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FDA Releases Draft Guidance: Content of Premarket Submissions for Device Software Functions

In step with the U.S. Food and Drug Administration’s (FDA) commitment to develop a draft revised version of “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices” (2005), the agency, on November 3, 2021, has issued draft guidance—“Content of Premarket Submissions for Device Software Functions.”   

NAMSA First to Receive FDA ASCA Accreditation for Medical Device Biocompatibility Testing

Medical device and diagnostic manufacturers seeking acceleration of U.S. Food and Drug Administration (FDA) approval may benefit from one of two purpose-built FDA programs: 1) the Breakthrough Devices Program; and 2) the Safer Technologies Program (STeP). The benefits of these programs are substantial for manufacturers who apply, qualify and are granted designation by FDA.

FDA Breakthrough Devices and Safer Technologies Programs: Advantages for Patients and Medical Device Manufacturers

Medical device and diagnostic manufacturers seeking acceleration of U.S. Food and Drug Administration (FDA) approval may benefit from one of two purpose-built FDA programs: 1) the Breakthrough Devices Program; and 2) the Safer Technologies Program (STeP). The benefits of these programs are substantial for manufacturers who apply, qualify and are granted designation by FDA.

Star Tribune Interview with CEO, Christophe Berthoux: NAMSA in Growth Mode under New Leadership

NAMSA, the Ohio-based medical device testing and consulting firm with a long history in the Twin Cities, is ratcheting up its deal-making following a transaction last year that put the company in new hands.

FDA Qualifies New Cybersecurity Medical Device Development Tool

On October 20, 2020, the U.S. Food and Drug Administration’s (FDA) Medical Device Development Tools (MDDT) Program announced the qualification of a new tool for medical device development within cybersecurity risk evaluations.

FDA CDRH Announces New Resource for Medical Device Biocompatibility Assessments 

The U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) announced on March 18 that it is now offering  an electronic Biocompatibility Assessment Resource Center intended to provide guidance for addressing and evaluating the biocompatibility of medical devices. 

Effective March 15: CMS Rule Regarding Medicare Coverage of Innovative Technology (MCIT) and Definition of ‘Reasonable and Necessary’

On January 14, 2021, the Centers for Medicare & Medicaid Services (CMS) released the Final Rule, “Medicare Program; Medicare Coverage of Innovative Technology (MCIT) and Definition of ‘Reasonable and Necessary.” As part of Medicare’s Patients over Paperwork initiative, This final rule regulates how the largest U.S. federal payer will reimburse for innovative technologies, beginning March 15, 2021.

U.S. FDA Releases Artificial Intelligence and Machine Learning Action Plan

In step with the U.S. Food and Drug Administration’s (FDA) commitment to develop and apply innovative approaches to the regulation of medical device software and other digital health technologies, on January 12, 2021, the Agency released their first Artificial Intelligence/Machine Learning (AI/ML) – Based Software as a Medical Device (SaMD) Action Plan.

U.S. FDA Introduces Safer Technologies Program to Promote Safe, Early Access to Innovative Medical Devices

In step with the Breakthrough Devices Program, and the Agency’s promise to introduce additional programs that promote earlier access to life-changing devices, the U.S. FDA introduced the Safer Technologies Program (“STeP”) on January 6, 2021. The FDA’s latest program is intended for 510(k), De Novo or PMA devices that do not meet Breakthrough Devices Program criteria, but still have an important role in the treatment of lesser life-threatening or debilitating diseases/conditions and bring significant benefits to patients.

CDRH COVID-19-Related Workload Impacts Q-Submission Reviews

In recent weeks, NAMSA has become aware of instances in which the U.S. Food and Drug Administration (FDA) CDRH Office has closed Q-Submissions without review, citing resource constraints stemming from the COVID-19 Pandemic. With the FDA’s commitment to protecting public health, the agency has allocated resources to focus on COVID-19-related activities, working alongside other federal, state and local agencies and officials to address the pandemic.

Industry Update: Accreditation Scheme for Conformity Assessment

As discussed in NAMSA’s December 19 blog post, “The Evolution of the Accreditation Scheme for Conformity Assessment,” ASCA is an assessment created by the U.S. Food and Drug Administration (FDA) following amendments to Section 514 by the FDA Reauthorization 95 Act of 2017 (FDARA). The assessment was initiated as part of the enactment of the Medical Device User Fee 96 Amendments of 2017 (MDUFA IV).

