Three new guidance documents – one final and two draft – offer additional clarity on the Food and Drug Administration’s (FDA’s) role in digital health, including where there is no need for FDA involvement. The first guidance document is entitled…
A specific safety statement should be added to the product labelling of certain ultrasonic surgical aspirator devices according to a recent guidance document from the Food and Drug Administration1,2. Ultrasonic surgical aspirator devices are surgical tools intended to fragment, emulsify…
Manufacturers are being encouraged to consider child safety when designing X-ray imaging devices by a new final guidance document entitled, Pediatric Information for X-ray Imaging Device Premarket Notifications1,2. The guidance applies both to new devices and to modifications requiring the…
Guidance has been issued that modifies the Food and Drug Administration’s current policy on the categorisation of Investigational Device Exemption (IDE) devices, which assists the Centers for Medicare and Medicaid Services (CMS) in determining whether or not an IDE device…
A new leapfrog guidance document has been issued to provide the Food and Drug Administration’s initial thoughts on the technical considerations specific to devices using additive manufacturing, the broad category of manufacturing encompassing 3-dimensional (3D) printing1,2. The purpose of this…
The Food and Drug Administration has published guidance1,2 to clarify its stance on manufacturers appropriately and responsibly sharing ‘patient-specific information’ with that patient at that patient’s request. The guidance provides information and recommendations to industry, healthcare providers and Agency staff…
Updated final guidance has been published on medical device accessories and their classification pathways1. The guidance describes the Food and Drug Administration’s (FDA’s) policy for the classification of accessories and discusses the application of this policy to devices that are…
A guidance document entitled Unique Device Identification: Direct Marking of Devices1,2 has been issued by the Food and Drug Administration in order to clarify when direct marking of devices with a unique device identifier (UDI) is required, and to assist…
A new, immediately-in-effect guidance document1,2 sets out the Food and Drug Administration’s policy regarding Unique Device Identification (UDI) compliance dates for Class I and unclassified medical devices. UDI requirements are being phased in over seven years according to a schedule…
A new guidance document entitled De Novo Classification Process (Evaluation of Automatic Class III Designation) has been published1,2 by the Food and Drug Administration (FDA) to provide information on the process for the submission and review of a de novo…
Guidance has been published to assist industry and Food and Drug Administration staff in determining when a software (including firmware) change to a medical device may require a manufacturer to submit and obtain clearance of a new pre-market notification (510(k))1,2.…
New guidance has been published1,2 in an effort to define with greater clarity when a change in a medical device would trigger the requirement that a manufacturer submit a new pre-market notification (510(k)) to the Food and Drug Administration (FDA).…
Comments are open until 17 April 2018 on a proposed rule1 to implement regulations on the procedures for internal agency supervisory review of certain decisions made by the Center for Devices and Radiological Health (CDRH) under the Federal Food, Drug…
Interested parties had until 29 January 2018 to submit comments on a proposal to exempt certain subtypes of surgical apparel from the pre-market notification (510(k)) requirements, subject to conditions and limitations1. The proposed exemption applies to single-use, disposable respiratory protective…
A rule has been published that proposes1 delaying 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, devices…
A proposed order has been issued1 to reclassify the needle destruction device – a post-amendments Class III device regulated under product code MTV – into Class II (special controls), subject to pre-market notification, and with a name change to the…
On its own initiative and based on new information, the Food and Drug Administration (FDA) has proposed the reclassification of single-use female condoms (post-amendments Class III devices with product code MBU) into Class II (special controls) subject to pre-market notification…
A correction has been issued1 to a Final Order entitled Medical Devices; Gastroenterology-Urology Devices; Classification of the Oral Removable Palatal Space Occupying Device for Weight Management and/or Weight Loss, which was published in the Federal Register on 28 July 20172.…
Autosomal recessive carrier screening gene mutation detection system devices are now exempt1 from pre-market notification (510(k)) requirements, subject to certain limitations, and the codified classification regulation for these devices has been amended to reflect this change. The 510(k) exemption, subject…
Reagents for molecular diagnostic instrument test systems have been classified into Class I (general controls)1 and the classification has been codified at Title 21 of the Code of Federal Regulations (21 CFR) 862.3800. These devices are reagents (other than analyte-specific reagents)…
The cervical intraepithelial neoplasia (CIN) test system has been classified into Class II (special controls) and is subject to the pre-market notification (510(k)) requirements1. A CIN test system is used to detect a biomarker associated with CIN in human tissues.…
The Food and Drug Administration has determined that classification of the absorbable perirectal spacer into Class II (special controls) will provide a reasonable assurance of safety and effectiveness1. The action should also enhance patients’ access to beneficial innovation, in part…
The Food and Drug Administration has determined1 that Class II (special controls) will provide a reasonable assurance of safety and effectiveness for the prostatic artery embolisation device, so the classification has been codified at Title 21 of the Code of…
Following a de novo classification request, the Food and Drug Administration (FDA) has classified the BCR-ABL quantitation test into Class II (special controls)1. A BCR-ABL quantitation test is a reverse transcription-quantitative polymerase chain reaction (RT-qPCR) test for the quantitation of…
The Streptococcus spp nucleic acid-based assay has been classified into Class II (special controls)1 after review of a de novo request. The Streptococcus spp nucleic acid-based assay is a qualitative in vitro diagnostic device that is intended simultaneously to detect…
