New and revised medical device industry standards listed in Table CN1a have been recently approved and published1. The standard number, name, status and implementation date are detailed in the table. Table CN1a. New and revised medical device industry…
The following Guiding Principles have been released by the National Medical Products Administration1 and the Center for Medical Device Evaluation2: Guiding Principles for On-site Inspections of the Quality Management Standards for Online Sales of Medical Devices (26 September 2025);…
An update of the standards used for the sanitary control and verification of the conformity of sterile, single-use hypodermic needles and syringes, as previously established in Ministry of Health Exempt Decree No. 1887 of 27 December 2007, have been published1.…
The electronic Submission Template And Resource (eSTAR) is an interactive PDF form developed by the US Food and Drug Administration (FDA) that guides applicants through the process of preparing a comprehensive medical device submission. In 2023, Health Canada launched a…
Guidance has been published1 to help manufacturers understand the different application types listed in the Medical Devices Regulations, namely: medical device family; medical device group; medical device group family; system; test kit. The guidance also assists manufacturers in…
Public Consultation No. 24, dated 19 August 2025, concerns a proposal1 to amend Inmetro Ordinance No. 5 of 11 January 2022, which approved the consolidated conformity assessment requirements for breast implants. In Annex I (Compliance assessment requirements for breast implants),…
Information provided by the Therapeutic Goods Administration (TGA) on how clinical decision support system (CDSS) software is regulated, including when such products are and are not exempt from inclusion in the Australian Register of Therapeutic Goods (ARTG), was updated in…
Stakeholders have until 1 December 2025 to submit information on digital mental health tools (DMHTs) currently available in Australia1. The Therapeutic Goods Administration (TGA) is reviewing the regulations that apply to software-based medical devices – including DMHTs – that are…
In 2024, the Therapeutic Goods Administration (TGA) sought feedback on a consultation paper entitled, Clarifying and strengthening the regulation of Artificial Intelligence (AI), which included several proposals aimed at managing future risks and leveraging opportunities associated with the use of…
Information has been published1 to clarify when digital scribes are regulated as medical devices. Digital scribes are increasingly used in clinical settings to capture conversations between patients and healthcare practitioners. These tools generate clinical notes, summaries or letters which may…
On 16 October 2025, the Therapeutic Goods Administration published on its website Guidance on the regulatory framework for in vitro diagnostic (IVD) companion diagnostics (CDx) and for the medicine or biological that requires CDx testing1. The purpose of this guidance…
Selection criteria New guidance has been published1 to provide information on how the Therapeutic Goods Administration (TGA) selects medical device applications for audit, and is intended to help sponsors prepare and respond to a request for information if a device…
Guidance for manufacturers and sponsors on the cybersecurity of medical devices that include software or electronic components has been updated to align1 with the Procedure for Recalls, Product Alerts and Product Corrections (PRAC), which replaced the Uniform Recall Procedure for…
The Therapeutic Goods (Restricted Representations – Contact Lenses and Spectacle Lenses) Permission 2025 took effect on 1 October 20251. As a result, a representation that refers to correcting a refractive error of the eye or controlling the progression of myopia…
From 1 July 2025 to 31 December 2026, the collection of fees in the medical equipment sector will reduce by 50% according to Notification No. 645/TB-HTTB, dated 2 July 20251. Table VN1 lists these reduced fees applicable to medical devices.…
Zika virus serological reagents have been classified1 into Class II (special controls) and the classification has been codified at Title 21 of the Code of Federal Regulations §866.3935. Zika virus serological reagents are in vitro diagnostic devices that consist of…
The Center for Devices and Radiological Health has issued a reminder of an upcoming compliance date for de novo submissions. In accordance with the final guidance entitled Electronic Submission Template for Medical Device De Novo Requests1, all de novo submissions…
Upon request, the Food and Drug Administration (FDA) has classified the device to detect and identify microbial nucleic acids by fluorescence in situ hybridisation (FISH) in clinical specimens as Class II (special controls), as the Agency has determined that such…
In response to a de novo classification request, the Food and Drug Administration (FDA) has classified the radiological computer-assisted detection and diagnosis software into Class II (special controls), subject to the pre-market notification (510(k)) requirements1. The classification has been codified…
The reclassification of in situ hybridisation (ISH) test systems indicated for use with a corresponding approved oncology therapeutic product (product codes NYQ, MVD, OWE, and PNK) has been proposed from Class III (pre-market approval) into Class II (special controls), subject…
On 26 June 2025, the US Food and Drug Administration (FDA) published another update to its list of recognised consensus standards entitled Modifications to the List of Recognized Standards, Recognition List Number: 0641. These standards are intended to help manufacturers…
In response to a de novo classification request, the Food and Drug Administration (FDA) has classified the microbial nucleic acid storage and stabilisation device into Class II (special controls)1. A microbial nucleic acid storage and stabilisation device consists of a…
The Food and Drug Administration (FDA) has updated the final guidance entitled Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions1,2 to identify the cybersecurity information the Agency generally considers to be necessary to support obligations under…
Upon request, the lysosomal storage disorder newborn screening test system has been classified into Class II (special controls), subject to the pre-market notification requirements under section 510(k) of the Federal Food, Drug, and Cosmetic Act1. A lysosomal storage disorder newborn…
Classification into Class II (special controls) has been deemed appropriate for the inherited nucleotide repeat disorder deoxyribonucleic acid (DNA) test1 and the classification has been codified at Title 21 of the Code of Federal Regulations §866.5970. An inherited nucleotide repeat…
