Health Canada has proposed a second phase of regulatory amendments to the Medical Devices Regulations1. These amendments will help to deliver on commitments outlined in Health Canada’s 2024–2026 Forward Regulatory Plan and Stock Review Plan to modernise compliance and enforcement…
Interested parties have until 8 March 2025 to submit comments on proposed amendments to the Food and Drug Regulations and the Medical Devices Regulations (MDR) concerning shortages and discontinuation of sale of drugs and medical devices1. The proposed changes are…
Comments are being accepted until 3 March 2025 on a proposal for a Resolution that provides for the use of health risk management criteria and monitoring of company compliance for the purposes of initially granting or renewing the Certificate of…
The Brazilian National Health Surveillance Agency (Anvisa) has updated1 its rules on Operating Licences (Autorização de Funcionamento) for storage facilities in special warehouses and importers of medical device components. The updated rules apply to finished products that are regulated by…
A new business intelligence platform has been launched to provide information on clinical investigations involving medical devices authorised in Brazil1. This business intelligence platform provides transparency into the status of the Agency’s approvals by allowing users to consult various data,…
The National Health Surveillance Agency (Anvisa) issued Circular Letter 01/2024/SEI/GGTPS/DIRE3/ANVISA to companies holding medical device registrations and notifications, with guidance on the requirements for submitting documents that require sworn translations and legally valid signatures for applications relating to medical devices1.…
Anvisa – the National Health Surveillance Agency – has approved a list of priority Foreign Regulatory Authorities in an effort to develop and consolidate the practice of regulatory trust (known as reliance) in relation to the decisions it takes1. The…
The Therapeutic Goods (Medical Devices – Information that Must Accompany Application for Inclusion) Amendment Determination (No. 3) 20241 was published on 13 December 2024 to amend the Therapeutic Goods (Medical Devices – Information that Must Accompany Application for Inclusion) Determination…
The Therapeutic Goods Administration (TGA) has provided sponsors with advance notice1 of the final package of the recall reforms that will be implemented in early March 2025. This includes providing a preview of Australia’s new recall procedure: the Procedure for…
Feedback is being sought until 17 February 2025 on two new guidance documents developed as part of the proposed new risk-based application audit framework: Selection criteria for non-mandatory application audits1 This guidance document outlines and clarifies the selection criteria…
The National Administration of Drugs, Food and Medical Devices (ANMAT) has announced1 the implementation of ANMAT Provision 64/25 for the registration procedures of medical products, which came into force on 21 January 2025. ANMAT Provision 64/25 incorporates into Argentina’s national…
In September 2024, the Ministry of Health published Official Dispatch No. 365/HTTB-ĐKKD1 regarding applications for a licence to import medical equipment submitted before 1 January 2022 where the import licence has not yet been granted. For import dossiers submitted before…
A guidance document entitled Acceptable Media for Electronic Product User Manuals, which was originally published in March 2010, has been updated to clarify that manufacturers can provide user manuals accompanying electronic products in either paper or electronic form1. This action…
The Food and Drug Administration (FDA) has made minor, technical modifications1 to the Voluntary Malfunction Summary Reporting (VMSR) programme, which permits manufacturer reporting of certain device malfunction medical device reports in summary form on a quarterly basis. The modifications apply…
The Center for Devices and Radiological Health’s (CDRH’s) Customer Collaboration Portal (CDRH Portal) has been updated1 to allow users to: Submit Small Business Determination (SBD) requests. From 1 November 2024, all SBD requests (Form 3602 and Form 3602A, and other…
Guidance has been issued1 to set out updated procedures for submitting, reviewing, and responding to requests for information regarding the class in which a device has been classified or the requirements applicable to a device under the Federal Food, Drug,…
Association for the Advancement of Medical Instrumentation (AAMI) technical information report (TIR) 99:2024, Processing of dilators, transesophageal and ultrasound probes in health care facilities, provides guidance on the proper processing of dilators and ultrasound probes in healthcare facilities to assist…
Four, final device-specific guidance documents for the Safety and Performance Based Pathway were published on 30 September 20241, with a fifth published on 15 October 20242: Dental Ceramics – Performance Criteria for Safety and Performance Based Pathway3; Dental Cements…
Interested parties have until 25 November 2024 to submit comments on a proposed order to reclassify hepatitis B virus (HBV) assay devices from Class III to Class II1. The following HBV assays are proposed for reclassification from Class III to…
Special controls, in addition to general controls, will provide a reasonable assurance of the safety and effectiveness of radiofrequency toothbrushes, according to the Food and Drug Administration, so these devices are being classified into Class II (special controls)1. The classification…
In response to a de novo classification request, the Food and Drug Administration has classified1 the quantitative viral nucleic acid test for transplant patient management into Class II (special controls) and has codified the classification at Title 21 of the…
On 23 October 2024, a final order1 took effect to reclassify cytomegalovirus (CMV) deoxyribonucleic acid (DNA) quantitative assay devices intended for transplant patient management – a post-amendments Class III device with product code PAB – into Class II (special controls),…
In response to a de novo classification request, the Food and Drug Administration (FDA) has classified the intravenous (IV) catheter force-activated separation device into Class II (special controls)1. The FDA has determined that special controls, in combination with general controls,…
Intervertebral body graft containment devices have been classified into Class II (special controls) in response to a de novo classification request received by the Food and Drug Administration (FDA)1. An intervertebral body graft containment device is a non-rigid, implanted spinal…
The Food and Drug Administration (FDA) has classified the heparin and direct oral factor Xa inhibitor drug test system into Class II (special controls) as it believes that special controls, in combination with general controls, will provide a reasonable assurance…
