MedMira Inc V.MIR

Alternate Symbol(s): MMIRF

Technology Scientific & Technical Instruments

MedMira Inc. is a Canada-based developer and manufacturer of Rapid Vertical Flow (RVF) diagnostics. The Company's tests provide hospitals, labs, clinics and individuals with instant disease diagnosis, such as human immunodeficiency virus (HIV), syphilis, hepatitis, and SARS-CoV-2, in three steps. The Company is engaged in the business of research, development and manufacturing of rapid diagnostics and technologies. Its research is focused on specific areas of the broader diagnostics market, namely the rapid, point-of-care, and in vitro sectors. Its tests are sold globally under the REVEAL, REVEALCOVID-19, Multiplo and Miriad brands. Based on its patented Rapid Vertical Flow Technology, the Company's rapid HIV test has regulatory approvals in Canada, the United States, China and the European Union. Its manufacturing facilities are located in Halifax, Nova Scotia, Canada. It provides access to its RVF Technology for researchers, developers, and biotech companies on a license basis.

TSXV:MIR - Post by User

MedMira Inc

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Post by stealth21on Feb 07, 2013 9:54am

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Post# 20951445

info on the fda sight pre ide

Pre-IDE Submissions

In addition to telephone contacts and informal or formal guidance meetings, sponsors may submit preliminary information as a "pre-IDE" submission. Sponsors are encouraged to submit pre-IDE submissions while the sponsor is preparing the formal IDE submission whenever the sponsor requires informal FDA guidance on troublesome parts of the IDE application, e.g., clinical protocol design, pre-clinical testing proposal, pre-clinical test results, protocols for foreign studies when the studies will be used to support future marketing applications to be submitted to FDA.

Upon completion of the review of the pre-IDE submission, the reviewing division will issue a response to the sponsor in a timely manner, usually within 60 days of receipt. The response may take the form of a letter or comments provided during a meeting or telephone conference call. If FDA's response is provided via comments during a meeting or a telephone conference call, a memo of the meeting or conference call will be prepared.

A pre-IDE submission must be clearly identified as such, submitted in duplicate, and addressed to:

U.S. Food and Drug Administration
Center for Devices and Radiological Health
Document Mail Center – WO66-G609
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002