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
Health Canada Adjusts Medical Device Single Audit Program (MDSAP) Transition 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
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
UPDATE: NDC/NHRIC Labeler Codes for Medical Devices!! We have been recently getting a lot of queries regarding whether or not FDA can still issue NDC/NHRIC labeler codes for medical devices with the recent advent of the new UDI (Unique Device Identification) regulations being implemented by the FDA. The answer to this question is NO!!! Some
Process Validation and Additive Manufacturing (AM) -Validate your 3D Printing for Compliance and Business Success Medical device makers are enthusiastic about 3D printing. They are not alone. As 3D printing (or additive manufacturing, AM for short) goes from niche to commonplace, players are determined for sales in this lucrative market. This manufacturing sector is expected
Deciding When to Submit a 510(k) for a Change to an Existing Device?? Earlier this week, the FDA issued a new guidance regarding deciding when to submit a 510(k) for a change to an existing device which superseded the original guidance document released in 1997. The new guidance has taken the original content and
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