Search Results for medical devices

Showing 1 – 25  of 64

TGA Weighs Changes to Regulations for Personalized, 3D Printed Devices By Michael Mezher - Published 09 November 2017

Australia's Therapeutic Goods Administration (TGA) on Thursday launched a consultation on proposed changes to the country's medical device regulations for personalized and 3D printed medical devices.

Categories: News, Oceania, TGA, Manufacturing, Medical Devices, Submission and registration

Tags: 3D-Printing, Custom Medical Devices

How Price Caps in India are Forcing US Device Companies to Sell Stents and Implants at a Loss By Zachary Brennan - Published 18 October 2017

Hypothetical talk circulating on Capitol Hill this week around the idea of price ceilings for certain pharmaceuticals set off alarm bells for industry. But on the medical device side, companies are already seeing what happens when a government, in this case India, sets price caps for certain devices and mandates that companies remain in the market and take a loss on sales.

Categories: News, India, US, MHLW, Government affairs, In vitro diagnostics, Medical Devices, Reimbursement

Tags: stents, knee implants, India price ceilings, medical devices in india

IMDRF Consults on Use of Registries to Support Device Approval Decisions By Zachary Brennan - Published 02 October 2017

The International Medical Device Regulators Forum (IMDRF) has opened for consultation until 1 December a third document on examining the use of registries to support medical device regulatory decision making.

Categories: News, Asia, Canada, Europe, US, IMDRF, In vitro diagnostics, Medical Devices, Postmarket surveillance, Regulatory intelligence, Regulatory strategy

Tags: registry data and medical devices, medical device data, approval decisions and registries

Does FDARA Open the Door to Third-Party Reviews of Implantable Devices? Lawyer Discusses By Zachary Brennan - Published 29 September 2017

Thanks to the new user fee legislation known as the FDA Reauthorization Act (FDARA), the Food, Drugs and Cosmetics Act (FDCA) has been amended to allow for third-party reviews of Class II devices intended to be permanently implantable, life-sustaining or life-supporting.

Categories: News, US, FDA, Medical Devices

Tags: third-party review of medical devices, FDARA, implantable devices

UK’s MHRA Unveils Human Factors Guidance for Medical Devices By Zachary Brennan - Published 19 September 2017

As part of its work to minimize the risks from use error and promote safe practices, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Tuesday released new guidance on human factors and usability engineering for medical device manufacturers.

Categories: News, Europe, EC, MHRA, Combination products, Government affairs, In vitro diagnostics, Medical Devices

Tags: human factors guidance for medical devices, MHRA guidance, MDR

CDRH Finalizes Guidance on Reporting Age, Race and Ethnicity Data in Studies Published 12 September 2017

The final guidance outlines FDA’s recommendations and expectations for patient enrollment, data analysis, and reporting of age, race and ethnicity data in medical device clinical studies.

Categories: News, US, CDRH, Clinical, In vitro diagnostics, Medical Devices

Tags: medical devices, final FDA guidance

FDA Finalizes Guidance on Interoperable Devices By Zachary Brennan - Published 05 September 2017

The US Food and Drug Administration (FDA) on Tuesday finalized guidance outlining recommendations on how medical devices should be able to securely interact with other devices and information systems.

Categories: News, US, CDRH, Medical Devices, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: interoperable medical devices, EHRs and devices

FDA Finalizes Guidance on Using Real World Evidence for Medical Device Regulatory Decisions By Zachary Brennan - Published 30 August 2017

The US Food and Drug Administration (FDA) has finalized a slightly tweaked guidance on medical device companies’ use of real-world data (RWD) and real-world evidence (RWE) in winning approvals for their products.

Categories: News, US, CDRH, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: real world evidence and medical devices, real world data and FDA

FDA Finalizes List of 1,003 Class II Device Types Exempt From 510(k) Requirements By Zachary Brennan - Published 10 July 2017

The US Food and Drug Administration (FDA) on Monday finalized a list of 1,003 types of class II medical devices that the agency believes do not present risks that require premarket notification review to provide a reasonable assurance of safety and effectiveness.

