Declaration of Conformity to Design Control

S

Silvertabb

#1
Hi,
Assuming that the underlined text from FDA document shown below applies to my company, what is the impact
1) to filing new special 510k
2) to the Declaration of Conformity to Design Control






HOW TO PREPARE A SPECIAL 510 DOCUMENTmentions:

The declaration of conformity should include:
  1. A statement that, ...; and
  2. A statement that the manufacturing facility is in conformance with the design control procedure requirements as specified in 21 CFR 820.30 and the records are available for review. If a recent Quality System inspection has resulted in the issuance of a violative inspection report, the manufacturer should be prepared to describe those corrective actions taken, if needed, that form the basis for the declaration of conformity.
The above two statements should be signed by the designated individual(s) responsible for those particular activities.
 
Elsmar Forum Sponsor
G

George Weiss

#2
Hi,

I offer another thread for review:
This was covered in an earlier thread @
Elsmar Cove thread

Basic requirements @
http://www.emergogroup.com/sample-declaration-of-conformity


Regardless of the classification of your medical device, you must prepare an EU Declaration of Conformity (DOC) if you sell medical devices in Europe. The elements that should be included in the Declaration of Conformity include:
  • Name of the device, including model number and trade name.
  • Manufacturer name and address.
  • Name of company quality management representative.
  • Name and identification number (if applicable) of your Notified Body.
  • Name, address and telephone number of your European Authorized Representative.
  • Your CE Marking certificate number (if applicable).
  • Your conformity assessment route to compliance. List the Annex, classification and rule number (rule number only applies to the Medical Device Directive).
  • Standards that have been applied (optional)
  • Name and signature of a senior management representative and date signed.
The Medical Devices Directive makes some device class specific requirements. @
http://www.601help.com/Regulatory/mdd.html
For Class I, IIA, IIB, and III
.
EC Declaration of Conformity Template @
http://www.mdevices.net/eudecl.htm
 
Last edited by a moderator:
M

maxenix

#3
If the underlined text from FDA document shown applies to your company, when you prepare a new special 510k submission, you need describe those corrective actions taken, and this form the basis for the declaration of conformity, and it's nothing with "declaration of conformity" of your former submission.
 
S

Silvertabb

#4
maxinex,
...but the underlined text says that you should be prepared to addressed CAPA's if needed. To me it does not look like one has to include it in the submission. I realize FDA can come back and ask to explain your CAPA's.
 
M

maxenix

#5
Silvertabb,
IMO, it is the "Declaration of Conformity to Design Control "drafting requirements, so i think you need to describe those corrective actions taken plan in that documents to show that you comply with the QSR 820.30.

You can email FDA directly and ask for help.
 
S

singber

#6
We recently had a Special 510(k) submission (which cleared pretty quickly.) We included the signed declaration of conformity and a brief one page document explaining the steps we were taking to correct/prevent issues found during our last FDA inspection.
 
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