Angels, venture capitalists and strategic partners don’t want to commit financial resources to help a manufacturer develop a new medical device if they feel they will not get adequate return on investment in a reasonable timeframe. That makes perfectly good sense. Such a manufacturer must first perform a preliminary analysis as to whether their medical
Could this be the start of the FDA rescinding the EUAs? On October 15, 2020, the FDA reissued the EUA for certain filtering face-piece respirators (FFRs) manufactured in China which are not approved by the CDC’s National Institute for Occupational Safety and Health (NIOSH). The agency is reissuing this EUA to authorize only those types
This is very important information for foreign companies where we have observed many companies trying to get an edge by saying such terms as “FDA approved”, or “FDA CERTIFIED”. Make sure you read this. The FDA logo is made up of two components, the Monogram and Wordmark. The combination of the two components is what
FDA Update – October 19, 2020 FDA establishes U.S. Agent Voluntary Identification System for Food Facilities The FDA is issuing a new guidance document, U.S. Agent Voluntary Identification System (VIS) for Food Facility Registration. This is in conjunction with the FDA’s food facility registration database, the Food Facility Registration Module (FFRM). The purpose of the
For almost all medical devices associated with a medical or surgical procedure, there must be a corresponding CPT code. It’s simple – if there is no CPT code for those who perform the procedure to place on a billing claim to receive payment from insurers, providers will not use your medical device because they will
Food companies please note The 2020 Biennial Registration Renewal Period began October 1, 2020 and concludes on December 31, 2020. Section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. 350d] requires food facilities required to register with FDA to renew such registrations during the period beginning on October 1 and
On September 23, 2020, mdi Consultants successfully obtained EUA authorization for our client Jiangsu Well Biotech Co., Ltd.’s “Orawell IgM/IgG Rapid Test”. This is only the 16th rapid antibody test authorized by the FDA to identify the presence of both IgG and IgM antibodies since the EUA period began in March, 2020. Throughout the FDA review
mdi predicated that the FDA would be closing these EUA down as soon as there are enough supply on the market. (https://mdiconsultants.com/life-after-the-eua/) The FDA monitors the 510(k) activity as we as the importing supply. The FDA has also been contacting companies to determine the amount of supply of various devices. This is the history of
The FDA has recently been made aware of potential adverse health effects of mercury exposure with the use of dental amalgam to certain groups. This is due to the mercury vapor (gas) released from the dental amalgam fillings. These groups include: Pregnant women and their developing fetuses; Women who are planning to become pregnant; Nursing
Tuesday, September 15th, 2020, the FDA published comparative performance data for some authorized COVID-19 molecular diagnostic tests. The tables show the Limit of Detection (LoD) of more than 55 authorized molecular diagnostic COVID-19 tests against a standardized sample panel provided by the FDA. The FDA provided these standardized samples, known as a reference panel, to
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