Date: July 30, 2015
Dear Endoscope Device Sponsor:
This letter is to advise you of a correction to the July 27, 2015 letter you received regarding CDRH’s decision to retire product code KOG. Under the section “What You Should Do – Update Listing Information” we instructed you to update your listing in FURLS to reflect the new product code. This is incorrect. Once CDRH updates the premarket notification [510(k)] database with the new product code, this will automatically update the FURLS listing for the associated 510(k). We apologize for any confusion.
In addition, establishments located outside the U.S. should notify their shipping partners of the new product code.
If you have any questions about this notice or would like more general information about medical device regulations, please contact the Division of Industry and Consumer Education (DICE) by email at [email protected] or by phone at 1 (800) 638-2041
Sincerely yours,
Elias Mallis
Director
Division of Industry and Consumer Education
Office of Communication and Education
Center for Devices and Radiological Health
U.S. Food and Drug Administration
Original FDA message from July 27, 2015:
Dear Endoscope Device Sponsor:
This letter is to advise you that the Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) has updated the product codes used to classify endoscope devices and accessories under the regulation 21 Code of Federal Regulation (CFR) 876.1500 (Endoscope and accessories).
Background
CDRH analyzed all 510(k)s cleared under 21 CFR 876.1500, titled “Endoscope and Accessories” and found that the most common product code used to classify devices with this regulation was the product code KOG, titled “Endoscope and/or Accessories.” KOG was extensively used for a large variety of medical devices associated with endoscopes. Over the years, CDRH created new product codes under 21 CFR 876.1500 that were specific and intended to group similar subsets of devices within the same product code.
As a result of the analysis, CDRH decided to retire the product KOG and reassign all 510(k)s previously assigned to KOG to a more suitable, device-specific product code. Over 600 510(k)s are within the scope of this project.
What CDRH Will Do
CDRH will update the product code for the KOG product codes in this sequence:
1. CDRH will issue corrected substantial equivalence (SE) letters that were previously assigned the product code KOG. The corrected SE letters will be issued to the holders of the 510(k)s at the time of clearance (i.e., they will be sent to the address that appears on the original SE letter). Given the large number of 510(k)s involved, we anticipate this effort will take several weeks to complete.
2. Upon issuance of each 510(k)’s corrected SE letter, CDRH will update the 510(k) database to reflect this change. The updated product code will be put into effect after CDRH has issued the corrected SE letter that contains the updated product code. The regulatory status of the cleared devices is unchanged: all previously-cleared 510(k) devices remain legally marketed as a result of this product code update.
3. With the completion of this effort, KOG will not be available for use as a product code to classify new medical devices. Please do not attempt to cite this product code in future 510(k) submissions.
What You Should Do – Update Listing Information
After you receive your corrected SE letter, please then go into your account in the FURLS database system to update your listing with the new product code identified in your corrected SE letter.
Note to Current 510(k) Holders who are not Original 510(k) Holders
If you market an endoscopic device that was classified with the product code KOG and are not the original 510(k) holder, you will likely not receive the corrected SE letter because you are not the point of contact on record. If you would like to verify the status of this change and request a faxed copy of the corrected SE letter, please contact Marjorie Shulman, Director of the 510(k) Staff, via e-mail, at [email protected].
New Product Codes
All 510(k)s previously assigned to product code KOG will be reassigned to another product code. The most common product codes used in the reassignment are listed in the table below:
All of the above product codes are Class II, under 21 CFR 876.1500.
Effect of KOG Retirement on 2015 Reprocessing Medical Devices Guidance (Appendix E)
Appendix E in FDA’s final guidance titled “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling” lists devices and product codes for which a 510(k) should contain the data used to validate the recommended reprocessing instructions. Some of the corrected SE letters replace product code KOG with another product code listed in Appendix E. New 510(k) submissions for any device listed in Appendix E should include reprocessing validation data, even if the predicate device was originally cleared under the product code KOG.
KOG was listed in the Reprocessing Guidance under Automated Endoscope Reprocessors (AERs). Reprocessing devices previously assigned to KOG will be replaced with one of these product codes:
- FEB – Accessories, cleaning, for endoscopes; or
- NZA – Accessories, germicide, cleaning, for endoscopes.
Need Further Clarification
If you have any questions about this notice or would like more general information about medical device regulations, please contact the Division of Industry and Consumer Education (DICE) by email at [email protected] or by phone at 1 (800) 638-2041.
Sincerely yours,
Elias Mallis
Director
Division of Industry and Consumer Education
Office of Communication and Education
Center for Devices and Radiological Health
U.S. Food and Drug Administration
