Comments are being sought until 6 March 2017 on a draft guidance for industry and Food and Drug Administration staff entitled, Premarket Notification (510(k)) Submissions for Bone Anchors1,2. This draft guidance contains proposed recommendations for information to include in pre-market…
Guidance has been drafted to recommend the addition of a specific safety statement to the product labelling of certain ultrasonic surgical aspirator devices1,2. The proposal is for manufacturers of ultrasonic surgical aspirator devices with a general indication for use in…
A deadline of 13 April 2017 has been set for submitting comments on the draft guidance entitled How to Prepare a Pre-Request for Designation (Pre-RFD) before work begins on the final version of the guidance1. The Pre-RFD process allows sponsors…
Interested parties have until 19 April 2017 to submit comments on the draft guidance for industry and review staff entitled, Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities – Questions and Answers1. This draft guidance provides…
Guidance has been drafted1,2 on how the Food and Drug Administration (FDA) evaluates a company’s medical product communications, including promotional materials, that present information that is not contained in the FDA-required labelling but that may be consistent with the FDA-required…
The Food and Drug Administration (FDA) and the Office for Human Research Protections have jointly issued a guidance entitled, Use of Electronic Informed Consent – Questions and Answers1,2. The guidance is aimed at Institutional Review Boards (IRBs), investigators and sponsors…
Guidance entitled Current Good Manufacturing Practice [cGMP] Requirements for Combination Products1 has been published to provide background information on combination products, an overview of the 2013 document on cGMP requirements for combination products2, and the role of the lead Center…
In an effort to support hearing aid innovation and to improve affordability and patient access, the Food and Drug Administration (FDA) has issued an immediately-in-effect guidance document to communicate that it does not intend to enforce certain conditions for sale…
Medical device manufacturers have been provided with updated guidance in a question-and-answer format on meeting applicable reporting and recordkeeping requirements for certain device-related adverse events and malfunctions1,2. This guidance updates the Food and Drug Administration’s policy and clarifies the Agency’s…
A guidance document has been produced for the medical device industry and for Food and Drug Administration (FDA) staff to clarify the regulation of accessories to medical devices1,2. The guidance document describes the types of devices that the Agency generally…
Neurological devices intended to slow disease progression and improve clinical outcomes that are meaningful to patients may represent a revolutionary option for patients. Guidance published by the Food and Drug Administration (FDA) provides considerations for the research and development of…
The Food and Drug Administration (FDA) has released guidance entitled, Mitigating the Risk of Cross-Contamination from Valves and Accessories Used for Irrigation through Flexible Gastrointestinal Endoscopes1,2. This guidance highlights the cross-contamination risk posed by specific practices and types of irrigation…
A final guidance document has been published1,2 to provide an updated and detailed description of the information that should be included in a pre-market notification (510(k)) for a Magnetic Resonance Diagnostic Device (MRDD). This guidance supersedes the Guidance for Industry:…
New guidance1,2 from the US Food and Drug Administration (FDA) addresses the inclusion of a boxed warning and patient decision checklist in the product labelling for permanent, hysteroscopically-placed tubal implants intended for female sterilisation, as well as the content and…
The Center for Devices and Radiological Health’s (CDRH’s) policy for notifying the public about medical device ‘emerging signals’ has been described in a recent guidance document from the Food and Drug Administration1,2. An emerging signal is defined as new information…
Through the publication of Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions1,2, the Food and Drug Administration aims to clarify the factors that it considers when assessing risks and anticipated benefits for Investigational Device Exemption…
Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions have been published by the Food and Drug Administration (FDA) in the form of a final guidance document1,2. This guidance provides clarification for both FDA staff…
The Food and Drug Administration (FDA) has outlined its recommendations for managing post-market cybersecurity vulnerabilities for marketed and distributed medical devices in a new guidance document1,2. The guidance applies to any marketed and distributed medical device, including medical devices that…
Specific data must be submitted through a new electronic system called the Automated Commercial Environment (ACE) when a product regulated by the Food and Drug Administration (FDA) is offered for import into the USA. The ACE system is operated by…
The Food and Drug Administration (FDA) has published a final rule1 to describe the circumstances in which a product made or derived from tobacco that is intended for human consumption will be subject to regulation as a drug, device or…
Regulations have been published to set out the specific post-marketing safety reporting requirements that apply to combination products in the USA1. These rules apply when two or more different types of regulated medical products (drugs, devices and/or biological products, referred…
Antigen based rapid influenza virus antigen detection test systems intended to detect influenza virus directly from clinical specimens, which are currently regulated as influenza virus serological reagents, are being reclassified from Class I into Class II (special controls) and into…
Surgical instrumentation for use with urogynaecologic surgical mesh has been up-classified from Class I (general controls) exempt from pre-market notification to Class II (special controls) and subject to pre-market notification1. The device’s identification has also been modified to ‘specialized surgical…
The Food and Drug Administration (FDA) has classified the neurovascular mechanical thrombectomy device for acute ischaemic stroke treatment into Class II (special controls)1. The special controls that apply to the device form part of the codified language for the device’s…
A final rule took effect on 18 January 2017 to rename paediatric hospital beds, create a new classification for medical bassinets, and establish specific special controls for each device type1. In addition, use of paediatric medical cribs and medical bassinets…
