510(k) Draft Guidance issued: 2011 vs 2014 - Appendix C. 510(k) Process diagram gone

R

rdawson_01

Does anyone have any insight as to why Appendix C. 510(k) Process diagram was taken out of the most recent Draft Guidance that was issued on July 28, 2014? In the Draft Guidance that was issued on July 28, 2014, Appendix C. is Sample of 510(k) Summary Complying with 21CFR 807.92.
 

Attachments

  • FDA Guidance 28Jul2014 - The 510K Program- Evaluating Substantial Equivalence in 510k Submission.pdf
    592.7 KB · Views: 179
  • FDA DRAFT Guidance - The 510K Program.pdf
    356.6 KB · Views: 181
M

MIREGMGR

Re: 510(k) Draft Guidance issued: 2011 vs 2014 - Appendix C. 510(k) Process diagram g

Appendix C was provided to help the user determine whether a Traditional, Special or Abbreviated was the appropriate path. FDA determined after the Draft Guidance was prepared that guidance on Specials and Abbreviateds would be removed, presumably to later be put into (probably) two separate additional Guidances, therefore Appendix C no longer fit the Traditional-only purpose of the Guidance we're presently discussing.
 
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