registration and listing requirements, and the contents and destination of a written request — Electronic Code of Federal Regulations, Office of the Federal Register, August 2016