mdi Consultants, Inc
22
Jul
11
Aug
FDA User Fees for FY 2024 – Medical devices
Yes, the FDA has come out with the new FDA user fees for 2024. And as you can imagine the FDA is raising all fees from the annual registration to the 510(k)s. Annual Establishment Registration Fee for the coming year will be: $7,653 (talk about inflation – that is a 17% increase in the annual
02
May
The FDA Continues to Streamline their Process As They Announce Minor Updates to Refuse to Accept Policy for 510(k)s
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.
22
Nov
FDA update: FDA Issues Final Orders to Reclassify Blood Lancet Devices as Class II and Class III Devices and to Require PMAs for the Class III Blood Lancets
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.
11
Oct
FDA UPDATE: Cybersecurity Concerns Infiltrate the Medical Device Community
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
23
Aug
FDA Update: Third Party Reviews – FDA Cancels Certification
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)
12
Aug
FDA UPDATE: 2022 FDA USER FEES ANNOUNCED
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
25
Jan
New devices added to the device discontinuance list.
FDA Update New devices added to the device discontinuance list. The FDA is constantly reviewing their emergency use list. As we have been writing and warning that as the amount of needed products come to market via the EUA and 510(k) the FDA will discontinue the items. Companies should be away that they will need
26
Jun
FDA Update – Guidance on Formal Meetings and User Fee Applications
COVID-19 – Guidance on Formal Meetings and User Fee Applications Due to the COVID-19 public health emergency, the FDA has released a new guidance document titled “Effects of the COIVD-19 Public Health Emergency on Formal Meetings and User Fee Applications for Medical Devices – Questions and Answers.” The reason for this guidance is to address
02
Aug
FDA Update August 1, 2019
FDA announces the MDUFA fees for FY 2020. The FDA announced its fee rates and payments procedures for medical device user fees for the FY 2020. Fee rates for FY 2020 were adjusted for inflation. The fee rates go into effect from October 1, 2019 to September 30, 2020.The application fee should be paid for