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COVID test related products

Requested from DOH by Edgardo Liu at 02:03 AM on Aug 05, 2020.
Purpose: Research Purposes
Date of Coverage: 01/01/2020 - 06/08/2020
Tracking no: #DOH-154692866258

Edgardo 02:03 AM, Aug 05, 2020

A blessed Day!

I would like to request a copy of the all product evaluation result done by RITM to all COVID -19 testing related products:
1.  PCR test kits
2. RNA Extraction kits
3. COVID-19 Rapid (Ag and Ab or Immunoassay Antibody test kits and reagents
4. Universal Transport Media or Virus Transport Media
5. Nasal and Oropharynx Swab

We are researching on the authenticity, sensitivity, and specificity of the products being use to the Filipino people.

FOI 08:07 AM, Aug 05, 2020

August 5, 2020

Dear Edgardo,

Thank you for your request dated Aug 05, 2020 under Executive Order No. 2 (s. 2016) on Freedom of Information in the Executive Branch, for COVID test related products.

We received your request on Aug 05, 2020 and will respond on or before Aug 26, 2020 02:03:42 AM, in accordance with the Executive Order's implementing rules and regulations.

Should you have any questions regarding your request, kindly contact me using the reply function on the eFOI portal at https://pcoomaster12152016140000-dot-efoi-ph.appspot.com/requests/aglzfmVmb2ktcGhyHQsSB0NvbnRlbnQiEERPSC0xNTQ2OTI4NjYyNTgM, for request with ticket number #DOH-154692866258.

Thank you.

Respectfully,

FOI Receiving Officer

Dr. Kenneth 08:49 AM, Aug 07, 2020

August 7, 2020

Dear Edgardo Liu,

I refer to my letter of Aug 05, 2020 02:03:42 AM about your request under Executive Order No. 2 (s. 2016) on Freedom of Information in the Executive Branch, for COVID test related products.

In order for us to work further on your request, we need more information from you regarding your query. Please be informed that the Food and Drug Administration is the agency that handles the evaluation and testing of COVID-19 test related products, not RITM. We suggest you visit the FDA website at https://www.fda.gov.ph/covid-19-fda-updates/ for COVID-19 updates.

Likewise, you may want to visit the list of FDA approved COVID-19 test kits at https://www.fda.gov.ph/fda-has-released-a-total-of-214-covid-19-test-kits-75-pcr-based-79-rapid-antibody-53-immunoassay-and-7-others/

Kindly advise and specify the purpose of your research? 

You may use the reply function on the eFOI portal at https://www.foi.gov.ph/requests/aglzfmVmb2ktcGhyHQsSB0NvbnRlbnQiEERPSC0xNTQ2OTI4NjYyNTgM, for request with ticket number #DOH-154692866258, to respond.

During the period of us awaiting your reply, your request will be put on hold. If we do not receive a reply on or before Oct 30, 2020 12:46:33 AM, your request will be closed.

We hope to hear from you at the soonest possible time.

Thank you.

Respectfully,
FOI Officer

Dr. Kenneth 07:59 AM, Aug 12, 2020

August 12, 2020

Dear Edgardo Liu,

Thank you for your response, with regard to my letter regarding clarifying your request on COVID test related products, dated Aug 07, 2020 08:49 AM.

We have now continued processing your request. We shall be referring your request to the Food and Drug Administration (FDA) for action.  Kindly give us until Aug 26, 2020 02:03 AM to respond regarding our findings.

Should you have any questions regarding your request, kindly contact me using the reply function on the eFOI portal at https://realinagencies11072018-dot-efoi-ph.appspot.com/requests/aglzfmVmb2ktcGhyHQsSB0NvbnRlbnQiEERPSC0xNTQ2OTI4NjYyNTgM, for request with ticket number #DOH-154692866258.

Thank you.

Respectfully,
FOI Officer

Dr. Kenneth 02:09 PM, Sep 03, 2020

September 3, 2020

Dear Edgardo Liu,

Greetings!

Thank you for your request dated Aug 05, 2020 02:03:42 AM under Executive Order No. 2 (s. 2016) on Freedom of Information in the Executive Branch.

Your Request

You asked for COVID test related products.

Response to Request

Your FOI request is approved. FDA does not require the usual process of registration for In Vitro Devices (IVDs) to be applied to COVID19 Test kits since we are in an emergency situation and we need to have immediate access to these test kits.  The FDA only issues special certification so that these test kits be allowed to be imported and used in our country.  In reference to your questions, please see attached guidelines issued in aid of implementation of the Bayanihan to Heal As One Act: 

1. FDA Memorandum No. 2020-006: Issuance of Special Certification for Imported Test Kits of COVID19
2 FDA Memorandum No. 2020-011: Performance Testing of Antibody Test kits with Issued Special Certification

FDA has also established appropriate mechanisms as part of post marketing surveillance of health products during this time of emergency. Given the novelty of this medical device, all steps must be in consideration of its new technology, varying specifications and continuous evolution as it aims to aid our health workers in the conduct of COVID19 testing. Guidelines are also issued to emphasize its proper use. Surveillance measures are in place to monitor the quality and effectiveness of this medical device. Issuances are also updated to address the urgency of the current situation. You can also check these FDA websites for COVID19 updates from our agency. 

https://www.fda.gov.ph/covid-19-fda-updates/  

We hope to have assisted you on the matter.  For more information and inquiries, kindly contact the FDA Center for Device Regulation, Radiation Health and Research through e-mail at cdrrhr@fda.gov.ph.

Your right to request a review

If you are unhappy with this response to your FOI request, you may ask us to carry out an internal review of the response by writing to Undersecretary Lilibeth C. David, Chair of Data Governance Oversight Committee/ DOH Central Appeals and Review Committee, at foi@doh.gov.ph. Your review request should explain why you are dissatisfied with this response, and should be made within 15 calendar days from the date when you received this letter. We will complete the review and tell you the result within 30 calendar days from the date when we receive your review request.

If you are not satisfied with the result of the review, you then have the right to appeal to the Office of the President under Administrative Order No. 22 (s. 2011).

Thank you.

Respectfully,
FOI Receiving Officer

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