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BIO, AdvaMed Seek to Tweak FDA’s New Pre-Request Draft Guidance for Combo Products By Zachary Brennan - Published 17 April 2017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

FDA Offers its Views on Medical Device Trials By Zachary Brennan - Published 06 April 2017

Officials from the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) took to the New England Journal of Medicine on Thursday to explain the wide array of clinical trial designs and data sources that may be used to support the safety and effectiveness of medical devices.

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

Tags: CDRH, medical device trials, FDA views

FDA Approves First DTC Tests Evaluating Genetic Risk Information By Zachary Brennan - Published 06 April 2017

The US Food and Drug Administration (FDA) on Thursday authorized the first direct-to-consumer genetic health risk tests for 10 diseases and conditions.

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

Tags: 23andMe, direct to consumer genetic tests, genetic tests, Alzheimer's, Parkinson's

CDRH Seeks Participants for Staff Training Program By Zachary Brennan - Published 24 March 2017

Medical device companies and other stakeholders have until 30 April to apply to be a part of the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) Experiential Learning Program (ELP), which is meant to help agency staffers better understand medical devices. 

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

Tags: ELP, CDRH training, staff training FDA devices

CDER, CDRH and CBER Directors Stress Importance of User Fee Reauthorizations Before Senate Committee By Zachary Brennan - Published 21 March 2017

The US Senate Health, Education, Labor & Pensions Committee on Tuesday pressed three top US Food and Drug Administration (FDA) officials for details on how plans to reauthorize their user fee programs would help to further streamline medical product approvals.

Categories: News, US, CBER, CDER, CDRH, Biologics and biotechnology, Drugs, Government affairs, Medical Devices

Tags: FDA user fees, GDUFA, BsUFA, MDUFA, PDUFA, Senate HELP

FDA Drafts List of Class II Devices to be Exempt From Premarket Notification By Zachary Brennan - Published 13 March 2017

The US Food and Drug Administration (FDA) began implementing the recently passed 21st Century Cures Act on Monday by publishing a draft list of class II devices that will be exempt from premarket notification requirements, or 510(k)s.

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

Tags: Class II devices, 21st Century Cures, FD&C Act

AdvaMed Boils Down Top Priority FDA Guidance Documents for 2017 By Zachary Brennan - Published 09 March 2017

Medical device industry group AdvaMed pointed to seven guidance documents slated for release in 2017 by the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health as those that are of the highest priority to its member companies.

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

Tags: AdvaMed, device guidance, FDA guidance 2017

FDA Warns of Complications With Neurovascular Catheters By Michael Mezher - Published 01 March 2017

The US Food and Drug Administration (FDA) on Wednesday warned healthcare providers of potential harm to patients when neurovascular guide catheters are used to remove blood clots in stroke patients.

Categories: News, US, CDRH, Medical Devices, Postmarket surveillance

Tags: Neurovascular Thrombus Retrieval Catheters, Neurovascular Guide Catheters

Senators Look to Overhaul Medical Device Inspections By Michael Mezher - Published 21 February 2017

Sens. Johnny Isakson (R-GA) and Michael Bennett (D-CO) have introduced a bill that looks dramatically alter the US Food and Drug Administration's (FDA) process for inspecting device manufacturers.

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

Tags: Inspections

CDRH Warns Three Foreign Medical Device Manufacturers By Zachary Brennan - Published 07 February 2017

The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on Tuesday released three warning letters sent to medical device manufacturers in Taiwan, China and South Korea.

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

Tags: warning letters, quality data

FDA Finalizes Guidance on Benefit-Risk Considerations for IDEs By Michael Mezher - Published 12 January 2017

The US Food and Drug Administration (FDA) on Thursday finalized its guidance detailing its framework for assessing the benefits and risks of investigational device exemptions (IDEs).

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

Tags: Investigational Device Exemption, Final Guidance

Mammogram Record Retention: FDA Offers Advice By Zachary Brennan - Published 05 January 2017

Following some confusion over mammogram record retention requirements, the US Food and Drug Administration (FDA) on Thursday told all facilities conducting such tests that they must retain a record of each one for at least five years, or not less than 10 years if no additional mammograms of the patient are performed at the facility (or a longer period if mandated by state or local law).

