[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR801.128]

[Page 26-27]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 801_LABELING--Table of Contents
 
          Subpart D_Exemptions From Adequate Directions for Use
 
Sec. 801.128  Exceptions or alternatives to labeling requirements for 
medical devices held by the Strategic National Stockpile.

    (a) The appropriate FDA Center Director may grant an exception or 
alternative to any provision listed in paragraph (f) of this section and 
not explicitly required by statute, for specified lots, batches, or 
other units of a medical device, if the Center Director determines that 
compliance with such labeling requirement could adversely affect the 
safety, effectiveness, or availability of such devices that are or will 
be included in the Strategic National Stockpile.
    (b)(1)(i) A Strategic National Stockpile official or any entity that 
manufactures (including labeling, packing, relabeling, or repackaging), 
distributes, or stores devices that are or will be included in the 
Strategic National Stockpile may submit, with written concurrence from a 
Strategic National Stockpile official, a written request for an 
exception or alternative described in paragraph (a) of this section to 
the Center Director.
    (ii) The Center Director may grant an exception or alternative 
described in paragraph (a) of this section on his or her own initiative.
    (2) A written request for an exception or alternative described in 
paragraph (a) of this section must:
    (i) Identify the specified lots, batches, or other units of the 
medical device that would be subject to the exception or alternative;
    (ii) Identify the labeling provision(s) listed in paragraph (f) of 
this section

[[Page 27]]

that are the subject of the exception or alternative request;
    (iii) Explain why compliance with the labeling provision(s) could 
adversely affect the safety, effectiveness, or availability of the 
specified lots, batches, or other units of a medical device that are or 
will be held in the Strategic National Stockpile;
    (iv) Describe any proposed safeguards or conditions that will be 
implemented so that the labeling of the device includes appropriate 
information necessary for the safe and effective use of the device, 
given the anticipated circumstances of use of the device;
    (v) Provide a draft of the proposed labeling of the specified lots, 
batches, or other units of the medical device subject to the exception 
or alternative; and
    (vi) Provide any other information requested by the Center Director 
in support of the request.
    (c) The Center Director must respond in writing to all requests 
under this section. The Center Director may impose appropriate 
conditions when granting such an exception or alternative under this 
section.
    (d) A grant of an exception or alternative under this section will 
include any safeguards or conditions deemed appropriate by the Center 
Director so that the labeling of devices subject to the exception or 
alternative includes the information necessary for the safe and 
effective use of the device, given the anticipated circumstances of use.
    (e) If the Center Director grants a request for an exception or 
alternative to the labeling requirements under this section:
    (1) The Center Director may determine that the submission and grant 
of a written request under this section satisfies the provisions 
relating to premarket notification submissions under Sec. 807.81(a)(3) 
of this chapter.
    (2)(i) For a Premarket Approval Application (PMA)-approved device, 
the submission and grant of a written request under this section 
satisfies the provisions relating to submission of PMA supplements under 
Sec. 814.39 of this chapter; however,
    (ii) The grant of the request must be identified in a periodic 
report under Sec. 814.84 of this chapter.
    (f) The Center Director may grant an exception or alternative under 
this section to the following provisions of this chapter, to the extent 
that the requirements in these provisions are not explicitly required by 
statute:
    (1) Sec. 801.1(d);
    (2) Sec. 801.60;
    (3) Sec. 801.61;
    (4) Sec. 801.62;
    (5) Sec. 801.63;
    (6) Sec. 801.109; and
    (7) Part 801, subpart H.

[72 FR 73601, Dec. 28, 2007]