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Revisiting Establishment Registration


Posted by mddiadmin on September 1, 2001

Originally Published MDDI September 2001

HELP DESK

Revisiting Establishment Registration

Bryan H. Benesch is special assistant to the director in CDRH's Office of Compliance. Prior to accepting this position with the agency, Benesch worked from 1995 to 1999 in the Division of Small Manufacturers Assistance as an expert on medical device establishment registration and device listing regulations.

I have a question regarding the article "Establishment Registration: Keeping Pace With an Evolving Industry" in the March, 2001 issue of MD&DI (p. 140). In the example given on page 140, where an OEM outsources design and manufacturing, the article states, ". . . the OEM needs to be registered and to list the product . . . and the contract manufacturer needs to be registered, but doesn't need to list."

I have a different interpretation of 21 CFR 807 (revised April 1, 2000). Section 807.20(c) says, "registration and listing requirements shall not pertain to any person who: 1) manufactures devices for another party who both initiated the specifications and commercially distributes the device."

I have a client device manufacturer in the United States who is considering outsourcing manufacturing to a foreign company. The U.S. company is the specification developer and the product will be marketed by and under the U.S. company's name. My understanding from 21 CFR 807 is that, in this case, the contract manufacturer would not be required to register or list.

Laura A. Halper, Consultant
The Halper Group (Plano, TX)


The answer is complicated. The example on page 140 of the article correctly explains FDA's policy for registration and listing by contract manufacturers who do not initiate or commercially distribute the device. This policy is in conflict with 807.20(c), however, because an error was made in a September 1993 Federal Register notice that amended this section. It was supposed to be amended to say that only listing requirements did not apply to any person who manufactures devices for another party who both initiated the specifications and commercially distributes the device. There was never any intention by FDA to exempt these kinds of contract manufacturers from establishment registration.

Since this error was made, FDA has indicated in the instruction manual for completing the registration and listing forms, and elsewhere, that we want contract manufacturers to continue to register. However, any contract manufacturer that is solely covered by 807.20(c) versus 807.20(a)(2), cannot be forced to register.

FDA intends to correct this error.

About Help Desk

Help Desk is open for all readers to send in their questions or their solutions to problems other device manufacturers are likely to encounter.

Send questions and/or solutions to Help Desk, MD&DI, 11444 W. Olympic Blvd., Ste. 900, Los Angeles, CA, 90064.

Although every effort is made to ensure the accuracy of this column, neither the experts nor the editors can guarantee the accuracy of the solutions offered. They also cannot ensure that the proposed answers will work in every situation.

Readers are encouraged to send in their comments regarding the published questions and answers.

Copyright ©2001 Medical Device & Diagnostic Industry


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