Comments are being solicited on a draft guidance for industry and Food and Drug Administration staff entitled, Unique Device Identifier (UDI) Requirements for Combination Products1,2. This draft guidance outlines the requirements, recommendations, and best practices for UDI labelling and for…
Final guidance was published1,2 at the end of May 2025 to provide an overview of the mechanisms available to submitters for requesting written feedback and/or a meeting with the Food and Drug Administration (FDA) relating to medical device submissions. The…
The fluorescence in situ hybridisation (FISH)-based detection of chromosomal abnormalities from patients with haematologic malignancies has been classified into Class II (special controls)1. This test is indicated for the clinical management of patients consistent with internationally accepted guidelines and in…
In May 2025, the Food and Drug Administration (FDA) announced1 its intention to expand the use of unannounced inspections at foreign manufacturing facilities that produce medical devices, foods, essential medicines, and other medical products intended for US consumers and patients.…
The Food and Drug Administration (FDA) has issued an order classifying the anti-mullerian hormone test system into Class II1 and has codified the classification at Title 21 of the Code of Federal Regulations §862.1092. An anti-mullerian hormone test system is…
Comments are being accepted until 5 August 2025 on a draft guidance entitled, Hernia Mesh – Package Labeling Recommendations1,2. This draft guidance provides labelling recommendations for hernia mesh devices that are intended to help promote the safe and effective use…
In response to a de novo classification request, the Food and Drug Administration (FDA) has classified the device to detect bacterial protease activity in chronic wound fluid into Class II (special controls)1 and codified the classification at Title 21 of…
The cytomegalovirus nucleic acid detection device for congenital cytomegalovirus infection has been classified into Class II (special controls)1 and the classification has been codified at Title 21 of the Code of Federal Regulations §866.3181. A cytomegalovirus nucleic acid detection device…
The Food and Drug Administration (FDA) has classified the cream for x-ray attenuation into Class II (special controls) as it believes that special controls, in addition to general controls, will provide a reasonable assurance of safety and effectiveness for the…
In response to a de novo classification request, the Food and Drug Administration (FDA) has classified the coagulation system for the measurement of whole blood viscoelastic properties in perioperative patients into Class II (special controls)1. The FDA has codified the…
The Food and Drug Administration (FDA) has classified1 the clinical mass spectrometry microorganism identification and differentiation system into Class II (special controls), subject to the pre-market notification (510(k)) requirements, and codified at the classification at §866.3378 of Title 21 of…
Upon request, the cellular analysis system for multiplexed antimicrobial susceptibility testing has been classified into Class II (special controls) by the Food and Drug Administration1. A cellular analysis system for multiplexed antimicrobial susceptibility testing is a multiplex qualitative and/or quantitative…
The Food and Drug Administration (FDA) has classified the muscular dystrophy newborn screening test into Class II (special controls) because it believes that special controls will provide a reasonable assurance of safety and effectiveness for the device1. A muscular dystrophy…
Devices to detect and measure non-microbial analytes to aid in the detection and identification of localised human infections have been classified into Class II (special controls) and the classification has been codified at Title 21 of the Code of Federal…
The Food and Drug Administration (FDA) has classified the temporarily placed urethral opening system for symptoms of benign prostatic hyperplasia into Class II (special controls)1. The Agency has taken this action because it has determined that classifying the device into…
Upon request, the Food and Drug Administration has classified the radiological acquisition and/or optimisation guidance system as Class II (special controls)1. This action should enhance patient access to beneficial innovation, in part by reducing regulatory burdens by placing the device…
The plazomicin test system has been classified into Class II (special controls)1 and the classification has been codified by the addition of §862.3460 to Title 21 of the Code of Federal Regulations. The Food and Drug Administration (FDA) has taken…
In response to a de novo classification request, the herpes simplex virus (HSV) nucleic acid-based assay for central nervous system (CNS) infections has been classified into Class II (special controls)1 and the classification has been codified at §866.3307 of Title…
The Food and Drug Administration has classified the deoxyribonucleic acid (DNA)-based test to measure minimal residual disease in haematological malignancies into Class II (special controls)1. The Agency has taken this action because it has determined that classifying the device into…
The Food and Drug Administration (FDA) has classified the device to detect nucleic acids from non-viral microorganism(s) causing sexually transmitted infections and associated resistance marker(s) into Class II (special controls). The special controls that apply to the device type are…
The device to detect and identify fungal nucleic acids directly in respiratory specimens has been classified into Class II (special controls)1. This action has been taken by the Food and Drug Administration as it believes that classifying the device into…
An Order came into effect on 18 June 2025 to exempt certain Class II clinical electronic thermometers from the pre-market notification (510(k)) requirements, subject to certain limitations1. This exemption from the 510(k) requirements should decrease regulatory burdens on the medical…
A breast milk macronutrients test system is a device intended to quantitatively measure fat, protein, and total carbohydrate content in human breast milk. These measurements, in conjunction with other clinical assessments, may be used to aid in the nutritional management…
Final guidance has been published1,2 to describe the Food and Drug Administration’s (FDA’s) current thinking on its use of remote regulatory assessments (RRAs) and to provide answers to frequently asked questions on RRAs. The final guidance makes further revisions to,…
Interested parties have until 4 August 2025 to submit comments to the Food and Drug Administration (FDA) on a draft guidance entitled, Transfer of a Premarket Notification (510(k)) Clearance – Questions and Answers1,2. This guidance provides information on the most…
