Cassie Scherer

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CDRH Schedules Next Generation Sequencing Workshops

CDRH has scheduled two next generation sequencing (NGS) workshops on November 12 and 13, 2015 (see here and here for the Federal Register announcements) to further advance the conversation with stakeholders on the Agency’s development of new regulatory strategies for NGS-based clinical tests.  These workshops will build upon a discussion paper published in December 2014, … Continue Reading

Multistakeholder Group Seeks Comment on Draft Framework for IoT Device Manufactures

Last week, our colleague Libbie Canter published a post on a draft framework for Internet of Things (IoT) device manufacturers.  This post describes the Online Trust Alliance’s draft framework for best practices for IoT manufacturers and developers, such as connected home devices and wearable fitness and health technologies.  The OTA is seeking comments on its draft framework … Continue Reading

Bill Introduced to Streamline and Clarify Combination Product Regulatory Process

Sen. Johnny Isakson (R-Ga.) introduced a bi-partisan bill (S. 1767) on July 15, 2015, to help streamline and clarify the FDA regulatory process for combination products.  Co-sponsored by Sens. Robert Casey (D-Pa.) and Pat Roberts (R-Kan.), the “Combination Product Regulatory Fairness Act of 2015” is, according to Roberts, intended to “clarify the regulatory process for … Continue Reading

21st Century Cures Act Passes the House: Contains Key Provisions Related to Medical Devices

The 21st Century Cures Act (“the Act”) was passed by the U.S. House of Representatives on July 10, 2015, by a vote of 344-77. The Act includes provisions that would significantly affect the regulation of pharmaceuticals, biological products, and medical devices. We previously summarized the medical device provisions of a discussion draft of the Act … Continue Reading

FDA is Examining Device Risk Assessments in Postmarket Settings

On March 19, 2015, FDA published a public workshop notice entitled “An Interactive Discussion on the Clinical Considerations of Risk in the Postmarket Environment.” This meeting is being held on April 21 in order for FDA to further engage with the medical device industry on “assessing changes in medical device risk as quality and safety situations arise … Continue Reading

21st Century Cures Discussion Draft Act Proposes Changes to Medical Device Regulation

A discussion draft of the highly anticipated legislation, the 21st Century Cures Act, was released on January 27, 2015 (Draft Act). The Draft Act includes proposals that stem from the 21st Century Cures Initiative that was launched in April 2014 by House Energy and Commerce (E&C) Committee. The Draft Act contains five titles that are … Continue Reading

FDA Publishes Draft Guidances Describing General Wellness Claims and Risk-Based Classification of Accessories

FDA published two much anticipated draft guidances on January 16, 2015, which outline the Center for Devices and Radiological Health’s (CDRH) policy regarding low risk general wellness products and regulation of medical device accessories.  Although not solely focused on software, these guidances provide further clarification to the rapidly developing and expanding mobile app and software … Continue Reading

FDA Finalizes Appeals Guidance on Section 517A

On July 30, 2014, FDA issued a final guidance, “Center for Devices and Radiological Health Appeals Processes:  Questions and Answers About 517A,” which provides an interpretation of key terms for appeals of certain CDRH decisions under section 517A of the Food, Drug, and Cosmetic Act (FDCA), including what constitutes a “significant decision” and a “substantive … Continue Reading

FDA Finalizes Guidance on the Evaluation of 510(k) Substantial Equivalence

On July 28, 2014, FDA issued an important final guidance relating to the Agency’s substantive review of 510(k) notifications, entitled “The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)].”  This guidance applies to the 510(k) review process for both diagnostic and therapeutic devices and is applicable to 510(k) reviews undertaken by the Center for … Continue Reading

FDA Issues Draft Guidance on Benefit-Risk Considerations

On July 15, 2014, FDA issued a draft guidance entitled “Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications [510(k)] with Different Technological Characteristics,” which describes the benefit and risk factors that FDA may consider during the review process for a 510(k) submission (“draft guidance”).  This draft guidance applies to both diagnostic and … Continue Reading

FDA Relaxes Regulation of Certain Software Devices

On June 20, 2014, FDA issued a draft guidance entitled “Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices,” informing manufacturers and others “that the Agency does not intend to enforce compliance with the regulatory controls” that apply to these three types of devices. Medical device data systems (MDDS), medical image … Continue Reading

FDA Issues Draft Guidance on a Proposed Expedited Access Program for Medical Devices Intended for Unmet Medical Needs

On April 23, 2014, FDA announced the availability of a draft guidance that describes FDA’s proposal for a new, voluntary program designed to expedite patient access to certain medical devices that are intended for unmet medical needs and are subject to premarket approval (PMA) applications. The proposed program entitled “Expedited Access PMA for Unmet Medical … Continue Reading
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