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)
There is no lack of codes. Current procedural terminology (CPT) codes are used primarily to identify medical and surgical procedures and services performed by physicians and other health care professionals. Codes for diagnosis related groups (DRGs) are a classification system developed by Medicare as part of the prospective payment system for inpatient care. There are
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?
On the 11th of May, the FDA announced the release of the final guidance for industry entitled: “Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management.” This was prepared under the support of the International Council for Harmonisation (ICH). ICH Q12, which was originally adopted as an ICH Guideline in November of 2019, establishes
The U.S. Food and Drug Administration has updated their discontinued medical devices list during the COVID-19 Public Health Emergency. The recently added items include gastroenterostomy tubes, gastrointestinal tubes, and accessories. Specific items recently added to the discontinuance list are manufactured by Bard Access Systems: 20F PULL Ponsky 20F PUSH Ponsky Bolus Feeding Tube Button Gastrostomy
The two “Rs” — regulatory and reimbursement — are critical elements of the environment in which a medical device product is developed. The design of innovative products in the highly regulated medical environment actually influence all stages of medical device development from the earliest stages of the development effort to its conclusion. Let’s first consider
Durisan Announces a Voluntary Recall Expansion of its Antimicrobial Hand Sanitizer With more and more companies trying to get into the hand sanitizer manufacturing business, companies need to understand that these products can become contaminated and need to be removed from the market. Here is a notice of voluntary recall expansion of a Non-Alcohol
By: Jeff Shuren, M.D., J.D., Director, Center for Devices and Radiological Health (CDRH) and Daniel Caños, Ph.D., M.P.H., Director, Office of Clinical Evidence and Analysis, Office of Product Evaluation and Quality, CDRH Among the many ways that the U.S. Food and Drug Administration protects and promotes the public health is by ensuring the safety and
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