Categories: News, US, FDA, Government affairs, In vitro diagnostics, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: 510(k), device exemptions, 21st Century Cures, Class II medical devices

FDA Unveils List of Reusable Devices Requiring New Validation Data By Zachary Brennan - Published 08 June 2017

Following superbug outbreaks after issues with reprocessing certain medical devices, the US Food and Drug Administration (FDA) on Thursday released a list of devices that the agency will require validated instructions for use and validation data regarding cleaning, disinfection and sterilization in premarket notification submissions. 

Categories: News, US, CDRH, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: reprocessed medical devices, reusable devices, 21st Century Cures, 510(k)

UK's NICE to Launch New Online Tool for Med Tech Developers Published 31 May 2017

The UK's National Institute for Health and Care Excellence (NICE), which often determines if the UK can afford to pay for certain treatments, will launch a new online tool in July to help developers of medical devices and diagnostics understand how to generate the evidence necessary to show their products are clinically and cost effective.

Categories: News, Europe, NICE, In vitro diagnostics, Medical Devices, Regulatory intelligence, Regulatory strategy, Reimbursement

Tags: NICE, medical technologies, medical devices, cost effectiveness of medical tech

European Commission: Cranberry Products Are Not Medical Devices By Zachary Brennan - Published 26 May 2017

The European Commission's regulatory committee on medical devices on 19 May voted in favor of the commission's decision that products "whose principal intended action, depending on proanthocyanidins (PAC) present in cranberry extract, is to prevent or treat cystitis," also known as bladder inflammation or infection, "are not medical devices within the meaning of Article 1 (2) (a) of the Medical Devices Directive."

Categories: News, Europe, EC, EMA, Medical Devices

Tags: cranberries, UTIs, bladder infections, medical devices and cranberries

Australia Considers Allowing the Marketing of Devices Approved Overseas By Zachary Brennan - Published 22 May 2017

Australia’s Therapeutic Goods Administration (TGA) on Monday unveiled a plan to further converge its medical device regulations with those from comparable overseas regulators and allow for the use of devices that have received marketing approvals from some foreign authorities.

Categories: News, Oceania, TGA, Government affairs, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: Australia's TGA, medical devices in Australia, conformity assessments, regulation of devices

MHRA Plans for the Future of Drug, Device Regulation Post-Brexit By Zachary Brennan - Published 21 April 2017

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Friday released a business plan for the upcoming year, noting its primary focus on developing a consensus around a proposed model for the future of the country’s regulation of medicines and medical devices following its departure from the EU.

Categories: News, Europe, EC, EMA, MHRA, NICE, Drugs, Government affairs, Medical Devices

Tags: UK MHRA business plan, UK medical devices, pharmaceutical regulations

FDA Identifies More Than 70 Class I Devices Now Exempt From 510(k) Requirements By Zachary Brennan - Published 12 April 2017

As part of its implementation of the 21st Century Cures Act, the US Food and Drug Administration (FDA) on Wednesday released a list of more than 70 Class I medical devices that are now exempt from premarket notification requirements.

Categories: News, US, FDA, Government affairs, In vitro diagnostics, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: 21 Century Cures, Class I devices, medical devices

IMDRF Offers New Guideline on Adverse Event Reporting By Zachary Brennan - Published 10 April 2017

As a way to improve the accuracy and capture of medical device adverse events, the International Medical Device Regulators Forum (IMDRF), a voluntary and global group of device regulators, on Monday published a new final guideline on a harmonized terminology for reporting such events.

Categories: News, Asia, Canada, Europe, US, IMDRF, Compliance, In vitro diagnostics, Medical Devices, Postmarket surveillance, Quality

Tags: adverse events for medical devices, IMDRF guideline, GHTF

MDR and IVDR: the Potential for a 28-Agency, 22-Language Regulatory Process for Medical Devices in the EU By Rod Ruston - Published 03 March 2017

This article provides detail in the MDR and IVDR which seems to have escaped observation. Yet, the detail could have far-reaching implications. What follows is in both the MDR and IVDR, and so in the pursuit of clarity, all references are restricted to the MDR.

