FDA Circular No. 2020-006B was released last July 17, 2020. This contains modified guidelines for submission and appearance at FDA office for compliance/meetings, regulatory, enforcement and quasi-judicial actions, and release of LTO and CPRs while the country is still on quarantine.
The following transactions are suspended until further notice:
- Suspension of face-to-face meetings, public consultations, hearings, and symposium. Online meetings/conferencing is encouraged for urgent matters.
- Resolution and execution of legal cases/actions and filing of complaints to the Legal Service Support Center will resume after lifting of the community quarantine. However, there is an exemption. That is if the case involves matters affecting the pandemic such as violations of COVID-19 related rules.
- Foreign inspections
- Request for scanned copies of LTO and CPRs will be no longer processed. The hard copies are available at the releasing section and if not picked-up within 10 working days, PFDA will mail the certificate to the registered company mailing address.
On the other hand, PFDA continues to monitor for non-compliant devices and health products and issues public advisories accordingly.
FDA Circular No. 2020-006B