[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR808.5]

[Page 76-77]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 808--EXEMPTIONS FROM FEDERAL PREEMPTION OF STATE AND LOCAL MEDICAL DEVICE REQUIREMENTS--Table of Contents
 
                      Subpart A--General Provisions
 
Sec. 808.5  Advisory opinions.

    (a) Any State, political subdivision, or other interested person may 
request an advisory opinion from the Commissioner with respect to any 
general matter concerning preemption of State or local device 
requirements or with respect to whether the Food and Drug Administration 
regards particular State or local requirements, or proposed 
requirements, as preempted.
    (1) Such an advisory opinion may be requested and may be granted in 
accordance with Sec. 10.85 of this chapter.

[[Page 77]]

    (2) The Food and Drug Administration, in its discretion and after 
consultation with the State or political subdivision, may treat a 
request by a State or political subdivision for an advisory opinion as 
an application for exemption from preemption under Sec. 808.20.
    (b) The Commissioner may issue an advisory opinion relating to a 
State or local requirement on his own initiative when he makes one of 
the following determinations:
    (1) A requirement with respect to a device for which an application 
for exemption from preemption has been submitted under Sec. 808.20 is 
not preempted by section 521(a) of the act because it is: (i) Equal to 
or substantially identical to a requirement under the act applicable to 
the device, or (ii) is not a requirement within the meaning of section 
521 of the act and therefore is not preempted;
    (2) A proposed State or local requirement with respect to a device 
is not eligible for exemption from preemption because the State or local 
requirement has not been issued in final form. In such a case, the 
advisory opinion may indicate whether the proposed requirement would be 
preempted and, if it would be preempted, whether the Food and Drug 
Administration would propose to grant an exemption from preemption;
    (3) Issuance of such an advisory opinion is in the public interest.