When you are asked: “Why should I use your medical device when the device I’m using now results in patient outcomes which seem to be adequate”, your answer should be a convincing value story (aka value proposition). A VALUE STORY is a clear and concise statement which demonstrates the clinical and economic benefits of using your
Upcoming Changes to GUDID Grace Period! The FDA has announced that it plans to make changes to the GUDID grace period to return to the original seven day grace period. These changes are scheduled to be released beginning in March 2019. According to the original GUDID Guidance released, the GUDID Device Identifier (DI) record grace
Nonbinding Feedback After Certain FDA Inspections of Device Establishments. When a company is issued a FDA-483 List of Observations, at the close of an inspection of their operations, the consequences of not implementing a timely and most importantly, proper corrections can put the company in a precarious situation. If FDA is not satisfied with how
FDA Issues Final Guidance: Immunogenicity Testing of Therapeutic Protein Products Last week, the FDA released a final guidance document entitled, “Immunogenicity Testing of Therapeutic Protein Products – Developing and Validating Assays for Anti-Drug Antibody Detection”. This final guidance is based on a draft guidance issued in April 2016 and the comments received during the industry
FDA OPERATIONS IN THE MIDST OF US GOVERNMENT SHUTDOWN. With the US Government shutdown-showdown continuing into its 3rd week, we took a closer look at the operations of Food and Drug Administration (FDA) during this period. According to a statement posted on the FDA website, agency operations continue to the extent permitted by law such
If you don’t plan where you are going, you’ll never get there. Once you have conducted a comprehensive reimbursement landscape assessment from the beginning and not before launch, it is critical to develop a reimbursement roadmap. This document is a visual, month-by-month plan for action for both the financial and operational aspects of the business
Possible Major Changes to 510(k) Program A 510(k) premarket submission is the most commonly used pathway to obtain an FDA market clearance for new medical devices. The essence of the 510(k) process is a demonstration of substantial equivalence (that is a device to be marketed is at least as safe and effective as a legally marketed
Environmental scanning of the reimbursement landscape, also known as reimbursement assessment, is a process that collects information on trends and priorities that impact or influence your medical device’s success in the marketplace. Performing an initial reimbursement assessment is important because it provides a baseline analysis of potential reimbursement gaps, risks, and opportunities for new medical
REMINDER: Annual Blanket No Changes Certification of DRUG Product Listing This is a reminder regarding the FDA’s recent drug certification requirements. Under the FDA’s new drug certification requirements, products that were not initially listed or updated during 2018 must be certified that their previously submitted drug listing information has not been changed. The product listing certification
The FDA has issued a total of 24 warning letters to the medical device industry for the fiscal year 2018. That is two WLs per month. WOW, that is AMAZING. With hundreds of inspections being conducted by the FDA, worldwide, such low number of warning letters would make one believe that the MEDICAL DEVICE industry
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