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FDA Offers Draft Guidance on Organ Preservation Device Animal Studies By Zachary Brennan - Published 15 September 2017

As the national organ transplant waiting list continues to grow and donation and transplant rates remain stagnant, the US Food and Drug Administration (FDA) on Thursday released new draft guidance to help industry with recommendations on best practices for animal studies used to evaluate organ preservation devices.

Categories: News, US, CDRH, Clinical, Medical Devices

Tags: organ preservation, FDA draft guidance

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

CDRH to Launch 'Critical to Quality' Pilot Program By Zachary Brennan - Published 11 September 2017

The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) will lead a pilot program to define characteristics of a device that are critical to product quality and how these characteristics are controlled in design and manufacturing prior to the postmarket inspection.

Categories: News, US, CDRH, Medical Devices

Tags: Critical to Quality, FDA pilot program

CDRH Releases 8 Warning Letters for Foreign, US Device Manufacturers By Zachary Brennan - Published 06 September 2017

About a week after the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) was criticized for sending a historically low number of warning letters so far in 2017, a flood of new letters were released Wednesday.

Categories: News, Asia, Europe, US, CDRH, Manufacturing, Medical Devices

Tags: warning letters, medical device warnings

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

Procedures for Device Advisory Committee Meetings: FDA Finalizes Guidance By Zachary Brennan - Published 31 August 2017

The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on Thursday finalized guidance from 2015 on advisory committee meetings.

Categories: News, US, CDRH, Compliance, Due Diligence, Government affairs, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: medical device advisory committee meetings

Early Feasibility Studies for Devices: FDA Highlights Success From Pilot By Michael Mezher - Published 30 August 2017

In a paper published in the Journal of Vascular and Interventional Radiology last week, two officials from the US Food and Drug Administration (FDA) say that the agency's early feasibility study (EFS) program helped optimize the development of a new type of catheter designed to prevent pulmonary embolisms.

Categories: News, US, CDRH, Clinical, Medical Devices, Submission and registration

Tags: Early Feasibility Study, EFS, EFS Program, Angel Catheter

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

Apple Continues Push Into Device Industry With New Patent Filing By Zachary Brennan - Published 14 August 2017

Last week, tech behemoth Apple signaled its interest in further pursuing the development of medical devices with a new patent granted for an electronic device that "computes health data."

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

Tags: Apple, iPhone, mHealth, digital health

Qualifying Medical Device Development Tools: FDA Finalizes 2013 Guidance By Zachary Brennan - Published 09 August 2017

The US Food and Drug Administration (FDA) on Wednesday finalized guidance first drafted in 2013 to formalize a program that qualifies medical device development tools (MDDT) for use in device development and evaluation programs.

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

Tags: MDDT, medical device development tools, FDA guidance

FDA Updates on Digital Health Plans, Software Pre-Certification Pilot By Michael Mezher - Published 27 July 2017

The US Food and Drug Administration (FDA) on Thursday released new details on its plans for regulating digital health technologies, including more information about its upcoming pilot program to pre-certify software-based medical devices.

Categories: News, US, CDRH, Medical Devices, Submission and registration

Tags: Pre-Certification, PreCert Pilot, Software as a Medical Device, SaMD, Digital Health

FDA: Lead Test Company May Have Violated Federal Law By Michael Mezher - Published 13 July 2017

The US Food and Drug Administration (FDA) on Thursday said that lead test maker Magellan Diagnostics may have violated federal law in its handling of customer complaints and design validation for its LeadCare testing systems.

Categories: News, US, CDRH, In vitro diagnostics

Tags: LeadCare, Lead Testing, Magellan Diagnostics, Form 483

FDA, NCI to Collaborate Further on Cancer Research By Zachary Brennan - Published 26 June 2017

The US Food and Drug Administration (FDA) and National Cancer Institute (NCI) on Monday unveiled a memorandum of understanding (MOU) to further cooperate on understanding the molecular biology of cancer as it relates to diagnostic measurements, product development and treatment.

Categories: News, US, CDRH, Combination products, Drugs, Government affairs, In vitro diagnostics, Medical Devices

Tags: National Cancer Institute, proteogenomics, cancer research

FDA Used Real-World Evidence in Heart Valve Approval By Michael Mezher - Published 14 June 2017

The US Food and Drug Administration (FDA) says it relied on real-world evidence in its decision to expand the use of Edwards Lifesciences' Sapien 3 transcatheter aortic valve replacement (TAVR) to valve-in-valve procedures.

