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
HCPCS Codes Rather than writing out the name of the diagnosis, medical device or surgical procedure on a claim form for payment by insurers, standardized code sets have been established so that providers, suppliers, Medicare and private insurers can convey information in a simple and consistent manner, especially placed on a claim form for billing
FDA Innovation Challenge: Devices to Prevent and Treat Opioid Use Disorder! This is an interesting proposal for medical device industry from the President’s administration to help push an end to the opioid crisis. The FDA issued an innovation challenge to create devices to prevent opioid abuse and treat those who are already addicted. Applications will
FDA Finalizes 510(k) Exemptions for Certain Class II Devices On June 5th, 2018, the Federal Register for the FDA was updated to include exemptions for some class II medical devices. This update was a result of the Century Cures Act of 2016, which allows the FDA to under its own prerogative or through the petition
FDA issues a Notice May 23, 2018 Proposed Rule Making (NPRM): Harmonizing and Modernizing Regulation of Medical Device Quality Systems!! As a part of its Spring 2018 “Unified Agenda of Federal Regulatory and Deregulatory Actions” (Unified Agenda), FDA recently issued a Notice of Proposed Rule Making (NPRM) that states by Spring 2019 FDA will propose a
For many years, mdi Consultants has provided assistance in FDA regulatory approvals and compliance for a wide range of medical device companies. Now, mdi Consultants has decided to expand its services to include the development of strategies to help manufacturers obtain reimbursement for their new medical devices and/or their associated procedures after FDA approval. mdi
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