Search Results for 510(k)

Showing 1 – 25  of 91

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

When to Submit a 510(k) (Devices and Software): A Regulatory Perspective By Jeff Ryberg - Published 21 March 2017

This article explores key elements of the US Food and Drug Administration's (FDA's) latest draft guidance to industry for deciding when to submit a new 510(k) for medical device hardware and software design changes. The potential business impact is assessed and suggestions are provided for what companies need to do to align with FDA's current thinking.

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

Tags: 510(k), Software

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

Industry Groups Call for Clarity in New 510(k) Device Modifications Guidance By Michael Mezher - Published 14 November 2016

Prominent medical device manufacturers and industry groups are calling on the US Food and Drug Administration (FDA) to make changes to its recently released draft guidance on submitting a new 510(k) for changes to a medical device.

Categories: News, US, FDA, Labeling, Manufacturing, Medical Devices, Submission and registration

Tags: 510(k) device modifications

Common Pitfalls Associated with Modifications to 510(k)-Cleared and 510(k)-Exempt Devices By Pamela Forrest, Jessica Ringel, Lynette Zentgraft - Published 21 September 2016

This article identifies some common pitfalls companies often encounter when assessing modifications to 510(k)-cleared and 510(k)-exempt medical devices and offers approaches for performing these assessments to better ensure compliance with FDA expectations.

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

Tags: 510(k), Device Modifications

510(k) Third Party Review Program: FDA Offers New Draft Guidance By Zachary Brennan - Published 09 September 2016

The US Food and Drug Administration (FDA) on Friday issued new draft guidance updating the agency’s current thinking on a program used to accredit third parties to review premarket notification (510(k)) submissions for medical devices and recommend the initial classification of certain devices.

Categories: Canada, Europe, US, CDRH, Health Canada, IMDRF, MHLW, TGA, Government affairs, Manufacturing, Medical Devices, Research and development

Tags: 510(k) submissions, medical devices, third-party audits of medical devices, IMDRF, MDSAP

New Guidance Gives Device Makers More Leeway With 510(k)s for X-Rays By Michael Mezher - Published 02 September 2016

The US Food and Drug Administration (FDA) has issued new guidance on submitting 510(k)s for x-rays, giving device makers more leeway on the information required to demonstrate substantial equivalence to an already approved product.

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

Tags: 510(k), X-ray

FDA Issues Draft Guidance on 510(k) Device Modifications By Michael Mezher - Published 05 August 2016

The US Food and Drug Administration (FDA) on Friday released two draft guidances for public comment clarifying its policy for when manufacturers should submit a 510(k) for changes made to a medical device or its software.

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

Tags: 510(k), 510(k) Device Modification, Medical Device Software

Fundamentals and Global Impact of 510(k) for Medical Devices By Mingzi Deng, RAC, Shrenik Desai, MS, RAC, Aastha Kohli, MS, RAC, Lewis Lau, RAC, Mukesh Kumar, RAC, Marko Spaic, Dejan Ratkov, BScEE - Published 11 February 2016

This article presents an overview of the fundamentals of 510(k) submissions, including the impact of the unique regulations to US and foreign device manufacturers.

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

Tags: 510(k), Preamendment devices, Third party review, Abbreviated 510(k), Special 510(k)

FDA Releases Draft Guidance on Displays Devices for Diagnostic Radiology By Michael Mezher - Published 08 February 2016

The US Food and Drug Administration (FDA) released a new draft guidance intended to clarify the information device makers should include in their 510(k) submissions for displays used in diagnostic radiology.

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

Tags: Mammography, Display device, Radiology, 510(k)

510(k) Submissions: Current Trends and Tips By Kenneth C. Maxwell II - Published 01 February 2016

This article discusses current trends in the 510(k) submission process, primarily with Class II orthopedic and spinal implants, and will provide tips on maintaining a smooth and successful submission process.

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

Tags: 510(k), Sterilization validation, deficiencies, guidance

The 'Catch-Up' 510(k) - A Submission Often Overlooked By Meaghan Bailey, RAC, Deborah Baker-Janis - Published 26 January 2016

This article discusses "catch-up" 510(k) submissions, circumstances under which a "catch-up" 510(k) submission should be considered, content and timing of such a submission and procedural recommendations for this submission type.

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

Tags: 510(k), catch-up 510(k),

Facilities Sterilizing Devices via 'Novel' Methods Will See New FDA Inspections By Zachary Brennan - Published 20 January 2016

As medical devices are sterilized with novel and sometimes risky new methods and chemical combinations, the US Food and Drug Administration (FDA) announced Wednesday that it will begin inspecting companies' manufacturing facilities before clearing their 510(k) applications.

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

Tags: 510(k) submission, medical device FDA, device sterilization, sterilants

FDA Sees Record-High PMA Approval Rate for 2015 By Zachary Brennan - Published 11 November 2015

The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) has approved nearly every Premarket Approval Application (PMA) it received for medical devices in 2015 and the spike may be linked to FDA’s improved assessment of PMA deficiencies earlier in the review process.

