The European Medicines Agency (EMA) has published the first of a series of guidance documents to help applicants prepare for the implementation of the Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR). The involvement of a Notified Body (NB) in a medicinal product with an integral medical device is the focus of the first EMA guidance related to the new European Union (EU) MDR. Read more “EMA publishes first series of EU MDR/IVDR guidance”
Category: Medical device
FDA delays enforcement dates for class I and unclassified device UDIs by two years
The Food and Drug Administration (FDA) has released new guidance which pushes back the date by which the FDA will enforce certain unique device identifier (UDI) requirements for class I and unclassified devices by two years. Read more “FDA delays enforcement dates for class I and unclassified device UDIs by two years”
European Commission releases guidance on UDIs
The European Commission has released five new guidance documents on the use of unique device identifiers (UDIs). The guidance covers UDIs for systems and procedure packs, definitions and descriptions of formats of the UDI core elements for systems and procedure packs, UDI assignment to medical device software, clarification of UDI responsibilities in relation to Article 16, and provisional considerations regarding language issues associated with the UDI database. Read more “European Commission releases guidance on UDIs”
FDA launches Special 510(k) Program Pilot
Following the release of draft guidance that proposed expanding the device changes that would be eligible for the special 510(k) program, the Food and Drug Administration (FDA) has launched a pilot to put the planned changes into use. Read more “FDA launches Special 510(k) Program Pilot”
FDA finalises guidance on benefit-risk factors for 510(k)s
The United States (US) Food and Drug Administration (FDA) has finalised guidance on evaluating the benefit-risk profile of medical devices submitted under the 510(k) pathway that have the same indication as their predicate devices but have different technological characteristics and benefit-risk profiles. Read more “FDA finalises guidance on benefit-risk factors for 510(k)s”
FDA proposes electronic submission for medical device market applicants
The US Food and Drug Administration (FDA) intends to remove requirements for paper and multiple copies of medical device premarket applications, and replace it with a single submission in electronic format. The new proposed rule would apply to: 510(k) premarket notifications; Investigational Device Exemptions (IDE); Premarket Approvals (PMA) applications and supplements; Humanitarian Device Exemptions (HDE) and applications to the Center for Biologics Evaluation and Research (CBER). Read more “FDA proposes electronic submission for medical device market applicants”
Health Canada launches pilot project on new meeting framework for pre-clinical advice on devices
Health Canada has launched a pilot project which aims to provide a new formal process for device companies seeking early advice. A formal pre-clinical process will allow manufacturers to discuss regulatory evidence requirements and investigational testing protocol design with Health Canada early in the device development process. The aim is to facilitate effective communication between medical device manufacturers and Health Canada to improve the quality of submissions and provide timely regulatory decisions. Read more “Health Canada launches pilot project on new meeting framework for pre-clinical advice on devices”
FDA release draft guidance on the uncertainty of medical device benefit-risk determinations
The US Food and Drug Administration (FDA) have released draft guidance regarding acceptable levels of uncertainty when it comes to the risk-benefit balance of medical devices.
FDA delays compliance date for UDI submissions for combination products
Manufacturers of combination products reviewed at the United States (US) Food and Drug Administration’s (FDA) Centre for Drug Evaluation and Research (CDER) have a received a year-long extension to comply with certain unique device (UDI) requirements. Read more “FDA delays compliance date for UDI submissions for combination products”
Draft guidance from FDA outlines pre-submission meeting options for medical device applicants
The United States (US) Food and Drug Administration (FDA) has updated guidance on how to utilise its Q-Submission program for medical device manufacturers before they submit premarket applications. The purpose of the draft guidance is to provide an overview of the mechanisms available to submitters through which they can request feedback from or request a meeting with the FDA prior to submitting premarket applications. Read more “Draft guidance from FDA outlines pre-submission meeting options for medical device applicants”