SUMMARY OF FDA REGULATION OF MEDICAL DEVICES

The U.S. Food and Drug Administration (FDA) regulates medical devices to assure their safety and effectiveness and develops, and carries out a national program designed to control unnecessary exposures to, and assure safe and efficacious use of, ionizing and non-ionizing radiation-emitting electronic products. The Center for Devices and Radiological Health (CDRH) is the component within the FDA that is responsible for this program.

Most of FDA's medical device and radiation-emitting product regulations are in Title 21 (Code of Federal Regulations)CFR Parts 800-1299.

A ‘medical’ device is:

• "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:

  • recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,

  • intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or

  • intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of it's primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes."

  Code of Federal Regulations CFR Title 21, Volume 8 Revised as of 

  April 1, 2001

        CITE: 21CFR892.6500, Page 505-506

        TITLE 21--FOOD AND DRUGS

        CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND

        HUMAN SERVICES

        PART 892--RADIOLOGY DEVICES--Table of Contents

Subpart G--Miscellaneous Devices

Sec. 892.6500

Personnel protective shield.

    (a) Identification. A personnel protective shield is a device 

intended for medical purposes to protect the patient, the operator, or 

other persons from unnecessary exposure to radiation during radiologic 

procedures by providing an attenuating barrier to radiation. This 

generic type of device may include articles of clothing, furniture, and 

movable or stationary structures.

    (b) Classification. Class I (general controls). The device is exempt 

from the premarket notification procedures in (emphasis added)

Class I - General Controls

Class I devices are subject to the least regulatory control. They present minimal potential for harm to the user and are often simpler in design than Class II or Class III devices. Class I devices are subject to "General Controls" as are Class II and Class III devices.

General controls include:

1. Establishment Registration (use FDA Form 2891) of companies which are required to register under 21 CFR Part 807.20, such as manufacturers, distributors, repackages and relabelers. Foreign establishments, however, are not required to register their establishments with FDA.

2. Medical Device Listing (use FDA Form 2892) with FDA of devices to be marketed.

3. Manufacturing devices in accordance with Good Manufacturing Practices (GMP) in 21 CFR Part 820.

4. Labeling devices in accordance with labeling regulations in 21 CFR Part 801 or 809.

5. Submission of a premarket notification [510(k)] before marketing a device.

Examples of Class I devices include elastic bandages, examination gloves, and hand-held surgical instruments.

Most Class I devices are exempt from the premarket notification and/or good manufacturing practices regulation. Information on Class I exempt devices is located under the heading What are Class I/II Exemptions?.

        TITLE 21--FOOD AND DRUGS

  CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND 

  HUMAN SERVICES

  PART 807--ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR

  MANUFACTURERS AND

  NITIAL IMPORTERS OF DEVICES

        Subpart D--Exemptions

        Sec. 807.65  

Exemptions for device establishments.

    The following classes of persons are exempt from registration in 

accordance with Sec. 807.20 under the provisions of section 510(g) (1), 

(2), and (3) of the act, or because the Commissioner has found, under 

section 510(g)(4) of the act, that such registration is not necessary 

for the protection of the public health:

    (a) A manufacturer of raw materials or components to be used in the 

manufacture or assembly of a device who would otherwise not be required 

to register under the provisions of this part.

    (b) A manufacturer of devices to be used solely for veterinary 

purposes.

    (c) A manufacturer of general purpose articles such as chemical 

reagents or laboratory equipment whose uses are generally known by 

persons trained in their use and which are not labeled or promoted for 

medical uses.

    (d) Licensed practitioners, including physicians, dentists, and 

optometrists, who manufacture or otherwise alter devices solely for use 

in their practice.

    (e) Pharmacies, surgical supply outlets, or other similar retail 

establishments making final delivery or sale to the ultimate user. This 

exemption also applies to a pharmacy or other similar retail 

establishment that purchases a device for subsequent distribution under 

its own name, e.g., a properly labeled health aid such as an elastic 

bandage or crutch, indicating ``distributed by'' or ``manufactured for'' 

followed by the name of the pharmacy.

    (f) Persons who manufacture, prepare, propagate, compound, or 

process devices solely for use in research, teaching, or analysis and do 

not introduce such devices into commercial distribution.

    (g) [Reserved]

    (h) Carriers by reason of their receipt, carriage, holding or 

delivery of devices in the usual course of business as carriers.

    (i) Persons who dispense devices to the ultimate consumer or whose 

major responsibility is to render a service necessary to provide the 

consumer (i.e., patient, physician, layman, etc.) with a device or the 

benefits to be derived from the use of a device; for example, a hearing 

aid dispenser, optician, clinical laboratory, assembler of diagnostic x-

ray systems, and personnel from a hospital, clinic, dental laboratory, 

orthotic or prosthetic retail facility, whose primary responsibility to 

the ultimate consumer is to dispense or provide a service through the 

use of a previously manufactured device.

