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
On Friday, April 13th, Health Canada released an update regarding their transition to the Medical Device Single Audit Program, also known as MDSAP. If you’re not familiar with or have not heard of the MDSAP as a new initiative yet, it is a new program that allows a company to conduct a single regulatory audit
Updated FDA Guidance regarding Medical Device Accessories and Classification Pathways!! The FDA has just released an updated final guidance entitled, “Medical Device Accessories – Describing Accessories and Classification Pathways”. This guidance was originally issued out to industry and FDA staff one year ago in December of 2016. This update focuses on explaining new mechanisms to
BEWARE – FDA Inspections in China with 5 day notice mdi recently received an email from one of our clients in China that read: “We just received a “notice” from the USA FDA via the US Embassy in Beijing that there will be an inspection this coming Monday. Is this normal to be contacted from
NEW GUIDANCE! Manufacturers Sharing Patient Specific Information from Medical Devices with Patients upon Request On October 30th, the FDA issued a new guidance detailing how manufacturers should share patient specific information from medical devices with patients upon request. In many cases, patients express an interest in obtaining information which is retrieved from a legally marketed medical
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