FDA updates guidance on identifying and responding to deficiencies

Kathryn Burke, Emergo Group

The FDA has revised the guidance document Developing and Responding to Deficiencies in Accordance with the Least Burdensome Provisions to update the considerations on identifying and responding to deficiencies in premarket submissions. The document supersedes the one of the same title issued on Nov. 2, 2000.

The revised document further clarifies the content and format of a deficiency letter and includes a new list of examples of deficiencies and applicant responses.

Guidance on requesting additional information for market registration

The FDA has finalized the guidance document​ to help agency staff develop requests for additional information needed to make a decision on a medical device marketing application. Requests for additional information for medical device marketing applications are known as deficiencies. The guidance also recommends the most efficient formats for agency and industry to send or reply to such deficienc…

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FDA’s breakthrough medical device designations tally nears 700

Stewart Eisenhart, Emergo Group

The US Food and Drug Administration has granted almost 700 designations over the past seven years under a voluntary program for expedited regulatory review of medical devices and combination products that facilitate more effective treatment or diagnosis of serious diseases.

According to recent metrics published by FDA, the agency has issued a total of 693 designations under its Breakthrough Devices Program, previously known as the Expedited Access Pathway (EAP). As of June 30, 2022, the bulk of these designations (687) have come through FDA’s Center for Devices and Radiological Health (CDRH), while the Center for Biologics Evaluation and Research (CBER) has granted another six such designations.

Although nearly 700 devices have been granted breakthrough designation, only 54 of these devices have obtained full US marketing authorizations.

Breakthrough designations gaining pace in recent years

FDA data shows that the …

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FDA releases notification requirements to protect medical device supply chains

By Stewart Eisenhart, Emergo Group

The FDA has published new guidance on reporting and notification requirements to better mitigate supply disruptions when medical device manufacturers cease or suspend production during public health emergencies.

Get the full story here at the Emergo Group’s blog.

The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MedicalDesignandOutsourcing.com or its employees.

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FDA targets oversight of 3D printed medical devices in point-of-care

By Stewart Eisenhart, Emergo Group

A new discussion paper from the US Food and Drug Administration identifies challenges to developing effective regulatory oversight of 3D printed medical devices used in patient point of care (PoC) settings, and lays out potential regulatory approaches for such devices.

Get the full story here at the Emergo Group’s blog.

The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MedicalDesignandOutsourcing.com or its employees.

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FDA medical device user fees to increase 2.5% in 2022

By Stewart Eisenhart, Emergo Group

The U.S. Food and Drug Administration has set a 2.5% increase for 2022 fiscal year fees charged to medical device market applicants seeking 510(k) clearance, Premarket Approval (PMA), De Novo or other registrations in order to sell their products on the US market.

Get the full story here at the Emergo Group’s blog.

The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MedicalDesignandOutsourcing.com or its employees.

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EU issues MDR factsheet for Class I medical device manufacturers

By Stewart Eisenhart, Emergo Group

The European Commission has published a new factsheet explaining how the upcoming Medical Devices Regulation (EU) 2017/745 (MDR) will affect manufacturers of low-risk Class I medical devices.

Get the full story here at the Emergo Group’s blog.

The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MedicalDesignandOutsourcing.com or its employees.

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TFDA announces new medical device regulations and fees

By Timothy Herr, Emergo Group

Following up on our earlier post providing details on Taiwan’s new medical device regulations, the following is a summary of noteworthy details that have subsequently become available. These are compiled from various announcements and guidance documents (all links in Chinese) published by the Taiwan Food and Drug Administration (TFDA). Unless otherwise specified, these changes will go into effect with the law on May 1. One of the key documents included in this roundup is a draft fee schedule.

Get the full story here at the Emergo Group’s blog.

The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.

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EU commission clarifies medical device standards development guidance

By Stewart Eisenhart, Emergo Group

The European Commission’s Medical Device Coordinating Group (MDCG) has issued new guidance explaining the role of safety and performance standards under current Medical Device Directives as well as the upcoming Medical Devices Regulation (MDR) and In-vitro Medical Devices Directive (IVDR).

Get the full story here at the Emergo Group’s blog.

The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.

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Survey shows solid medical device industry performance despite pandemic

By Stewart Eisenhart, Emergo Group

Medical device and IVD manufacturers report healthy performance over the course of 2020, but also faced significant operational and regulatory challenges related to the coronavirus pandemic.

Get the full story here at the Emergo Group’s blog.

The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MedicalDesignandOutsourcing.com or its employees.

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What is the latest on FDA emergency use authorizations?

FDA has 26 active guidance documents related to special recommendations for medical devices during the COVID-19-associated public health emergency.

Medical device types covered include personal protective equipment (gloves, masks, etc.), certain remote assessment and monitoring devices, ventilators, sterilizers, disinfectants, infusion pumps, thermometers and telethermographic systems, digital health devices for treating psychiatric disorders, and diagnostic tests for COVID-19.

The EUA route is intended to provide an expedited route to the US market for devices that could help address the public health emergency. The FDA has not published specific timeframe expectations for these applications, and in Emergo’s experience, the time to authorization is highly variable, and has generally increased with the duration of the public health emergency.

Get the full story on Emergo’s website.

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EU regulators issue new considerations on custom-made medical devices

By Stewart Eisenhart, Emergo Group

The European Medical Device Coordination Group (MDCG) has issued a new document covering key questions and considerations regarding custom-made medical devices in the context of Medical Devices Regulation (MDR) compliance.

Get the full story here at the Emergo Group’s blog.

The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MedicalDesignandOutsourcing.com or its employees.

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Understanding clinical evidence requirements under European Medical Devices Regulation

By Dietmar Falke, Emergo Group

The European Medical Devices Regulation (MDR) demands that “confirmation of conformity with relevant general safety and performance requirements under the normal conditions of the intended use of the device, and the evaluation of the undesirable side-effects and of the acceptability of the benefit-risk-ratio, shall be based on clinical data providing sufficient clinical evidence.”

Get the full story here at the Emergo Group’s blog.

The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MedicalDesignandOutsourcing.com or its employees.

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