The acute kidney injury test system, which is a device intended to measure one or more analytes in human samples as an aid in the assessment of a patient’s risk of developing acute kidney injury, has been classified into Class…
The Food and Drug Administration has issued a Final Order classifying the Aquaporin-4 autoantibody immunological test system into Class II1. The classification has been codified by the addition of §866.5665 to Title 21 of the Code of Federal Regulations. The…
The newborn screening test for severe combined immunodeficiency disorder (SCID) has been classified1 into Class II, and the special controls that apply to the device type are identified in §866.5930 of Title 21 of the Code of Federal Regulations. This…
The total 25-hydroxyvitamin D mass spectrometry test system has been classified into Class II (special controls)1. This device is intended for use in clinical laboratories for the quantitative determination of total 25-hydroxyvitamin D (25-OH-D) in serum or plasma to be…
The automated indirect immunofluorescence microscope and software-assisted system has been classified into Class II (special controls)1. An automated indirect immunofluorescence microscope and software-assisted system is identified as a device that acquires, analyses, stores and displays digital images of indirect immunofluorescent…
Following a review of the information submitted in a de novo request, the Food and Drug Administration (FDA) has determined that the non-electroencephalogram (EEG) physiological signal based seizure monitoring system can be classified into Class II with the establishment of…
It has been established that Class II (special controls) will provide a reasonable assurance of safety and effectiveness for the genetic health risk assessment system1. The special controls that apply to this device type form part of the codified language…
Following a de novo classification request, the Food and Drug Administration has determined that the tear electrostimulation device can be classified into Class II with the establishment of special controls1. These special controls, in addition to general controls, will provide…
The foetal head elevator has been classified as Class II (special controls) following the Food and Drug Administration’s (FDA’s) review of a de novo classification request1. The Agency believes lowering the classification from the automatic Class III designation should enhance…
The whole slide imaging system has been classified1 into Class II and the special controls that apply to it form part of the codified language for the classification at Title 21 of the Code of Federal Regulations §864.3700. The Food…
Upon request, the Food and Drug Administration (FDA) has classified the irrigating wound retractor device into Class II (special controls)1 and codified the classification by adding §878.4371 to Title 21 of the Code of Federal Regulations. An irrigating wound retractor…
The computerised behavioural therapy device for psychiatric disorders has been classified into Class II (special controls)1 and the classification has been codified by the addition of §882.5801 to Title 21 of the Code of Federal Regulations. A computerised behavioural therapy device…
The Food and Drug Administration has classified the flow cytometric test system for haematopoietic neoplasms into Class II (special controls)1. A flow cytometric test system for haematopoietic neoplasms consists of reagents for immunophenotyping of human cells in relation to the…
Upon request, the Food and Drug Administration has classified the rectal balloon for prostate immobilisation into Class II (special controls), as it believes this classification will provide a reasonable assurance of the device’s safety and effectiveness1. A rectal balloon for…
The Food and Drug Administration (FDA) has classified the external vagal nerve stimulator for headache, which is a prescription device used to apply an electrical current to a patient’s vagus nerve through electrodes placed on the skin for the treatment…
Classification into Class II has been applied to the pressure wedge for the reduction of Caesarean delivery1. This device, which is for prescription use only, provides external mechanical support to the perianal region during the labour and vaginal delivery process…
After a review of the information submitted in a de novo request, the Food and Drug Administration has determined that the image processing device for estimation of external blood loss can be classified into Class II with the establishment of…
The Food and Drug Administration has classified the external negative pressure airway aid into Class II (special controls)1. The special controls that apply to the device type are identified in the codified language for the external negative pressure airway aid’s classification…
At the last moment, the US House and the US Senate have both passed a bill that suspends the controversial 2.3% medical device excise tax on the sale of a taxable medical device by the manufacturer, producer or importer for…
During the summer of 2018, Health Canada is considering piloting the Regulatory Enrolment Process (REP) using the Common Electronic Submission Gateway (CESG) for medical device applications1. The REP is currently being piloted by Health Canada for product types such as…
The 90-day consultation period on the Draft Guidance Document: Applications for Medical Device Investigational Testing Authorizations (ITAs) ends on 16 February 20181. This draft guidance reflects Health Canada’s current thinking on ITAs for medical devices; it clarifies the application requirements…
Manufacturers of Class IV human immunodeficiency virus (HIV) rapid diagnostic tests (RDTs) intended to be used at the point of care and/or for self-testing have been provided with guidance1 on the analytical and clinical data, and the device labelling, required…
Changes have been proposed to the Medical Devices Regulations concerning the public release of clinical information1. Interested parties have 75 days after the date of publication of the proposal in the Canada Gazette (9 December 2017) to submit their comments…
The Radiation Emitting Devices Regulations have been amended to update the regulatory requirements for dental X-ray equipment1 in order to enable Health Canada to exercise appropriate regulatory oversight of their sale, re-sale, lease and importation in Canada, and ultimately to…
Following concerns raised by industry, Health Canada has streamlined its Medical Device Single Audit Program (MDSAP) audit approach in the revised version of the audit model to reduce the total number of tasks that need to be accomplished, thereby reducing…
