New FDA Draft Guidance Clarifies the Terms Device vs. Counterfeit Device It is apparent that there has been some problem with the FDA addressing devices as misbranded and/or adulterated when there was not a definition of a “counterfeit” device. So the FDA had to come up with a definition of a counterfeit device and is
As the COVID-19 variants surface and spread we are learning that testing methods may be affected and may in fact become ineffective. The FDA is in a race to keep up with the changes… SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests The SARS-CoV-2 virus has mutated over time, resulting in genetic variation in the population
FDA Proposes Changes to Agricultural Water Requirements in the Produce Safety Rule In an effort to address and eradicate potential contamination in regard to pre-harvest agricultural water the U.S. Food and Drug Administration published a proposed rule that would revise subpart E of the FDA Food Safety Modernization Act (FSMA) Produce Safety Rule to change certain pre-harvest
We want to keep everyone updated on the FDA EUA situation and for which devices they have discontinued the EUAs. We knew that the EUA was only temporary under the emergency COVID situation and now the FDA is starting to cut back on the EUAs as they have more supplies available to the marketplace via
We were always curious about how the FDA classified blood lancet devices as 510(k) exempt. Well, now the FDA has finally decided that blood lancets do require a 510(k). The FDA has four types of lancets, three are single patient and require a 510(k) and one intended for multiple use that would require a PMA.
Hearing Aid – OTC For those with mild to moderate hearing loss the day may be close when hearing aids are available over the counter… The FDA Issues Proposed Rule for Establishing Over-the-Counter Hearing Aids and Draft Guidance for Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products Hearing loss affects an estimated
Public Safety Alert: Stricter Guidelines Issued by the FDA for Alcohol-Based Hand Sanitizers Will Go Into Effect for 2022 – Pre-COVID Requirements Will Resume As we progress under the COVID rules that were put into effect as part of the EUA, the FDA is starting to rescind these EUAs as the supply shortages have been
PUBLIC BEWARE Warning from the FDA: Needle Free Devices for Certain Dermal Fillers Can Cause Permanent Harm to the Skin, Lips, or Eyes. The Safety or Efficacy of these Products Have Not Been Evaluated by the FDA! The U.S. Food and Drug Administration (FDA) is warning the public and health care professionals not to use
Cybersecurity Concerns Infiltrate the Medical Device Community – Risks Related to Medtronic Insulin Pumps Can Cause Serious Injuries or Even Death The FDA has been concerned about this type of attack and has required Cybersecurity in their 510(k) submissions. Here is an incident that has major implications for the device industry and resulted in a
It is that time of year, the annual drug registration renewal period opened through December 31, 2021. If you’re a DRUG company and want to keep your drug registration status current in 2022, FDA must receive notification that a firm’s drug registration and listing information 1) is certified as accurate and no changes have occurred since the previous update,
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