A 510(k) is an FDA premarket submission demonstrating a new medical device is “substantially equivalent” (safe and effective) to a legally marketed predicate device. Primarily for Class II and some Class I/III devices, it requires providing performance data to prove similarity in safety, effectiveness, and intended use.
A 510(k) marketplace is an informal term used to describe a process where companies buy, sell, license, or transfer rights to an existing FDA 510(k) clearance for a medical device.
In simple terms, instead of going through the entire FDA submission process from scratch, a company may acquire a device that already has 510(k) clearance and bring it to market under its own ownership or branding.
510(k)s for Medical Devices are like other Intellectual property bought and sold and then transferred to other companies.
A typical 510(k) marketplace transaction may involve:
This is a process mdi Consultants have assisted companies on for about 40 years.
If you have a company that has 510(k)s and are not using them any longer, or never marketed the device and would like to see if there is a company that would like to purchase your 510(k), here is a marketplace where you can post it.
We will review your 510(k), determine the year and documents you have associated with the 510(k) and work out a price range for the sale.
We will post the 510(k) on the site and assist with the transfer of the 510(k) once a sale has been made.
FDA Update The FDA Continues to Streamline their Process As They Announce Minor Updates to Refuse to Accept Policy for 510(k)s – Final Guidance Helps to Clarify What Is Acceptable to the FDA On April 25, 2022 the U.S. Food and Drug Administration (FDA) updated the 2019 final guidance: Refuse to Accept Policy for 510(k)s.
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.
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
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
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