As prescribed in 11.204-92 insert the following provision:
PRE-MARKET NOTIFICATION (APR 2008 MEDICAL) - DLAD
All offerors must be in compliance with Section 510(k) of the Federal Food, Drug and Cosmetic Act for those medical device products intended to be delivered to the Government. In accordance with 21 CFR Part 807 Subpart E, approval is required 90 days prior to either the submission of the initial offer (date the bid/proposal is signed) or the original opening/closing date (whichever comes first). Offerors are required to be in compliance by listing below the item number, corresponding premarket notification number and date of Food and Drug Administration (FDA) approval or the specific basis for exemption from the notification procedures as delineated in 21 CFR Part 807 Subpart E. The Government will rely on the offeror’s information for evaluation and award purposes. Offerors not in compliance 90 days prior to either the submission of the initial offer (date the bid/proposal is signed) or the original opening/closing date (whichever comes first), OR not providing the information below, will be determined technically unacceptable (nonresponsive if an IFB) and the offer will be rejected. Offerors that are determined ineligible will not be allowed to submit evidence of compliance at a later date. False information will be grounds for terminating any contract(s) resulting from this solicitation.
Item Number Premarket Notification Number/Approval Date
OR
State Basis for Exemption
I (name of authorized representative), ______________________________________, hereby state that to the best of my knowledge and belief the information provided here is complete and accurate.
___________________________
Authorized Representative’s Signature
_________________________________
Authorized Representative’s Title
__________________________
Date
(End of Provision)
