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aids are available over the counter… The FDA Issues Proposed Rule for Establishing Over-the-Counter Hearing Aids and Draft Guidance for Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products Hearing loss affects an estimated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,
Recently, the FDA put out this update on the various government agencies (FDA/NIOSH/OSHA) and their responsibilities related to Covid 19. With all the confusion concerning respiratory and surgical masks we felt it was important enough to post it. COVID 19 has proven that we need to take respiratory protection very seriously. Whether it be in
Up until recently, the only way to market your SARS-CoV-2 tests was through an EUA application. EUA applications were implemented during the COVID crisis and were only a temporary and not a permanent way to market your device. For the SARS-CoV-2, there was no Substantial Equivalency and so a 510(k) was not an available option
FDA Cracking Down On Third Party Review Organization Accreditations of 510ks. Non-compliance Considered a Threat to Public Health and Safety… Over the years, since FDA had incorporated the third party review for the 510(k), mdi has periodically attempted to use third party review as requested by our clients to try to get a faster 510(k)
No Surprise – Effective October 1, 2021 FDA User Fees Will Increase These fees will be effective through September 30, 2022. Fortunately, the increases will not be too large for FY2022. The FDA annual registration fee for each establishment is $5,672 (in United States dollars) up from the $5546 of 2021. As previously, there are
The COVID 19 pandemic continues to change the way business is conducted and procedures are followed. Even government agencies such as the FDA has had to adapt their systems when travel restrictions have interfered. Will these alternate methods of conducting inspections cause a permanent shift and will quality assurance/control measures remain up to previous standards?
mdi Consultants, Inc