FDA Releases New Draft Guidance for Biocompatibility of Devices in Contact with Intact Skin

On October 15, 2020, the U.S. Federal Food and Drug Administration (FDA) released a new draft guidance, “Select Updates for Biocompatibility of Certain Devices in Contact with Intact Skin,” which is intended to add or supersede applicable sections of the 2016 biocompatibility guidance (recently updated in 2020), “Biological Evaluation of Medical Devices-Part 1: Evaluation and … Continued

Key Considerations for Executing Clinical Trials for Dual 510(k) and CLIA Waiver Applications

With the number of COVID-19 cases on the rise, and no definite end date to nationwide travel restrictions, various Contract Research Organizations (CROs) and Biotech/Pharma companies are hard at work trying to figure out how to efficiently conduct ongoing clinical trials while employees work remotely and subjects are restricted to their homes. Virtual options for clinical trials are gaining more clinical industry leader and regulator attention at this unique time in history. With the current technological resources available, Sponsors are able to conduct certain IVD clinical trials virtually with full regulatory compliance to FDA guidelines, and with several advantages.

FDA Releases Final Guidance on Bone Anchor Premarket Notification 510(k) Submissions

This week’s release of the U.S. Food and Drug Administration’s (FDA) final guidance on “Bone Anchors – Premarket Notification 510(k) Submissions” is based on the agency’s draft guidance from January 2017. While there are no significant differences between the draft document and the final guidance, the FDA did update this document to reflect other released guidance documents and minimal revisions.

U.S. FDA Announces eSTAR Pilot Program to Streamline 510(k) Submission Process

On February 27, 2020, the U.S. Food and Drug Administration (FDA) announced the launch of its new pilot program for 510(k) submission templates.

The Evolution of the Accreditation Scheme for Conformity Assessment (ASCA) for Medical Device Premarket Approval

ASCA is the Accreditation Scheme for Conformity Assessment (ASCA), which was created by the United States Food and Drug Administration (FDA) following amendments to Section 514 by the FDA Reauthorization 95 Act of 2017 (FDARA).

FDA CDRH: New Organizational Structure Effective May 1, 2019

In the fall of 2018, the U.S. Food & Drug Administration’s (FDA) Center for Medical Devices and Radiological Health (CDRH) announced the largest reorganization in years to initiate the Total Product Life Cycle (TPLC) approach across the institution (read more here). Fast forward to May 1, 2019—the date that the CDRH declared that it had … Continued

FDA Shifts 510(K) Paradigm, Announces Transformative Steps to Modernize 510(k) Program

Since May 28, 1976, the United States (U.S.) Food & Drug Administration (FDA) has had an alternative in place to the extremely burdensome Investigational Device Exemption (IDE) and Pre-Market Approval (PMA) processes to get new products onto the market, and that alternative is called the 510(k) process. By definition, “510(k) merely refers to the relevant … Continued

FDA CDRH Reorganization: Faster Reviews for Medical Device Manufacturers?

The U.S. Food & Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) is currently undergoing one of its most ambitious reorganizations in decades to initiate the Total Product Life Cycle (TPLC) approach across the organization. The TPLC methodology, which has been in place in the Office of In-vitro Diagnostics and Radiological Health (OIR) … Continued

FDA Announces FY19 User Fees

Today, the U.S. Food & Drug Administration (FDA) published its User Fees for Fiscal Year 2019 (October 1, 2018 – September 30, 2019), which includes pricing for device submissions and establishment registrations. The official notice from the FDA may be found by clicking here. The most significant changes for U.S. medical device manufacturers to consider are … Continued

Mid-Year FDA Regulation & Guidance Review

Introduction It is often difficult to stay abreast of the many regulatory changes occurring within the medical device industry, not to mention what they may mean in practice for global manufacturers. To assist with this mission, provided below is a mid-year review of noteworthy U.S. Food & Drug Administration (FDA) regulatory updates and guidance releases … Continued

FDA Issues New Draft Guidance Document for Pre-Submissions

In response to the goals set forth within the 2017 Medical Device User Fee Amendment (MDUFA IV), the U.S. Food & Drug Administration (FDA) issued on June 7, 2018, a new Draft Guidance for Pre-Submissions, intended to replace the September 29, 2017 Final Guidance. Although the Draft Guidance, “Requests for Feedback and Meetings for Medical … Continued

Obtaining Actionable FDA Feedback: How to Develop Targeted Questions for Pre-Submission Meetings

Introduction Within any industry, if you ask poor questions, you will often get poor answers. This is especially true for the medical device industry and more specifically, for product manufacturers seeking feedback from the U.S. Food & Drug Administration (FDA). Simply put, asking better questions can assist device organizations to identify and solve potential device … Continued