Categories: Features, Europe, EC, In vitro diagnostics, Medical Devices, Submission and registration

Tags: Medical Device Regulation, In Vitro Diagnostic Medical Devices Regulation, MDR, IVDR

Industry Argues Against FDA Home-Use Device Label Database By Michael Mezher - Published 27 January 2017

The Advanced Medical Technology Association (AdvaMed) is at odds with a recent proposal by the US Food and Drug Administration (FDA) to create a public facing electronic database for home-use medical device labels.

Categories: News, US, FDA, Labeling, Medical Devices

Tags: AdvaMed, Home-use medical devices

Outgoing FDA Commissioner Califf on Benefit-Risk Assessments and Advisory Committees By Zachary Brennan - Published 20 January 2017

Writing in JAMA and FDA’s Voice blog late this week, outgoing US Food and Drug Administration (FDA) commissioner Robert Califf took to task any doubters on the necessity of an independent FDA that can assess an investigational drug’s safety and efficacy.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, In vitro diagnostics, Medical Devices

Tags: Rob Califf, FDA commissioner, benefit-risk assessments, pharmaceuticals, medical devices

CDRH Lays Out Guidance Plans for FY 2017 By Zachary Brennan - Published 22 December 2016

The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on Thursday released a list of 12 final guidance documents and four draft guidances that it will make a priority to publish in FY 2017.

Categories: News, US, CDRH, Clinical, In vitro diagnostics, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: CDRH, draft guidance for medical devices, device manufacturer guidance from FDA

FDA to Issue More Guidance on 3D Printing By Zachary Brennan - Published 21 December 2016

As manufacturers use 3D printing to create devices matched to a patient’s anatomy and devices with complex internal structures, the US Food and Drug Administration (FDA) is working with universities, researchers and industry to further understand these products and issue more guidance.

Categories: News, US, FDA, Drugs, Government affairs, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: 3D printing, FDA regulations on 3D printing, 3D printed medical devices

International Medical Device Regulatory Update: News and Views From San Jose By Randolph Fillmore - Published 20 December 2016

Several sessions at the 2016 RAPS Regulatory Convergence, held in San Jose, California in September, focused on medical device regulations and regulatory changes worldwide. These included: FDA's establishment of a national evaluation system for medical devices, China's agreement to give imported medical devices the same treatment as those manufactured or developed domestically, Japan's reduced review time for medical devices over six years, Asia/Pacific's expected medical device market expansion and Mexico's increase in device submissions.

Categories: Features, Asia, Latin America and Caribbean, US, FDA, PMDA, Medical Devices, Submission and registration

Tags: National Evaluation System for Medical Devices, NEST, Precision Medicine, COFEPRIS

NICE Joins FDA Program to Shorten Time Between Device Approval and Insurer Coverage By Zachary Brennan - Published 15 December 2016

The UK’s National Institute for Health and Care Excellence (NICE) on Wednesday announced that it would participate in the US Food and Drug Administration’s (FDA) Payer Communication Task Force (PCTF) to help speed patients’ access to new medical devices, diagnostics and other health-related technologies.

Categories: News, Europe, US, CDRH, NICE, Due Diligence, Government affairs, Medical Devices, Regulatory intelligence, Regulatory strategy, Reimbursement

Tags: NICE, medical device insurer coverage, medical devices and approval

How to Mitigate Cross-Contamination During Colonoscopies, Final FDA Guidance Explains By Zachary Brennan - Published 29 November 2016

During a colonoscopy or esophagogastroduodenoscopy (EGD), clinicians often use an irrigation system but typically do not clean and sterilize all components of the system after each procedure, so the US Food and Drug Administration (FDA) on Tuesday issued guidance highlighting the risks of cross-contamination posed by specific practices and types of irrigation valves and accessories.

Categories: News, US, CDRH, Compliance, Crisis management, Government affairs, Medical Devices

Tags: colonoscopy, cross-contamination of medical devices, medical device safety, device irrigation systems

Asia Regulatory Roundup: TGA Consults on Accelerated Assessments for Devices (22 November 2016) By Nick Paul Taylor - Published 22 November 2016

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.

Categories: News, Asia, CDSCO, TGA, Biologics and biotechnology, Drugs, Medical Devices

Tags: Asia Regulatory Roundup, accelerate assessments medical devices