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
No matter how hard it is to manufacture a safe and efficacious medical device, it is not going to generate the anticipated revenues unless it can be properly reimbursed by insurers. While considerable time, effort and expense are required to successfully carry out a reimbursement strategy, such a plan is essential to assuring a favorable
Common Mistakes Medical Device Manufacturers Make Today’s economic healthcare environment has created overwhelming reimbursement challenges. The situation is frequently complex and the stakes are high. Companies need not wait for FDA approval before addressing reimbursement issues which they should begin early in the medical device’s development. Putting reimbursement on the back burner until after launch
FDA Food Facility Registration Renewal Period!! Next week, on October 1, 2018, the FDA’s Biennial Registration Renewal Period begins for 2018. Food facilities are required to register with the FDA and renew their registrations between October 1 and December 31 every year as specified under section 415 of the FD&C Act. Food facilities that were
Quality in 510(k) “Quik” Review Program Pilot. On September 6th, the FDA launched the Quality in 510(k) “Quick” Review Program pilot. This program is expected to help manufacturers simplify the premarket notification submission process for certain moderate-risk medical devices. The pilot will also evaluate whether the FDA’s eSubmitter software will result in more organized submissions,
Medical Devices; Classification of Accessories Distinct from Other Devices; Proposed List of Accessories Suitable for Class I; Request for Comments. As required by the FDA Reauthorization Act of 2017 (FDARA), the FDA has identified a list of accessories for which the Agency believes general controls alone are sufficient to provide reasonable assurance of safety and
EU Approves New In-Vitro Diagnostic Device Regulation; Transition period has begun. On April 5, 2017, the European Parliament approved the new In-Vitro Diagnostic Device Regulation. This is the first major change in the IVD regulations. There is a five-year transition period following the formal publication of the IVDR for the industry to become compliant with
Until recently, medical decisions were highly subjective, being called “clinical judgment”, “the art of medicine” or “in my experience”. To gain knowledge, practitioners got their information from reading textbooks whose information is over 3 years old and a few journal articles. To keep up to date, reading the vast amount of journal articles published in
CPT Codes Current Procedural Terminology (CPT) codes are a proprietary 5-digit numeric coding system that is owned, managed, and maintained by the American Medical Association (AMA). They are used to describe office visits and medical and surgical procedures performed by physicians and other health care professionals. Decisions regarding the application for a new CPT code
Logical Observation Identifiers Names and Codes for In Vitro Diagnostic Tests. On June 15th, 2018 the FDA released a guidance attempt to standardize the way that in vitro diagnostic (IVD) tests are coded. This standardization was mainly created to assist the implementation of electronic health records (EHR) for the IVD tests. Laboratories commonly use a
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