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  文章标题:《2004年10月1日起FDA政策的变更(电子产品不包括医疗类产品)》
  发表日期:2004年12月7日        已经有403位读者读过此文


We are requesting manufacturers and importers not telephone, fax, or email requests for accession numbers or acknowledgement letters for at least 30 days after a Product Report, Annual Report, Quality Control Aspect Report, or Supplemental Report has been submitted to the Center for Devices and Radiological Health.

 

The purpose of this policy is to allow our existing document control process to work – acknowledgement letters and accession numbers should be received within 30 days of submitting the report.  Unfortunately, we cannot respond on-demand to each request for an acknowledgement letter and accession number, due to limited available resources and higher priority work.  If feedback from CDRH is not received within 30 days of report submission, the delay indicates either a potential problem with transmittal of the report or with our document control process.  Once 30 days have passed from the time of report submission, we will assist manufacturers who have not received an acknowledgment letter or accession number.

 

Also note that requests for acknowledgement letters or accession numbers by consultants should be directed first to the manufacturer of the product described in the report.  CDRH sends acknowledgement letters only to the individual identified by the manufacturer as its corresponding official:  most commonly the submitter of the report or the importing agent.

 

We are also asking that manufacturers refrain from submitting reports by fax or electronic mail, including those reports addressing addition of new models.

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