HIT Consultant
AUGUST 29, 2022
The medical device industry is booming and shows no signs of slowing down. In 2022, the FDA ( Federal Food and Drug Administration ) will clear or approve over 1,000 medical devices. Here’s a breakdown of some of the most anticipated otc medical devices that have already received FDA approval.
Health Law Advisor
JANUARY 3, 2023
The regulatory environment at the US Food and Drug Administration (“FDA”) has a tremendous impact on how companies operate, and consequently data on that environment can be quite useful in business planning. Product codes are the language of FDA regulation. Every medical device FDA regulates is placed into a product code.
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Exeed Regulatory Compliance
JULY 6, 2020
Let us understand how they help and how FDA plans to regulate them. In this article, we explain the FDA requirements, and guidance for face masks when they are used for a medical purpose such as diagnosis, or cure, mitigation, treatment of prevention of disease. We will cover the other types of medical PPE in another video.
Exeed Regulatory Compliance
JULY 10, 2020
The FDA is consistently updating its Guidance and policy for various Face Masks, Face Shields and Respirators as new information becomes available. We recently discussed the FDA’s policy for Face Masks during COVID-19. So, there are two parts to the definition of these devices – what they are and how they are used.
Exeed Regulatory Compliance
APRIL 2, 2020
Market for interconnected medical devices is projected to grow but the regulatory pathway is still evolving. A new FDA guidance offers helpful recommendations for design and premarket submission. Medical device industry is changing fast! You can think of many other examples in your daily life.
HIT Consultant
MARCH 28, 2024
Move from Innovation to FDA Submission in Just 90 Days The typical timeframe for engineering teams to move their orthopedic device innovations from market assessment and prototyping to documentation and submission is 12 months to two years. The industry-accepted average is 20 months.
HIT Consultant
MARCH 9, 2022
. – The XR50 , to be submitted for FDA clearance in the first half of the year, adds procedural guidance capabilities to the XR30 by creating a visible pathway for the practitioner’s instrument during procedures.
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