Tag Archives: FDASIA

Obama Administration Will Not Finalize LDT Framework Guidance

On November 18, 2016, the U.S. Food and Drug Administration (FDA or Agency) announced that it would not finalize the draft guidance entitled Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs) (Draft Guidance) prior to the end of the Obama administration. As we previously reported, FDA issued the Draft Guidance on October 3, 2014.  … Continue Reading

FDA Issues Draft Guidance on Determining when Data from Foreign Clinical Studies Can Support Device Submissions

It is becoming increasingly common for medical device companies to conduct clinical studies outside the United States and then seek to use data from these foreign studies in regulatory submissions to FDA. In a draft guidance issued on April 22, 2015, FDA lays out the factors it considers when confronted with data from foreign studies … Continue Reading

Custom Device Exemption Remains Narrow, but FDA’s Final Guidance Addresses Industry Concern About “Device Type” Definition

FDA announced the availability of its final guidance on the “custom device exemption” on September 24, 2014 and held a webinar on this topic on October 14, 2014 (the video for this webinar can be found here and the transcript here).  The final guidance contains several changes from the draft guidance (see our blog on … Continue Reading

FDA Focuses on Sex-Specific Data in Medical Device Clinical Trials

On August 22, 2014, FDA issued a final guidance addressing the collection and analysis of sex-specific data in medical device clinical trials, entitled “Evaluation of Sex-Specific Data in Medical Device Clinical Studies.”  The guidance outlines “FDA’s expectations regarding sex-specific patient enrollment, data analysis, and reporting of study information.”  According to the guidance, studying both sexes … 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FDA Issues Draft Guidance on Custom Device Exemption

On January 14, 2014, FDA announced the availability of a draft guidance entitled “Custom Device Exemption.”  FDA requests that parties submit comments within 60 days of publication (by March 15, 2014). Custom devices are exempt from the premarket review requirements and performance standards under FDCA sections 514 and 515, but they are not exempt from … Continue Reading

Key Open Questions for FDA’s Upcoming Report on Regulation of Health IT

We’ve previously blogged about the “FDASIA Workgroup” and section 618 of the Food and Drug Administration Safety and Innovation Act (FDASIA), which directed FDA to issue a report to Congress by January of 2014 on the regulation of health technology.  This post covers some of the differing views on Health IT regulatory issues and open … Continue Reading

FDA Issues Final Unique Device Identifier Rule

On Friday, FDA released a final rule implementing a “unique device identifier” (UDI) system.  The final rule retains the basic framework and most of the key requirements of the proposed rule.  (For a summary of the proposed rule, see our July 16, 2012 client alert.)  Nevertheless, the final rule contains several important differences from the … Continue Reading

FDASIA Workgroup Releases Draft Recommendations for Regulation of Health IT

FDA’s regulation of Health IT under its medical device authorities can be seen as proceeding on two separate tracks during the last year. Track one is FDA’s ongoing policymaking.  In 2011, FDA issued a draft guidance document on mobile medical applications and a final rule on medical device data systems, setting forth an approach for … Continue Reading

FDA Issues Draft Guidance on IDE Decisions and New Pre-Decisional IDE Program

On June 14, 2013, FDA issued a draft guidance, “FDA Decisions for Investigational Device Exemption (IDE) Clinical Investigations,” to clarify the regulatory implications of FDA’s IDE decisions and to propose a new program to facilitate trial designs in support of marketing approval or clearance. FDA may take three actions with respect to IDE applications: approval, … Continue Reading

FDA Releases Final Guidance on Priority Review of Premarket Submissions for Devices

On May 17, 2013, FDA issued a guidance document regarding priority review of premarket submissions for devices.  This newly released guidance supersedes the document “Expedited Review of Premarket Submissions for Devices,” which the agency issued in 2008, and incorporates changes from the Medical Device User Fee Amendments of 2012 (MDUFA III).  As part of its … Continue Reading

FDA Finalizes CDRH Appeals Process Guidance, Issues Draft Guidance on Section 517A

On May 17, 2013, FDA took significant steps to update its appeals process for medical devices.  First, FDA finalized its guidance on CDRH Appeals Processes, which “describes the processes available to outside stakeholders to request additional review of decisions or actions by CDRH employees.”  Second, FDA issued a new draft guidance on Questions and Answers … Continue Reading

Use of New Administrative Order Authority to Up-Classify Devices: Proposed Order on “Sunlamp Products” Offers Glimpse Into FDA’s Approach

On May 6, 2013, FDA issued a proposed order to reclassify ultraviolet (UV) lamps intended for tanning from class I devices (general controls) exempt from premarket notification to class II devices (special controls) subject to premarket notification.  FDA also proposed to change the focus of the classification regulation from “ultraviolet lamps” to “sunlamp products,” including … Continue Reading

FDA Plans to Complete Classifications of Preamendment Devices by the End of 2014

Last month, FDA announced that it plans to complete classification actions for remaining preamendments devices by the end of 2014.  These actions could take the form of orders requiring the filing of premarket approval applications (PMAs) or notices of completion of a product development protocol (PDPs) for various devices (referred to as “calls for PMAs”) or reclassification orders.  With the … Continue Reading

Congress Shows Continued Interest In Mobile Medical Apps

Congress seems to agree that one of the most interesting issues in device law right now is FDA’s ongoing attempt to develop a regulatory framework for mobile apps that meet the statutory definition of a “device.”  On March 1, 2013, six Republican members of the House Committee on Energy and Commerce sent a letter to … Continue Reading

Regulatory Developments on the Horizon for Personalized Medicine

Alberto Gutierrez, director of the Office of In Vitro Diagnostics and Radiological Health at FDA, recently described the regulatory environment for personalized medicine as “chaotic,” noting the need for FDA to provide better clarity on many issues.  Indeed, a strategic priority for the Center for Devices and Radiological Health (“CDRH”) in 2013 is to further … Continue Reading

Metal-on-Metal Hip Implants: FDA Proposes to Require Premarket Approval

On January 18, 2013, FDA issued a proposed order that would require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for metal-on-metal hip joint implants. Metal-on-metal hip replacement implants were marketed prior to the Medical Device Amendments of 1976, which gave FDA authority over medical … Continue Reading

FDA Requests Comments Regarding Amended “Custom Devices” Exemption

On November 19, 2012, FDA issued a Federal Register notice seeking public comments on amendments to the custom device exemption that were enacted as part of the Food and Drug Administration Safety and Innovation Act (FDASIA).  FDA also announced it intends to issue a draft guidance relating to custom devices in 2013, as the Agency’s … Continue Reading

Unique Device Identifier Implementation Timeframe Amended

On November 19 FDA announced that it was amending its proposed rule to establish unique device identifier (UDI) requirements.  The amendments are necessary to comply with implementation deadlines of the Food and Drug Administration Safety and Innovation Act (FDASIA), which was enacted the day before FDA published the proposed rule in July 2012. FDA had … Continue Reading

Mobile Medical Apps: What Will Future FDA Regulation Look Like?

Over the next year, stakeholders may see several important developments related to FDA’s regulation of mobile health (also known as “mHealth”) devices, especially in the rapidly developing area of mobile medical apps. The universe of mobile medical applications (or “apps”) continues to grow rapidly. According to a recent Washington Post article, MobiHealthNews, an app-developer trade … Continue Reading