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FDA Discusses Device Least Burdensome Provisions in New Draft Guidance By Michael Mezher - Published 14 December 2017

After signaling that it would shift more of the regulatory oversight of medical devices to the postmarket setting, the US Food and Drug Administration (FDA) on Thursday issued a new draft guidance detailing updates to its least burdensome approach to regulating devices.

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

Tags: Least Burdensome, FDASIA, 21st Century Cures, Alternative 510(k) Pathway

CDRH Sees Spike in Pre-Market Submissions With Patient-Reported Outcome Measures By Zachary Brennan - Published 12 December 2017

The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on Tuesday issued its first report on patient-reported outcomes (PROs), noting a significant uptick in PRO data submitted in 2017.

Categories: News, CDRH, Clinical, In vitro diagnostics, Medical Devices, Postmarket surveillance

Tags: patient-reported outcomes, medical device submissions

What New CDRH Guidance is Coming in FY 2018: Alternative 510(k) Pathway and More By Zachary Brennan - Published 11 December 2017

While recognizing that comparison testing for 510(k) applicants can be outdated, especially for newer medical devices, the US Food and Drug Administration (FDA) announced Monday that in the first quarter of 2018, new draft guidance will be released to address an alternative pathway for demonstrating substantial equivalence.

Categories: News, US, CDRH, Government affairs, In vitro diagnostics, Medical Devices, Research and development

Tags: CDRH guidance, 510(k) alternative pathway, PMA

FDA Warns California Device Company for Failing to Disclose Serious Injury By Zachary Brennan - Published 05 December 2017

The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent last month to Sacramento, California-based Hand Biomechanics Lab after the firm failed to submit a report to the agency of a serious injury that may have been caused by one of the company’s medical devices.

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

Tags: warning letter, device injury

Journal Editors Should Encourage Disclosures of CDRH's Role in Trial Designs: JAMA Viewpoint By Zachary Brennan - Published 07 November 2017

Journal editors should encourage research authors to disclose the role of the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) in clinical trial design and execution, Aaron Kaplan of the Heart & Vascular Center at Dartmouth-Hitchcock Medical Center and Ariel Stern of Harvard Business School, wrote in a JAMA viewpoint.

Categories: News, US, CDRH, Government affairs, Medical Devices

Tags: medical device clinical trials,

Needle Destruction Devices: FDA Proposes Reclassification By Zachary Brennan - Published 06 November 2017

The Food and Drug Administration (FDA) on Monday proposed reclassifying the needle destruction device, renamed as "sharps needle destruction device," from a Class III device into Class II (special controls), subject to premarket notification.

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

Tags: needle destruction device, sharps needle destruction

De Novo Classifications: FDA Drafts Guidance on Acceptance Reviews, Finalizes Guidance From 2014 By Zachary Brennan - Published 27 October 2017

Following the creation of a new De Novo classification request user fee under the fourth iteration of the Medical Device User Fee Amendments (MDUFA IV) of $93,017 (small businesses pay $23,254), the US Food and Drug Administration (FDA) on Friday released one final guidance and one draft guidance.

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

Tags: de novo request, FDA guidance, de novo device

FDA Warns Lead-Testing Diagnostics Company By Zachary Brennan - Published 23 October 2017

The US Food and Drug Administration (FDA) on Monday sent a warning letter to Massachusetts-based Magellan Diagnostics, a subsidiary of Meridian Bioscience, finding the company made significant changes to its lead-testing devices without notifying the agency, among other violations.

Categories: News, US, CDRH, Due Diligence, Medical Devices, Quality

Tags: lead tests, Magellan Diagnostics, Meridian Bioscience

FDA Warns Swedish IVD Manufacturer By Zachary Brennan - Published 10 October 2017

The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent 20 September to Malmo, Sweden-based Euro Diagnostica AB, which manufactures multiple class II in vitro diagnostic (IVD) devices.

Categories: News, Europe, US, CDRH, Compliance, Due Diligence, In vitro diagnostics, Medical Devices, Quality

Tags: FDA warning letters, IVD manufacturer warning letter, Euro Diagnostica

Building NEST: New Executive Director, CDRH's Shuren Discuss Plans By Zachary Brennan - Published 27 September 2017

The group of stakeholders building the National Evaluation System for health Technology (NEST) outlined what’s in store for the new future as well as the direction that they want the system to go.

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

Tags: NEST, real world data, Jeff Shuren

CDRH Plots Creation of New 'Super Office,' Alternative 510(k) Pathway By Zachary Brennan - Published 27 September 2017

Jeff Shuren, director of the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) told attendees at the final session at AdvaMed’s MedTech conference in San Jose, California, that his center is plotting the creation of a new "super office."

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

Tags: postapproval, 510(k) pathway, medical device approvals, total product life cycle super office

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

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

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

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