Possible similar device registered

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service  Food and Drug Administration
Center for Devices and Radiological Health
Rockville, Maryland 20850

ESTABLISHMENT REGISTRATION AND MEDICAL DEVICE LISTING

 INTRODUCTION

Section 510 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) requires that domestic establishments engaged in the manufacture, preparation, propagation, compounding, assembly, or processing of medical devices intended for human use and commercial distribution register their establishments with the Food and Drug Administration (FDA). This is accomplished by completing FDA Form 2891, "Initial Registration of Device Establishment." The term "device" is defined in section 201(h) of the FD&C Act and includes all in vitro diagnostic products and in vitro diagnostic biological products not subject to licensing under section 351 of the Public Health Service Act (42 U.S.C. 262). Foreign manufacturers commercially distributing devices in the United States (U.S.) are not required to register; however, they are encouraged to do so. Refurbishers/reconditioners are not required to register or list, however, FDA will accept voluntary registration and listings from firms that wish to be registered with FDA.

Section 510 of the Federal Food, Drug, and Cosmetic Act requires both domestic and foreign manufacturers to list their devices with FDA if the devices are in commercial distribution. Devices are listed by their classification name on form FDA 2892. A classification name is a generic category the device being listed would be placed in.

Neither registration nor listing constitutes FDA clearance or approval for marketing or commercial distribution in the U.S. Unless the device is exempt from the clearance or approval process, a premarket notification submission [510(k)] or a premarket approval application (PMA) is required before commercial distribution commences.

Registration of a device establishment or submission of device listing does not in any way denote approval of the establishment or its products by FDA. A firm may not advertise or distribute promotional material with any statement relating to its registration with FDA. Any labeling or other representation that creates an impression of official FDA approval is misleading and constitutes misbranding as referenced in section 301 of the FD&C Act and
21 CFR 807.39.

The regulations for registration and listing are in 21 CFR Part 807.

How To Register

To register an establishment, form FDA 2891, "Initial Registration of Device Establishment," must be completed. To order copies of the form see Appendix 2.

When registering, consider the following points:

• Submit all four (4) copies of the original registration form to the Center for Devices and Radiological Health (CDRH) to the address printed on the form.

• Do not use post office (P.O.) box numbers as addresses in Sections "A or B" of form FDA 2891. FDA will not accept P.O. box numbers. The actual street address must be used unless the only street address is a rural route box number or a highway mile number.

Where To Submit

All copies of form FDA 2891 are to be submitted to the following address:

Food and Drug Administration
Center for Devices and Radiological Health (HFZ-308)
9200 Corporate Boulevard
Rockville, Maryland 20850
Telephone No. 301-827-4555 (Press 3, then press 1 for registration and listing)

Keep a photocopy of the registration form for your records.

All of the information provided on form FDA 2891 must be in English. When necessary, supplemental sheets can be used to complete or clarify your submission. Supplemental sheets must be letter size (8 ½ x 11 inches or A4) and have typed or printed in the upper right hand corner, the establishment business name from Block 2.

The numbers below refer to the item numbers on form FDA 2891.

1. Registration No. Leave this space blank. The Food and Drug Administration (FDA) will assign a unique registration number to each establishment.

SECTION A. The purpose of this section is to obtain specific information about the registering establishment.

2. Establishment Business Name. Enter the legal name of the establishment involved in registration activity and limit the entry to 50 characters (abbreviate only if necessary).

3. Record Date. Enter the month, day, and year the form is completed using a MM/DD/YYYY date format. All entries must be numeric and two/four digits each as shown below for July 4, 1997:

Mo Day Year
07 04 1997

4. Number and Street. Enter the number and street at which the registering establishment is located. Do not use Postal Box or Rural Route numbers. Limit entry to 60 characters for the street address.

Domestic Establishments:

5. City and Foreign State. Enter the city name in which the establishment is located. Limit entry to 30 characters.

6. State. Enter the two-character State code of the U.S. Postal Service for the State, territory, or possession.

7. ZIP Code +4. Enter the U.S. Postal ZIP Code +4.

8. Foreign Country. Leave blank.

Foreign Establishments:

5. City and Foreign State. Enter the city and foreign state (i.e., province, prefecture, region, territory) names in which the establishment is located. Limit entry to 30 characters, abbreviate if necessary (e.g., Vancouver, B.C.)

