# Presentation: 048382

## How to Register A Medical Device Establishment and List Devices With the FDA

- Presented by Bryan H. Benesch
- Office of Compliance, CDRH
- April 2004

## Regulatory Authority

- Sections 510 of the Food, Drug and Cosmetic Act As Amended requires establishment registration and device listing

## R&L Regulations

- 21 CFR Part 807, subparts A-D
- A: Definitions
- B: Procedures for Domestic Device Establishments
- C: Registration Procedures for Foreign Device Establishments
- D: Exemptions

## Who Must Register and List?

## Registration Requirements

- Initial domestic establishment registration within 30 days of starting commercial distribution of a device.
- Foreign establishments must register before importing or offering for import devices to the United States
- Submit form FDA 2891
- Renew registration annually using form FDA 2891a (see 807.21 for mailing schedule)

## Foreign Establishment Requirements

- FDA Modernization Act (FDAMA) of 1997 makes establishment registration mandatory and adds requirement to appoint a United States agent
- Effective February 11, 2002

## United States Agent Requirement

- All foreign establishments shall appoint a _**single**_ United States agent
- Must notify FDA within five days of appointing or changing United States agent
- United States agent must reside or have a physical place of business in the United States - no Post Office boxes or mail drops allowed

## United States Agent Responsibilities

- Assist FDA with scheduling of inspections
- Assist FDA with communications
- Accept information or documents that FDA is unable to provide directly to the foreign establishment
- Respond to questions concerning products being imported or offered for import
- May act as Official Correspondent

## Device Listing Requirements

- Device listing by domestic establishments within 30 days of starting commercial distribution of a device.
- Foreign establishments must list before importing or offering for import devices to the United States.
- Submit form FDA 2892.
- One device listing for each type of device (not each model, catalog number, brand name).

## Device Listing Updates

- Semi-annual review of all information is required in June and December.
- Updates due in June, December, or at time of change.
- Only certain items of the initial information requires updating.
- Update information using new FDA 2892 or a letter when changing large numbers of records.

## Registration Updates

- Update information by submitting annual registration form FDA 2891a, or by letter rest of time.

## What Registration Data Has to Be Updated?

## What Listing Data Has to Be Updated?

## Where Do My Pieces of Paper Go?

- You mail forms FDA 2891, 2891a, 2892, U.S. agent notification letter to CDRH
- We receive and accept or return them
- If accepted, we send you a letter with your newly assigned owner/operator number
- We send the 2891 to appropriate FDA District Office
- District reviews form, issues registration number and sends form back to CDRH
- CDRH enters data and sends you your registration number

## Top Problems - Form 2891

- An official version of the form was not used.
- An illegible photocopy of the form was submitted.
- A post office box was used for the establishment's address, instead of the required street address.
- The official correspondent fails to sign the form or enter his or her title.

## Top Problems - Form 2891

- The establishment fails to submit a device listing form (2892) with its initial registration form (2891).
- The "establishment type" section is not filled out correctly.
- Information on the establishment's owner/operator is missing or incomplete.
- Sections of the form are incomplete.

## Top Problems - Form 2892

- A photocopy of the form was submitted. Because each form is uniquely numbered, only an original copy is acceptable.  This document ID number is the "device listing number." It is required when importing a medical device into the United States.
- The classification number is missing or unclear. This is the three letter product code that FDA assigns to each type of medical device.
- The official correspondent fails to sign the form.
- The owner/operator listed more than one classification name and number on the form. Each form can only include a single product type.

## Top Problems - Form 2892

- The form is a duplicate of a previously submitted form for the same classification number. This occurs when a new brand name or model number is added to an existing product line. FDA does not require a new form every time a new brand name, model number, or catalog number is added or changed.
- Sections of the form are incomplete.
- Missing, incomplete or incorrect establishment information or owner/operator information.

## Sources of Registration and Listing Information

- 1.  Registration and Listing for Firms	_http://www.fda.gov/cdrh/reglistpage.html_
- 2.  Establishment Registration (part of Device Advice)	_http://www.fda.gov/cdrh/devadvice/341.html_
- 3.	Medical Device Listing (part of Device Advice)	_http://www.fda.gov/cdrh/devadvice/342.html_
- 4.	Releasable Establishment Registration and Device Listing Files 	_http://www.fda.gov/cdrh/comp/estregls.html_

## Sources of Registration and Listing Information

- 5.	Product Code Classification Database			_http://www.fda.gov/cdrh/prodcode.html_
- 6.	Use of PDF Version of Form FDA 2891 Initial Registration of Device Establishment
- 		_http://www.fda.gov/cdrh/comp/fda2891.html_
- 7.	Use of PDF Version of Form FDA 2892 Device Listing
- 		_http://www.fda.gov/cdrh/comp/fda2892.html_

## How to Contact R&L Program Office

- Registration and Listing ProgramOffice of ComplianceCenter for Devices and Radiological Health9200 Corporate Blvd., HFZ-308Rockville, MD 20850-4015Tel: 301-827-4555, press 3
- E-mail for forms and status requests: reglist@cdrh.fda.gov
- E-mail for policy questions and import detention issues: rlprogram@cdrh.fda.gov