Final guidance entitled, Electronic Submission Template for Medical Device De Novo Requests, was released by the Food and Drug Administration (FDA) on 23 August 20241,2. This guidance builds on the guidance Providing Regulatory Submissions for Medical Devices in Electronic Format…
The guidance for industry and Food and Drug Administration staff concerning Application User Fees for Combination Products has been updated1. This revised document provides guidance on application user fees for combination products as defined under Title 21 of the Code…
Feedback is being solicited on draft guidance entitled Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle1,2. This draft guidance clarifies the principal concepts that sponsors and other interested parties should consider when choosing to collect and submit…
Guidance has been drafted1,2 to set out recommended methodological approaches for chemical analysis for biocompatibility assessment of medical devices in an effort to improve the consistency and reliability of analytical chemistry studies. The guidance has been deemed necessary as the…
On 1 October 2024, the Center for Devices and Radiological Health (CDRH) expanded1 its voluntary Total Product Life Cycle (TPLC) Advisory Program (TAP) Pilot to include breakthrough designated devices reviewed by the Office of Radiological Health (Office of Health Technology…
On 9 September 2024, three sterilisation standards were added to the Food and Drug Administration’s (FDA’s) recognised standards database1 for medical devices to help advance innovation in medical device sterilisation processes: ISO 11737-3:2023, Sterilization of health care products –…
The Food and Drug Administration (FDA) has published the medical device user fees for device submissions and annual fees both for periodic reports and registration of establishments for fiscal year (FY) 2025 (1 October 2024 to 30 September 2025)1. The…
Upon request, the Food and Drug Administration (FDA) has classified the endoscopic pancreatic debridement device as Class II (special controls), which it has determined will provide a reasonable assurance of safety and effectiveness1. The classification has been codified at Title…
Interested parties have until 20 November 2024 to submit comments on new draft guidance concerning Pre-determined Change Control Plans (PCCPs) for medical devices1,2. This draft guidance proposes a policy for PCCPs and recommendations on the information to include in a…
In response to a de novo classification request, digital therapy devices for Attention Deficit Hyperactivity Disorder (ADHD) have been classified into Class II (special controls)1. The classification has been codified at Title 21 of the Code of Federal Regulations §882.5803.…
Devices to detect and identify nucleic acid targets in respiratory specimens from microbial agents that cause the SARS-CoV-2 respiratory infection and other microbial agents when in a multi-target test have been classified into Class II (special controls)1. The classification has…
In response to a de novo classification request, the Food and Drug Administration has classified the device to detect or measure nucleic acid from viruses associated with head and neck cancers into Class II (special controls) and codified the classification at…
Comments are being solicited until 23 December 20241,2 on the following three draft guidance documents which, when finalised, will update the Accreditation Scheme for Conformity Assessment (ASCA) programme: The Accreditation Scheme for Conformity Assessment (ASCA) Program3; Biocompatibility Testing of…
The clozapine test system has been classified into Class II (special controls)1 as the Food and Drug Administration (FDA) believes that special controls, in addition to general controls, will address the risks to health associated specifically with this type of…
The Food and Drug Administration (FDA) has determined that classifying the whole exome sequencing constituent device into Class II (special controls) will provide a reasonable assurance of safety and effectiveness for the device type1. The special controls that apply to…
The paediatric continuous renal replacement therapy system has been classified into Class II (special controls)1. The special controls that apply to this device type are specified in the final order and form part of the codified language for the paediatric…
Upon request, the Food and Drug Administration (FDA) has classified the neuromuscular tongue muscle stimulator for the reduction of snoring and obstructive sleep apnoea into Class II (special controls)1. The Agency has determined that classifying the device into Class II…
In response to a de novo classification request, the Food and Drug Administration (FDA) has classified the haemodialyser with expanded solute removal profile into Class II (special controls) and has codified the classification at Title 21 of the Code of…
In response to a de novo classification request, the adjunctive open loop fluid therapy recommender has been classified into Class II (special controls), and the classification has been codified at Title 21 of the Code of Federal Regulations (21 CFR)…
Class II classification has been deemed appropriate by the Food and Drug Administration (FDA) for devices to detect and identify selected microbial agents that cause acute febrile illness1. A device to detect and identify selected microbial agents that cause acute…
Special controls have been established for the external compression device for internal jugular vein compression as part of its classification into Class II1. The Food and Drug Administration has codified the classification of the device by adding §890.3050 to Title…
The Food and Drug Administration has classified hydrophilic re-coating solution – a home-use device intended to restore the hydrophilic coating of rigid gas permeable contact lenses using reactive coating components – into Class II (special controls)1. The classification has been…
New guidance has been published1,2 that provides clarification to industry and Food and Drug Administration (FDA) staff on the Federal regulations that relate to diagnostic x-ray equipment (i.e. diagnostic x-ray systems and their major components). This guidance supersedes the FDA’s guidance…
A list of prioritised medical device guidance documents that the US Food and Drug Administration (FDA) plans to publish over the next 12 months (A list) has been posted on the website of the Center for Devices and Radiological Health…
To provide consumers and healthcare professionals with important information about clinical trials that supported the approval of new medical devices, the Center for Devices and Radiological Health (CDRH) is piloting1 providing device trial participation snapshots to highlight certain information about…
