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03 Dec

FDA UPDATE: FDA Proposes Changes to Agricultural Water Requirements in the Produce Safety Rule

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

30 Nov

FDA UPDATE: An UPDATED EUA Discontinuance List

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

28 Oct

FDA Update: Hearing Aid – OTC

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aids are available over the counter… The FDA Issues Proposed Rule for Establishing Over-the-Counter Hearing Aids and Draft Guidance for Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products Hearing loss affects an estimated

FDA Reinstates OMUFA Facility Fees as of 2025
20 Oct

FDA UPDATE: Change in requirements for Alcohol based hand sanitizer manufacturers

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

11 Oct

FDA UPDATE: Cybersecurity Concerns Infiltrate the Medical Device Community

October 11, 2021 - 12:00 am
FDA Updates
By

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

07 Oct

FDA UPDATE: Now is the Time for the Annual FDA Drug Registration Renewal

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,

20 Sep

FDA update: COVID – 19 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

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