ANVISA, the National Health Surveillance Agency in Brazil, has announced that it will accept confidential information on inspections received under agreements or covenants with health authorities of other countries1. The granting of Good Manufacturing Practice certification may now occur upon…
On 17 April 2018, the Food and Drug Administration released its Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health1. This new Action Plan sets out the Agency’s vision for how it can continue to enhance its programmes and…
Comments are being accepted until 11 July 2018 on draft guidance entitled, Expansion of the Abbreviated 510(k) Program: Demonstrating Substantial Equivalence Through Performance Criteria; Draft Guidance for Industry and Food and Drug Administration Staff1,2. This draft guidance document proposes an…
The Food and Drug Administration (FDA) has finalised two guidance documents that provide recommendations for designing, developing and validating tests that use next generation sequencing (NGS) to scan a person’s deoxyribonucleic acid (DNA) to diagnose genetic diseases, which are usually…
New guidance has been released entitled, Policy Clarification and Premarket Notification [510(k)] Submissions for Ultrasonic Diathermy Devices; Guidance for Industry and Food and Drug Administration Staff1,2. This guidance clarifies the Food and Drug Administration’s (FDA’s) policy on compliance with applicable…
An updated version of the Refuse to Accept Policy for 510(k)s: Guidance for Industry and Food and Drug Administration Staff was issued on 30 January 20181. This document superseded the policy of the same name dated 4 August 2015. The…
An updated version of the Acceptance and Filing Reviews for Premarket Approval Applications (PMAs): Guidance for Industry and Food and Drug Administration Staff has been published1. This document supersedes the guidance of the same name dated 31 December 2012. The…
A new guidance for industry has been published1,2 to explain the structured process for a Pre-Request for Designation (Pre-RFD) from the Office of Combination Products (OCP). The guidance describes (and helps a sponsor understand) the type of information that should…
An immediately-in-effect guidance for industry has been published entitled Compliance Policy for Combination Product Postmarketing Safety Reporting1,2. This guidance outlines the Food and Drug Administration’s (FDA’s) compliance policy for Combination Product Applicants and Constituent Part Applicants and activities under Title…
The Food and Drug Administration has made a number of non-substantive changes1 to the regulations contained in Title 21 of the Code of Federal Regulations Parts 890 (Physical Medicine Devices), 900 (Mammography), 1020 (Performance Standards for Ionizing Radiation Emitting Products)…
A final order has been published exempting Class II over-the-counter (OTC) denture repair kits (product code EBO) from the pre-market notification (510(k)) requirements1. These devices consist of material such as a resin monomer system of powder and liquid glues that…
A final rule1 has been published that delays indefinitely the effective date of certain portions of a final rule published in the Federal Register on 9 January 2017 concerning when products made or derived from tobacco are regulated as drugs,…
A final rule on the acceptance of data from clinical investigations for medical devices has been published with an effective date of 21 February 20191. The rule updates the Food and Drug Administration’s (FDA’s) standards for accepting clinical data from…
The extracorporeal shock wave device for treatment of chronic wounds has been classified into Class II, as the Food and Drug Administration (FDA) has determined that special controls in addition to general controls will provide a reasonable assurance of safety and…
The Food and Drug Administration has classified the surgical smoke precipitator into Class II (special controls) as it has determined that special controls, in addition to general controls, will provide a reasonable assurance of safety and effectiveness1. The Agency believes…
The Food and Drug Administration has determined that special controls, in combination with general controls, provide a reasonable assurance of the safety and effectiveness of the non-absorbable, haemostatic gauze for temporary internal use1. Therefore, the Agency has classified this device…
The temporary catheter for embolic protection during transcatheterintracardiac procedures has been classified into Class II (special controls) following a Food and Drug Administration (FDA) review of a classification request1. This device type is identified as a single-use percutaneous catheter system…
Following a review of information submitted in a classification request, the Food and Drug Administration has determined that the percutaneous nerve stimulator for substance use disorders can be classified into Class II with the establishment of special controls1. These special…
The Food and Drug Administration has classified the Lynch syndrome test system into Class II as it believes that special controls, in addition to general controls, will provide a reasonable assurance of safety and effectiveness for the device1,2. The lower…
Guidance on the classification of health products at the device-drug interface has been updated to reflect changes to the definition of a medical device introduced by Vanessa’s Law and to provide greater clarity to the description of Health Canada’s classification…
Health Canada has informed stakeholders, notably manufacturers and importers of medical devices, that it intends to propose regulatory changes to strengthen the post-market surveillance and risk management of medical devices in Canada1. These proposed changes to the Medical Devices Regulations…
Health Canada has announced clarifications of, and modifications to, the process of transitioning to the Medical Device Single Audit Program (MDSAP) in an effort to make it easier for manufacturers to transition by 1 January 20191. Manufacturers undergoing a full MDSAP…
Since 16 March 2018, high-level disinfectant and sterilant solutions (including contact lens disinfectants) intended for use on medical devices have been reclassified from drugs to Class II medical devices1 as part of an initiative intended to align better the regulatory…
Health Canada has announced it will establish a new division1 within the Therapeutic Products Directorate’s Medical Devices Bureau to create a more targeted pre-market review of digital health technologies, to adapt to rapidly changing technologies in digital health, and to…
On 1 April 2018, Health Canada’s revised fee structure came into effect1. In line with Section 4 of the 2011 Fees in Respect of Drugs and Medical Devices Regulations, every fee outlined by the Regulations must be increased annually by…
A consultation is being held until 26 May 2018 on a Draft Act amending the Federal Law on Medicinal Products and Medical Devices (Law on Therapeutic Products, HMG)1. This partial revision of the HMG aligns the Swiss regulations for medical…
Updates to chapter 4 (on medical devices) of Annex 1 to the Agreement between the European Community and the Swiss Confederation on mutual recognition in relation to conformity assessment have been published in the Official Journal of the European Union1.…
The Health Products Regulatory Authority of Ireland has published guidance to industry on the distribution of medical devices, in vitro diagnostic medical devices (IVDs), and their accessories1. The guidance specifies the obligations for distributors contained in Regulation 2017/745 on medical…
A reflection paper1 published in January 2018 responds to the increasing regulatory focus on quality, safety and performance aspects of devices integral to medicinal products, reflecting the growing complexity of some of these device components (e.g. auto-injectors, on-body pumps, and…
The Medical Device Coordination Group (MDCG) recently endorsed a description of the requirements for a future European medical device nomenclature1. According to Article 26 of Regulation 745/2017 on medical devices and Article 23 of Regulation 746/2017 on in vitro diagnostic…
A regulation on Health Technology Assessment (HTA) to cover new medicines and certain new medical devices has been proposed to provide the basis for permanent and sustainable cooperation at the Member State level in this area1,2. The proposed mechanism for…
All European Union (EU) primary and secondary legislation will cease to apply to the UK from 30 March 2019 – its date of withdrawal from the EU – unless a ratified withdrawal agreement establishes another date. The European Commission has reminded1…