Eustachian tube balloon dilation systems have been classified into Class II (special controls) in order to provide a reasonable assurance of their safety and effectiveness1. The classification has been codified by the addition of Title 21 of the Code of…
Computerised cognitive assessment aids for concussion have been classified1 into Class II (special controls) and the classification has been codified by the addition of §882.1471 to Title 21 of the Code of Federal Regulations. This device type is not exempt…
Pedicle screw systems (pre-amendments Class III devices regulated under product code NKB) have been reclassified into Class II (special controls) and renamed as ‘thoracolumbosacral pedicle screw systems’1. In addition, dynamic stabilisation systems (a subtype of pedicle screw systems regulated under…
The Food and Drug Administration (FDA) has determined that powdered surgeons’ gloves, powdered patient examination gloves, and absorbable powder for lubricating a surgeon’s gloves present an unreasonable and substantial risk of illness or injury and that the risk cannot be…
On 13 December 2016, President Obama signed into law the 21st Century Cures Act, bipartisan legislation that will mean significant investments in both innovative technologies and research1. The Act is divided into three sections: 21st Century Cures, Helping Families in…
In the final quarter of 2016, Health Canada issued an update to the Therapeutic Products Directorate’s (TPD’s) List of Recognized Standards for Medical Devices1. The changes consist of the addition of nine new standards, nine new editions of currently-recognised standards…
Health Canada has provided guidance to manufacturers and regulatory representatives on preparing medical device licence and licence amendment applications for dermal fillers1. All Class III and Class IV medical devices, including dermal fillers, require a review of submitted evidence of safety…
Medical device regulatory activities are now accepted in the ‘non-electronic Common Technical Document (eCTD) electronic-only’ format1-3. Until the Regulated Product Submission (RPS) format has been implemented, non-eCTD electronic-only will be the only format accepted by Health Canada for medical device…
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has proposed increasing its fees significantly from April 2017 in order to collect an additional £221,000 annually1. The current fees charged by the MHRA do not recover fully the costs of…
Swissmedic, the Swiss Agency for Therapeutic Products, has decided to follow the harmonised European approach for handling CE mark certifications of manufacturers affected by the de-designation of their Notified Bodies1. Like its counterpart in France, Swissmedic has established a period…
In anticipation of the implementation of the new European Regulations on medical devices and in vitro diagnostics, Sweden has proposed to transfer responsibility for Notified Bodies from the Swedish Board for Accreditation and Conformity Assessment (SWEDAC) to the Medical Products…
The French National Agency for the Safety of Medicines and Health Products (ANSM) has issued steps1,2 for medical device manufacturers to follow if their Notified Bodies cease operations, either voluntarily or following a de-notification decision. Currently, there is no European…
Members of the European Diagnostic Manufacturers Association (EDMA) and the European Medical Device Manufacturers Association (Eucomed) voted to dissolve their respective European associations and create a new, single entity to represent the European medical technology sector: MedTech Europe1. EDMA and…
At the 39th meeting of the Competent Authorities for Medical Devices (CAMD) in Bratislava, Slovakia, the Joint Action on Market Surveillance of Medical Devices was officially launched, with the UK Medicines and Healthcare products Regulatory Agency taking the lead1. The…
The formal adoptions of the new Regulations for medical devices and in vitro diagnostics (IVDs) are currently foreseen for the spring of 20171. They will be published in the Official Journal shortly thereafter, and enter into force on the 20th…
A public consultation has been held on a preliminary Opinion entitled, The need for non-human primates in biomedical research, production and testing of products and devices1, from the European Commission’s Scientific Committee on Health, Environmental and Emerging Risks (SCHEER). Comments…
A draft Commission Decision has been developed1 to update the Common Technical Specifications, as set out in Article 5.3 of Directive 98/79/EC, for certain in vitro diagnostic medical devices (IVDs) according to the current state-of-the-art. These IVDs are hepatitis C…
On 16 February 2017, the Court of Justice of the European Union delivered its judgment1 on the case concerning breast implants manufactured by Poly Implant Prothèse (PIP) using inferior quality industrial silicone. The Court found that, under Directive 93/42/EEC, a…
The European Parliament1 has formally endorsed the new Medical Devices Regulation (MDR)2 and the new In vitro Diagnostics Regulation (IVDR)3. The next step is for publication of the two Regulations in the Official Journal, which is expected to take place…
On 21 June 2017, the European Committee for Standardization (CEN), the European Committee for Electrotechnical Standardization (CENELEC) and the Eurasian Economic Commission (EEC) signed a joint Memorandum of Understanding to pave the way for closer collaboration on various aspects of…
Amendments have been proposed to the Law on Preparation and Implementation of Technical Legislation on Products, No 4703 of 2001, concerning the registration, traceability and follow-up of medical devices marketed in Turkey1. The draft Regulation (to amend the Law) requires…
The Taiwan Food and Drug Administration (TFDA) has completed a period of consultation on a new draft Medical Devices Act, which will formalise the separation of medical device legislation from that for drugs, i.e. the Pharmaceutical Affairs Act. It is…
Stakeholders have been provided with an opportunity to comment on a draft guidance document, GN-33, concerning the application of SS 620: 2016, Singapore Standard for Good Distribution Practice for Medical Devices – Requirements (SS GDPMDS)1. The draft guidance does not…
A tentative launch date of 1 August 2017 has been set for Singapore’s new Pre-Market Consultation (PMC) Scheme and the new Priority Review Scheme1. The PMC Scheme has been developed to support innovation and device development by ensuring that devices…
Updated guidance on the requirements for clinical investigations of medical devices has been published by the Saudi Food and Drug Authority (SFDA) as MDS-G20, version 2.01. Any clinical investigations of medical devices conducted within Saudi Arabia must receive approval from…