Categories: News, US, CDRH, Crisis management, Medical Devices, Quality, Regulatory intelligence

Tags: mammogram, FDA and mammography, MQSA

CDRH Speeds Release of Device Recall Information By Zachary Brennan - Published 03 January 2017

The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on Tuesday began posting medical device recall information in a searchable database much earlier than the agency ever has before.

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

Tags: device recalls, FDA recalls, recall coordinators

FDA Finalizes Postmarket Cybersecurity Guidance By Michael Mezher - Published 03 January 2017

Just before the close of 2016, the US Food and Drug Administration (FDA) finalized its guidance for managing postmarket cybersecurity for connected medical devices.

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

Tags: Cybersecurity, Medical Device Cybersecurity

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

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

FDA to Publicly Disclose ‘Emerging Signals’ Info for Medical Devices By Zachary Brennan - Published 13 December 2016

The public will soon see more prompt notifications on medical device risks and potential risks thanks to guidance finalized Tuesday by the US Food and Drug Administration (FDA).

Categories: News, US, CDRH, Compliance, Crisis management, Ethics, Medical Devices, Regulatory intelligence, Submission and registration

Tags: emerging signals, medical device risks, medical device data, FDA publishing medical device data

Medical Device Performance Goals: FDA Offers a Quarterly Update By Zachary Brennan - Published 09 December 2016

The US Food and Drug Administration (FDA) on Friday released its latest performance data, revealing that the number of premarket applications (PMAs) for devices with a major deficiency letter on the first FDA review cycle is up to its highest level ever, and up more than 25% since 2015.

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

Tags: 510(k), PMA, FDA approval of medical device, devices substantially equivalent

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

FDA Delays Finalization of Lab-Developed Test Draft Guidance By Zachary Brennan - Published 18 November 2016

The US Food and Drug Administration (FDA) on Friday said it will wait for the new administration and halt the finalization of guidance that would have changed the way lab-developed tests (LDTs) are regulated.

Categories: News, US, CDRH, Government affairs, In vitro diagnostics

Tags: LDTs, lab-developed tests, in vitro diagnostics

Lead MDUFA Negotiator Details Changes in MDUFA IV Financing By Michael Mezher - Published 02 November 2016

The US Food and Drug Administration's (FDA) top negotiator for the fourth iteration of the Medical Device User Fee Act (MDUFA IV) presented changes to the funding mechanisms of the program at a public meeting at FDA's White Oak Campus on Wednesday.

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

Tags: MDUFA IV, Medical Device User Fee Act

FDA Approves First PFO Occluder From St. Jude By Zachary Brennan - Published 28 October 2016

The US Food and Drug Administration (FDA) on Friday approved Minnesota-based St. Jude Medical’s Amplatzer PFO Occluder, which is intended to reduce the risk of a stroke for some patients who previously had a stroke.

Categories: News, US, CDRH, Medical Devices, Regulatory intelligence, Regulatory strategy, Research and development

Tags: PFO Occluder, St. Jude Medical, FDA device approval

Regulatory Misconduct: FDA Launches Website for Allegations Against Device Manufacturers By Zachary Brennan - Published 24 October 2016

A little more than a week after a scathing report in the Minneapolis Star-Tribune revealed the US Food and Drug Administration (FDA) has accepted late adverse event reports from device companies for hundreds of thousands of incidents, and the agency on Monday launched a new website for regulatory misconduct allegations.

Categories: News, US, CDRH, Compliance, Crisis management, Ethics, Medical Devices

Tags: regulatory misconduct, medical device companies and adverse events, misconduct and FDA

FDA Targets 15 Hospitals Over Significant Deviations from Medical Device Reporting Regulation By Zachary Brennan - Published 24 October 2016

The US Food and Drug Administration (FDA) on Monday released a summary of hospital inspection findings, as well as Form 483s for 15 hospitals, detailing the hospitals' failures to report medical device-related adverse events in a timely manner.

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

Tags: medical device adverse events, FDA inspections of hospitals, patient deaths from medical devices

FDA Amends Definition of Custom Device By Zachary Brennan - Published 11 October 2016

The Food and Drug Administration (FDA) on Tuesday released a final rule that amends its regulations on the definition of a custom device so as to include new statutory requirements under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA).

Categories: News, US, CDRH, Compliance, Government affairs, Medical Devices, Product withdrawl and retirement, Project management, Quality

Tags: custom medical device, device regulations, premarket notification, FDA final rule