The Food and Drug Administration (FDA) has granted the Certificate of Medical Device Listing (CMDL) to OstreaVent II, a prototype mechanical ventilator, which was developed by the Department of Science and Technology (DOST)-Metals Industry Research and Development Center (MIRDC) in collaboration with Breath of Life Foundation.

DOST Secretary Fortunato “Boy” T. de la Peña announced this during his weekly report on Friday, March 19.

"The OstreaVent II was granted the Certificate of Medical Device Listing  (CMDL) by the Food and Drug Administration (FDA) after months of design,
prototyping, and a series of tests,” he said.

The CMDL refers to the authorization issued for a medical device that is intended for research, clinical trial, exhibit, donation, among others and that is not intended for sale. 

"Developed for adult use, the OstreaVentTM II prototype has undergone a series of performance and calibration tests by the Medical Equipment Healthcare Group, Inc. (MEDEQUIP) since August 2020,” de la Peña noted.

He said after several modifications and adjustments, the prototype was subjected to a 24-hour consistency test on March 8, 2021.

OstreaVent II was patterned after OstreaVent I, which is designed for infants, the DOST chief said.

"The issuance of the CMDL by the FDA is a much-awaited development for the OstreaVentTM II medical team who has already received a Certificate of Approval of its Safety Trial Protocol from the University of the Philippines Manila Research Ethics Board (UPMREB) in July 2020,” de la Peña said.

"The team can now proceed to the clinical trial phase.”