I think I know the answer but want to double check. A portion of the FDA
marking requirements is attached below. It indicates that month and year are
clearly marked. We wish to include week as well as those two items for our own
tracking purposes. I don’t think the rule prevents us from additional
marking it is simply indicating the minimum marking and if we chose to add the
week along with the required items we are in compliance, correct?

 

(ii) The month and year of manufacture shall be provided clearly and legibly,
without abbreviation, and with the year shown as a four-digit number as
follows:

MANUFACTURED: (INSERT MONTH AND YEAR OF MANUFACTURE.)

(b) In the case of products for which it is not feasible to affix
identification labeling in accordance with paragraph (a) of this section, upon
application by the manufacturer, the Director, Center for Devices and
Radiological Health may approve an alternate means by which such
identification may be provided.

(c) Every manufacturer of an electronic product to which a standard under this
subchapter is applicable shall provide to the Director, Center for Devices and
Radiological Health a list identifying each brand name which is applied to the
product together with the full name and address of the individual or company
for whom each product so branded is manufactured.

[40 FR 32257, July 31, 1975, as amended at 42 FR 18063, Apr. 5, 1977; 53 FR
11254, Apr. 6, 1988]

 

 

 

Gary McInturff

Reliability/Compliance Engineer

Advanced Input Systems

Esterline Corporation

600 West Wilbur Avenue

Coeur d' Alene, Idaho 83815

Tel: 208 635 8306

Fax 208 635 8706

 

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