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

Tags: PMA, 510(k), PMA approvals, FDA statistics, Food and Drug Administration, FDA, CDRH

Senators Introduce Two Bills to Streamline FDA Reviews of Medical Devices By Zachary Brennan - Published 22 October 2015

Sens. Cory Gardner (R-CO) and Joe Donnelly (D-IN) late Wednesday announced the introduction of two new bills that would further streamline the US Food and Drug Administration (FDA) approval process for certain medical devices.

Categories: News, US, FDA, Compliance, Medical Devices, Orphan products, Quality, Regulatory intelligence, Regulatory strategy

Tags: medical devices, FDA, rare disease, 510(k), regulatory efficiency

OpenFDA Releases Huge Trove of Medical Device Data By Michael Mezher - Published 02 September 2015

On Monday, the US Food and Drug Administration (FDA) released a vast amount of medical device data to its openFDA platform.

Categories: News, US, FDA, Communication, Government affairs, Medical Devices, Postmarket surveillance, Research and development

Tags: openFDA, device approvals, 510(k), de novo

Are You a Good Witch, or a Bad Witch? By Sharon DeGrove Bishop, RAC - Published 26 August 2015

Upon meeting Dorothy in The Wizard of Oz, Good Witch Glinda asks “Are you a good witch, or a bad witch?” As we soon learn in the film, this is a critical distinction—Glinda helps Dorothy return home to Kansas, while the Wicked Witch of the West uses every resource she has, including those terrifying flying monkeys, to capture Dorothy and her ruby slippers. We considered this question relative to the Refuse to Accept Policy for 510(k)s from the US Food and Drug Administration (FDA).

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

Tags: US Food and Drug Administration, FDA, medical device, refuse to accept policy, RTA, 510(k), premarket clearance

Eight Additional Device Classes Exempt from Premarket Notification Requirements By Michael Mezher - Published 14 August 2015

In July, the US Food and Drug Administration exempted some 120 medical device classes from its premarket notification and review requirements. Now, FDA has announced it is exempting additional device classes from these requirements, after an administrative error caused the agency to miss some comments from a public consultation.

Categories: News, US, FDA, Medical Devices

Tags: Premarket notifications, 510(k)

FDA Updates Refuse to Accept Policy for 510(k)s By Michael Mezher - Published 05 August 2015

This week, the US Food and Drug Administration (FDA) released a new guidance detailing its criteria for accepting 510(k) submissions.

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

Tags: Refuse to Accept, 510(k)

FDA to Replace 17-Year-Old Guidance for MRI Premarket Notifications By Michael Mezher - Published 14 July 2015

The US Food and Drug Administration (FDA) is seeking input as it begins to draft a new guidance intended to help makers of magnetic resonance diagnostic devices (MRDDs) complete premarket notification 510(k) applications.

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

Tags: Magnetic resonance diagnostic device, Magnetic resonance imaging, MRDD, MRI, 510(k)

FDA Exempts 120 Medical Device Types from Most Regulation By Alexander Gaffney, RAC - Published 30 June 2015

The US Food and Drug Administration (FDA) plans to exempt 120 medical device classes from its premarket notification and review requirements, making it substantially easier for companies to market the devices.

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

Tags: 510(k), Premarket Notification, Exempt, Exemption

Expedited Medical Device Submissions in the US: Special 510(k), Abbreviated 510(k), HDE By Sheila Ramerman, RAC - Published 04 March 2015

An overview of expedited pathways for US medical devices that are alternatives to Traditional 510(k)s and Premarket Approval Applications (PMAs). These include Special 510(k), Abbreviated 510(k) and Humanitarian Device Exemption (HDE) submission types.

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

Tags: expedited pathways, Traditional 510(k)s, Special 510(k)s, Abbreviated 510(k)s, Humanitarian Device Exemption, HDE, clearance

Does FDA Take Longer to Clear 510(k)s From Non-US Companies? By Sharon DeGrove Bishop, RAC - Published 19 February 2015

With respect to FDA 510(k) premarket clearances, the country where the submitter is located doesn’t have any bearing on how long it takes to get clearance from the FDA. Or does it?

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

Tags: RIQ, Regulatory Intelligence Quotient, Graematter, 510(k), Special 510(k), Traditional 510(k), Clearance, Premarket Notification

High Failure Rate for AEDs Prompts FDA Change in Regulatory Policy Published 02 February 2015

The US Food and Drug Administration's (FDA) has finalized a change in policy that will soon require all Automated External Defibrillators (AEDs) to undergo a more rigorous regulatory review process meant to ensure the devices—which have failed in tens of thousands of reported cases since 2005—function reliably when they are needed most.

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

Tags: AED, Automated External Defibrillator, PMA, 510(k), Regulation, Final Rule