American Clinical Laboratory Association - Citizen Petition

This Other document was issued by the Food and Drug Administration (FDA)

For related information, Open Docket Folder


Content

See attached file(s)

Attachments

 (19)

American Clinical Laboratory Association Citizen Petition

View Attachment:
Authors: cdrh
 

Exhibit 1 LexisNexis FDC Reports Inc The Gray Street

Reason Restricted: This attachment is restricted to show metadata only because it contains copyrighted data.
 

Exhibit 2 LexisNexis The Gray Street 50 of 81 Document

Abstract: Unwilling to Regulate Homebrews FDA Inches forward on ASRS Microarrays
Reason Restricted: This attachment is restricted to show metadata only because it contains copyrighted data.
 

Exhibit 3 Turna Ray FDA Shelves IVDMIA Final Guidelines in Order to Focus on Overall LDT Regulation

View Attachment:

Exhibit 4 Oxford Dictionary

Reason Restricted: This attachment is restricted to show metadata only because it contains copyrighted data.
 

Exhibit 5 Medical Device Amendments of 1976 Conference Report 94th Congress House of Representatives Report 94 1090

View Attachment:

Exhibit 6 Medical Device Amendments of 1976 Report 94th Congress House of Representatives Report 94 853

View Attachment:

Exhibit 7 Medical Device Amendments Report 1975 94th Congress Senate Report 94 33

View Attachment:

Exhibit 8 Congressional Record Senate

View Attachment:

Exhibit 9 Food Drugs and Cosmetics Hearing before Subcommittee of the Committee on Interstate and Foreign Commerce 74th Congress

View Attachment:

Exhibit 10 Congressional Record House

View Attachment:

Exhibit 11 House of Representatives Clinical Laboratory Improvement Amendments of 1988

View Attachment:

Exhibit 12 Deadly Mistakes Are Laboratory Results Reliable Hearings before Subcommittee on Regulation and Business Opportunities...

View Attachment:

Exhibit 13 Medical Testing Improvement Act of 1988 100th Congress Senate Report 100 561

View Attachment:

Exhibit 14 Congressional Record House

View Attachment:

Exhibit 15 Turna Ray Qiagen Enters Companion Dx Market With Approval of KRAS Test Kit for Erbitux

View Attachment:

Exhibit 16 Nowak and Kaul The Role of Community Molecular Diagnostics Laboratories in the H1N1 Pandemic

Reason Restricted: This attachment is restricted to show metadata only because it contains copyrighted data.
 

Exhibit 17 Comments from Eli Lilly Co to CMS

View Attachment:

Exhibit 18 Report of the Secretary US System of Oversight of Genetic Testing A Response to the Charge of the Secretary of Health...

View Attachment:

 
 
ID: FDA-2013-P-0667-0001

Document Information

Date Posted: Jun 17, 2013
Show More Details  

Submitter Information

Country: United States
Category: Private Industry - C0003

Comments

5
Comments Received*
On Behalf of the Combination Products Coalition ("CPC") and the CPC Personalized Medicine Working Group, please find attached our comments on the American...
Quest Diagnostics Incorporated submits the attached document in support of the Citizen Petition filed by the American Clinical Laboratory Association regarding...
Dear Sir or Madam: I wish to submit comments in support of the American Clinical Laboratory Association’s (ACLA) citizen petition (Docket No. FDA-2013-P-0667...

* This count refers to the total comment/submissions received on this document, as of 11:59 PM yesterday. Note: Agencies review all submissions, however some agencies may choose to redact, or withhold, certain submissions (or portions thereof) such as those containing private or proprietary information, inappropriate language, or duplicate/near duplicate examples of a mass-mail campaign. This can result in discrepancies between this count and those displayed when conducting searches on the Public Submission document type. For specific information about an agency’s public submission policy, refer to its website or the Federal Register document.