6. State. Leave blank.

7. Zip Code/Postal Code. Enter the foreign country Postal Code/Zip Code. Limit entry to 10 characters.

8. Foreign Country. Enter the foreign country name.

Both Domestic and Foreign Establishments:

9. Establishment Type. Space is provided for each designated code for establishment type. Select from the following list of establishment types the appropriate codes that reflect the device activities of the establishment. Definitions for each establishment type appear in Appendix 3. Circle all of the letter designation(s) that apply to the establishment (e.g., M and C, or S and ID, etc.)

* NOTE: A September 1, 1993 Federal Register notice erroneously exempted contract manufacturers and contract sterilizers from registration. That exemption will be revoked.

**NOTE: Since 1995, FDA has exercised its enforcement discretion and is not currently requiring or accepting registration or listing forms from domestic distributors.

***NOTE: Refurbishers/reconditioners are not required to register and list, however, CDRH will accept voluntary registrations and listings. To do so, print or type the letter "K" in one of the empty boxes in Block number 9.

10. Pre-production Registration. To be used only when registering prior to commencing actual production, otherwise check NO. A pre-production registration will be held by CDRH for only one (1) year. After one year CDRH automatically notifies the firm that it must register as an active firm. If the establishment does not notify CDRH that it has begun an activity that requires registration, the pre-production registration form will then be archived without further processing. The establishment must notify CDRH by letter when their status has changed to "in production or active" and submit a Device Listing form, FDA 2892, if one is required. At that time the initial registration form will be further processed and a registration number issued.

SECTION B. The purpose of this section is to obtain information about the owner or operator of the registering establishment.

Both Domestic and Foreign Establishments

11. Owner/Operator Business Name. Enter the business trading name of the corporation, subsidiary, affiliated company, or partnership that is the owner or operator of the registering establishment. Only enter the proprietor's name if no other business trading name exists. Limit entry to 50 characters (abbreviate only if necessary).

12. Owner/Operator I.D. Fill in if an Owner or Operator I.D. number has been previously issued by CDRH. Leave this space blank if no identification number has been issued by CDRH. CDRH will assign an identification number and provide this to the registrant.

13. Number and Street. Enter the number and street at which the owner or operator is located. Limit entry to 60 characters for the street address.

Domestic Establishments

14. City and Foreign State. Enter the city in which the owner or operator is located. Limit entry to 30 characters.

15. State. Enter the two-character State code of the U.S. Postal Service for the State, territory, or possession.

16. ZIP Code +4. Enter the U.S. Postal ZIP Code +4.

17. Foreign Country. Leave blank.

18. Telephone Number. Enter the area code and/or country plus city codes and telephone number, including extension, only if the number is different from that of the official correspondent. If there is a toll free (800 or 888) number, CDRH requests it be given.

Foreign Establishments

14. City and Foreign State. Enter the city and foreign state names (i.e., province, prefecture, region, territory) in which the owner or operator is located. Limit entry to 30 characters.

15. State. Leave blank.

14. Zip Code/Postal Code. Enter the foreign country Postal Code. Limit entry to 10 characters.

17. Foreign Country. Enter the foreign country name.

18. Telephone Number. Enter the country code, city code and telephone number, including extension, only if the number is different from that of the official correspondent.

SECTION C. The purpose of this section is to identify the individual designated as official correspondent. FDA will direct important correspondence to the individual identified in this section.

19. Official Correspondent/U.S. Designated Agent. Enter the name of the individual designated as the official correspondent for registration and listing purposes. The name must be neatly printed or typed.

The requirement in 21 CFR 807.40 to have a U.S. Designated Agent has been placed in abeyance, as of July 23, 1996, so do not provide this information. There is no existing requirement to employ a U.S. Designated Agent, so foreign establishments do not need to hire one. The Official Correspondent requirement is not in abeyance and must be completed.

20. Registration Number. Leave blank since this was intended for the registration number of the U.S. Designated Agent.

21. Business Name. Enter the name of the establishment, owner or operator, or other place of business, as applicable, with which the official correspondent is associated. This may be the same name as, or different from, Block 2 or Block 11. Limit entry to 50 characters.

22. Number and Street. Enter the number and street or post office box of the official correspondent's place of business. A Post Office box number is acceptable in Section C, since this address will be used for FDA mailings. Limit entry to 60 characters for the street address.

Domestic Establishments:

23. City. Enter the city name in which the official correspondent's place of business is located. Limit entry to 30 characters.