Categories: News, US, CDRH, Medical Devices, Submission and registration

Tags: Sapien 3, Edwards Lifesciences, Real-World Evidence

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)

Navigating the Medical Device User Fee Act (MDUFA) By Denise Gottfried MS, MBA, RAC, Patricia Maguire, PhD, Angeline Chooi, Adam Eldridge, PhD, Jonathan Gottfried, MBA - Published 25 May 2017

This article examines the benefits for both FDA and the medical device industry derived from "user fees" authorized by the passage of the Medical Device User Fee Act (MDUFA 2002) and its subsequent reauthorizations.

Categories: Features, US, CDRH, Medical Devices, Submission and registration

Tags: MDUFA, Medical Device User Fee Act, 510(k), PMA, User Fees

FDA, Industry Look for Gaps in Cybersecurity By Michael Mezher - Published 18 May 2017

The US Food and Drug Administration (FDA) on Thursday kicked off a fortuitously-timed public workshop on medical device cybersecurity, the agency's third on the subject to date.

Categories: News, US, CDRH, Medical Devices

Tags: Cybersecurity, WannaCry

FDA Warns of False Results With Common Lead Test By Michael Mezher - Published 17 May 2017

In the wake of a lead contamination crisis affecting cities across the country, the US Food and Drug Administration (FDA) on Wednesday warned that a commonly used line of lead testing systems may provide falsely low results under certain circumstances.

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

Tags: Lead, Magellan Diagnostics, LeadCare

BD, Roche Weigh FDA’s Proposed Exemptions for Class II Devices By Zachary Brennan - Published 15 May 2017

Beckton, Dickinson and Co. (BD) and Roche Diagnostics are seeking clarifications and changes to the US Food and Drug Administration’s (FDA) proposed list of Class II medical devices to be exempted from premarket notification.

Categories: News, US, CDRH, Business and Leadership, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: Roche Diagnostics, BD, Class II exemptions, 21st Century Cures Act

FDA Signs Off on New Device to Treat Esophageal Birth Defect in Babies By Zachary Brennan - Published 12 May 2017

The US Food and Drug Administration (FDA) on Friday authorized the use of a first-of-its-kind medical device to treat infants up to one year old for a rare birth defect that causes a gap in their esophagus.

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

Tags: humanitarian device exemption, FDA device approvals

FDA Warns Lonza’s Class II Device Manufacturing Site By Zachary Brennan - Published 09 May 2017

The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent 21 April to Lonza’s contract manufacturing site for Class II devices in Walkersville, MD.

Categories: News, US, CDRH, Biologics and biotechnology, Compliance, Crisis management, Manufacturing, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: Lonza, medical device manufacturing, FDA warning letter

FDA to Create Digital Health Unit By Zachary Brennan - Published 04 May 2017

With ongoing work on guidance related to software as a medical device, and a new dedicated unit to digital health coming to the US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH), the agency is slowly but surely dipping its toe into the rapidly advancing field.

Categories: News, US, CDRH, Medical Devices

Tags: digital health, software as a medical device, cybersecurity

CDRH Plots Path to New 'Progressive' Approvals for Some Devices By Zachary Brennan - Published 03 May 2017

With a focus on how the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) can further use real-world evidence to inform its decision making, the center is considering "progressive" approvals whereby if a device comes to market in the EU before the US, it could also come to market in the US as long as additional postmarket data is submitted.

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

Tags: NEST, MDUFA IV, progressive approvals, breakthrough devices

House Committee Considers Four Device Bills to Add to User Fee Reauthorization By Zachary Brennan - Published 02 May 2017

The House Energy & Commerce Committee on Tuesday discussed four bipartisan bills likely to be added to the user fee reauthorization package that aim to improve the US Food and Drug Administration’s (FDA) regulation of medical devices and inspections of device manufacturing sites.

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

Tags: medical device inspections, FDA inspections, hearing aids, OTC hearing aids, MITA, AdvaMed, contrast agents

BIO, AdvaMed Seek to Tweak FDA’s New Pre-Request Draft Guidance for Combo Products By Zachary Brennan - Published 17 April 2017

Industry groups BIO and AdvaMed are seeking some changes to the US Food and Drug Administration’s (FDA) guidance on requesting informal input on combination product designations.

Categories: News, US, CBER, CDER, CDRH, Biologics and biotechnology, Combination products, Drugs, In vitro diagnostics, Medical Devices, Quality, Regulatory intelligence, Regulatory strategy

Tags: BIO, AdvaMed, combination product guidance, pre-RFD program