At the MedTech Forum 2022 in Barcelona, there was a tense and “standing room only” moderated session on the looming May 26, 2024 EU Medical Device Regulations (MDR) implementation deadline. Representatives from the notified bodies, competent authorities, industry, and other trade groups had a very intense interchange about the deadline, which requires all companies selling […]
In a previous blog post (here), we discussed the results of an April 16, 2021 decision by the U.S. Court of Appeals for the District of Columbia Circuit in Genus Med. Techs., LLC v. FDA, 2021 (U.S. App. Lexis 10928 [April 16, 2021]) which the FDA decided not to appeal. This court decision dealt with […]
The US Food and Drug Administration published their much-anticipated proposed rule (PR) to amend the Quality System Regulation (QSR) (21 CFR Part 820) on February 23, 2022. After four years in the works and much debate about what the PR would include, we can finally read it for ourselves. The question in my mind was […]
In the prepublication edition of the Federal Register, the proposed rule on revisions to the Quality System Regulation was published today and may be found here. According to the notice, the Agency “is proposing to amend the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) Regulation to align more closely with […]
Tomorrow, FDA will issue a revised draft guidance on Hearing Aids and Personal Sound Amplification Products (PSAP) (here), and is also publishing a proposed rule for the over the counter (OTC) classification of hearing aids (HA) and PSAP (here) entitled “Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the-Counter Hearing Aids”. These are the prepublication […]
Just nine (9) days ago, I posted a blog and article (here) on the issue of paper prescribing information – package inserts! The overall takeaway was that FDA is ready to move on this issue. There was a proposed rule sitting dormant, because every year since its proposal, e Congress has included a provision in […]
Ricki A. Chase, M.S, Lachman Consultants, wrote a recent article for Contract Pharma looking at the benefits and challenges of the trend towards combination products. Here is a brief excerpt from the article: “As the life sciences industries have continued to evolve, the need for ever changing nomenclature has evolved along with it. It was […]
The week of February 1, 2021, Lachman Consultants held their inaugural Medical Device Week: A Lachman Learning Experience™. The week combined blogs and a webinar that touched on several different topics involving AI and diagnostics, data governance, SDLC infrastructure, change control, cybersecurity, as well as organizational maturity. Despite the name of the week, many of […]
Interoperability in healthcare has been discussed for decades and is one the greatest challenges to be overcome in medicine. Not only because technical barriers exist, but because physicians practice medicine and research continue to push the boundaries, creating new terms to be defined and understood. In addition, the rate of this is accelerating (witness the […]
What engineer enjoys writing Software Development Life Cycle (SDLC) documents, such as a Software Requirements Specification or SFMEA? I have yet to meet one that has the passion to sit and document the requirements. While there are numerous purposes and reasons for documenting the requirements, the greatest value is in the process that leads up […]