24. State. Enter the two-character State code of the U.S. Postal Service for the State, territory, or possession.

25. ZIP Code +4. Enter the U.S. Postal ZIP Code +4.

Foreign Establishments:

23. City, Foreign State and Country. Enter the city, state and country name in which the official correspondent’s place of business is located. Limit entry to 30 characters. The form does not have a separate item for State and Country because the U.S. Designated Agent provision required all official correspondent’s to be located in the United States. While this provision is in abeyance, please provide the Foreign State and Country information in this block or on a supplemental page.

24. State. Leave blank.

25. Postal Code/ZIP Code. Enter the foreign country Postal Code. Limit entry to 10 characters.

Both Domestic and Foreign Establishments:

26. Telephone Number. Enter the area code and/or country plus city codes and telephone number, including extension, of the official correspondent, as it would be dialed from the U.S. If there is a toll free (800 or 888) number, CDRH requests it be given.

27. FAX Number. Enter the area code and/or country plus city codes and the FAX machine number of the official correspondent, as it would be dialed from the U.S.

SECTION D. The purpose of this section is to record other names for the registering establishment that relate to device activities and that are different from the name entered in Section A.

28. Other Business Trading Name. Enter any other establishment names used, using one of the six blocks for each name. This can include "d.b.a." (doing business as) names. Limit entry in each block to 50 characters. Use an attached sheet if the number of names exceeds six. Do not include the names of distributors for whom this establishment makes devices. Do not list registered trademarks in use by the firm.

SECTION E. The signature (29) and title (30) of the designated official correspondent must appear in this section.

Exhibit 1: FDA Form 2891

INSTRUCTIONS FOR COMPLETION OF "ANNUAL REGISTRATION OF DEVICE ESTABLISHMENT," FORM FDA 2891a

Introduction

Each year active, registered establishments will receive a pre-printed annual registration form FDA 2891a from CDRH. This form is to be used to notify FDA of changes to the current registration information for the establishment. Only those items needing changes or corrections need be completed. This form must be returned to CDRH even if no changes have occurred. The form comes with three parts and is pre-addressed for return to CDRH. After detaching Parts 1 and 3 and retaining for your company files, fold Part 2 in half and it becomes a mailer requiring only the addition of first class or air mail postage.

All of the information provided on form FDA 2891a must be in English. When necessary, supplemental sheets can be used to complete or clarify your submission. Supplemental sheets must be letter size (8 ½ x 11 inches or A4) and have typed or printed in the upper right hand corner, the registration number of the firm.

The letters below refer to the block letters on form FDA 2891a.

A. Type of Submission. Complete block A by checking one box according to the following instructions:

No change. Check this box if all of the information printed to the left of Blocks B, C, D, E, or F is correct and complete. Check the "NO CHANGE" box on the outside of the mailer.

Correction. Check this box if any information printed to the left of Blocks B, C, D, E, or F is incorrect or incomplete. Make corrections, additions, or deletions in the corresponding blocks. Check the "CHANGE" box on the outside of the mailer.

No Longer Device Establishment. Check this box if the establishment is no longer engaged in activities (see establishment types in Appendix 3) which require it to be registered as a medical device establishment, but the establishment is still in existence for other activities or purposes. If any of the information printed to the left of Blocks B, D, or F is incorrect, this information should be corrected. Check the "CHANGE" box on the outside of the mailer.

Out of Business. Check this box if the establishment has ceased to exist as an identifiable organization. Make changes to information printed to the left of Blocks B, C, D, E, or F so that the information reflects the current information at the time the establishment went out of business. Check the "CHANGE" box on the outside of the mailer.

B. Registered Establishment Information. Indicate any changes or corrections to the information in block B. If the establishment type has changed to M, R or S, then a new or initial Device Listing form FDA 2892 must be submitted for all the medical devices marketed by the firm that are affected by this change. Previously listed devices may also need to have updated forms FDA 2892 submitted.

C. Establishment Type. Indicate any changes or corrections to the information in block C. (See Establishment Types in Appendix 3).

D. Owner/Operator Information. Indicate any changes or corrections to the information in block D.

E. Other Business Trading Names. Indicate any changes or corrections to the information in block E.

F. Official Correspondent/U.S. Designated Agent Information. Indicate any changes or corrections to the information in block F. The U.S. Designated Agent provision is in abeyance, as of July 23, 1996, so do not provide this information.

G. Official Correspondent Signature and Title Line. The official correspondent must sign, date, and print or type title.

Mailing Instructions

After Part 2 of the form is completed, it should be folded in half with the CDRH address on the outside. Tape (DO NOT STAPLE) where indicated. Check the "CHANGE" or "NO CHANGE" box as appropriate on front of the mailer. Affix first-class or air mail postage and mail. Retain Part 1 for your records, do not return Part 1 to CDRH.

Exhibit 2: FDA Form 2891a - Front Page