Tag Archives: FDA

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

CDRH Releases 2015 Guidance Document Agenda, Announces Retrospective Guidance Document Review

On January 9, FDA announced the availability of a website that includes two lists of guidance documents that the Center for Devices and Radiological Health (“CDRH” or the “Center”) plans to publish in Fiscal Year (“FY”) 2015.  The first is a list of draft and final guidance documents that the Agency “fully intends” to publish (the … 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  The final guidance contains several changes from the draft guidance (see our blog on … Continue Reading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 Finalizes Guidance for Management of Cybersecurity in Medical Devices

The U.S. Food and Drug Administration (“FDA”) has increasingly focused on promoting cybersecurity because compromised medical devices can pose a risk to patient health as well as the confidentiality of personal medical information.  On October 2, 2014, FDA issued final guidance on the content of premarket submissions for the management of cybersecurity in medical devices.  … 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 Denies Citizen Petition’s Request to Ban Marketing of Non-Absorbable Surgical Mesh Products for Transvaginal Repair of Pelvic Organ Prolapse

On July 14, 2014, FDA publicly posted its response denying Public Citizen’s August 2011 citizen petition concerning the marketing of non-absorbable surgical mesh products for transvaginal repair of pelvic organ prolapse (POP).  In its response, FDA took the position that a ban or recall of POP devices is not warranted at this time. As background, … Continue Reading

FDA Launches OpenFDA To Ease Access to FDA Datasets — Which Creates Opportunities for Developers of Mobile Medical Apps

Last week, FDA launched openFDA­—its new, open government initiative.  Created in response to an executive order on transparency, openFDA will provide access to many of the agency’s health data sets.  FDA is encouraging developers of websites and mobile medical apps to process FDA’s health data so it is more useful for the public, clinicians, and … Continue Reading

FDA Issues Draft Guidance on Voluntary Consensus Standards

On May 13, 2014, FDA announced the availability of a draft guidance entitled “Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices.”  When finalized, the guidance will supersede FDA’s September 2007 guidance on the use of consensus standards.  The draft guidance is intended to provide further clarity to industry and FDA staff … Continue Reading

Senate Republicans Press FDA on Draft Guidances

On May 6, 2014, four of the ten Republicans on the United States Senate’s Committee on Health, Education, Labor, and Pensions (HELP) sent a letter (recently posted by Hyman Phelps) to FDA Commissioner Margaret Hamburg expressing “significant concern” about FDA’s penchant for using draft guidances to make “substantive policy changes.”  In addition to the Committee’s Ranking Member … Continue Reading

Upcoming Webinar: “Advertising Drugs and Health Care Products via Social Media: FDA Regulation”

On Wednesday, May 7, Covington attorneys Stefanie Doebler and Saurabh Anand will be participating in a webinar that might be of interest to many of the readers of this blog.  The presentation, entitled “Advertising Drugs and Health Care Products via Social Media,” will provide attendees with an overview of a recent FDA draft guidance addressing … Continue Reading

FDA Issues Revised Draft Guidance on Distributing Reprints

On March 3, 2014, FDA announced the availability of a revised draft guidance document entitled “Distributing Scientific and Medical Publications on Unapproved New Uses—Recommended Practices.”  This draft guidance revises the final guidance, “Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and … Continue Reading

FDA Issues Untitled Letter Focused On Promotional Claims On Facebook

On March 12, FDA’s Office of Prescription Drug Promotion (OPDP) posted an untitled letter on its webpage alleging that Institut Biochimique SA’s (IBSA) Facebook page for the drug Tirosint® misbranded the drug.  Though the enforcement letter discusses a drug, the principles discussed in the letter are instructive for medical device promotion activities.  The untitled letter … Continue Reading

FDA Issues Draft Guidance on Postmarketing Requirements for Promotion on Social Media

On January 13, 2014, FDA issued a draft guidance document entitled “Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics.”  This draft guidance addresses the procedural topic of submitting Forms FDA 2253 and 2301 when firms use social media such as blogs, microblogs, social networking sites, … 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

FCC Holds mHealth Expo to Connect Innovators and Regulators

On December 6, 2013, the FCC held an mHealth Innovation Expo to showcase the innovative use of mobile communications devices to improve health care.  Innovators at the expo had the opportunity to showcase mobile health products and solutions and provide resources for mobile health pioneers and entrepreneurs.  The FCC and other federal agencies, including the … Continue Reading

FDA Issues Final Guidance Regarding Research Use Only and Investigational Use Only Products

On November 25, 2013, FDA issued a final guidance on research use only (RUO) and investigational use only (IUO) products.  FDA describes RUO products as devices in the laboratory phase of development and IUO products as devices in the product testing phase of development.  RUO products also may be offered and promoted for non-clinical purposes, … 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

OMB Responds to Lawmaker Questions on Sequestered FDA User Fees

We have previously discussed the effect of sequestration on FDA user fees.  Pharmaceutical and device manufacturers pay these user fees into a fund, which the FDA then draws upon to accelerate approval of new products and devices.  However, despite the fact that these funds are paid by private industry and are not derived from general … Continue Reading

FDA to Reorganize its Device Compliance Office with Increased Focus on Oversight of Advertising, Promotion, and Premarket Requirements

FDA recently announced that it is planning to reorganize the Office of Compliance within the Center for Devices and Radiological Health.  The changes will become effective in mid-November. The Office of Compliance plans to move “from a product-based structure  . . . to a function-based structure.”  At the moment, the Division of Enforcement A and Division … Continue Reading

FDA Releases Final Mobile Medical Apps Guidance

On Monday, FDA released a final version of its guidance document, Mobile Medical Applications: Guidance for Industry and Food and Drug Administration Staff.    The guidance describes FDA’s approach for regulating certain mobile applications (apps) as medical devices under the Federal Food, Drug, and Cosmetic Act (FDCA). Although the final guidance retains the basic framework of the … 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

CDRH Issues Draft SOP for Level I, Immediately in Effect Guidance on Premarket Data Issues

Last week, FDA announced the availability of a draft standard operating procedure (Draft SOP) on CDRH’s process to quickly notify stakeholders when new scientific information changes CDRH’s expectations for the data required for premarket submissions, such as Investigational Device Exemption (IDE), Premarket Notification (510(k)), Premarket Approval (PMA), or Humanitarian Device Exemption (HDE) submissions.  The Draft … Continue Reading

Regulation of Combination Products: A Hybrid Approach to CGMP and Postmarketing Safety Reporting Requirements

Starting July 22, 2013, as part of their compliance with current good manufacturing practices (“CGMP”), pharmaceutical companies that manufacture combination products containing a device component became subject to device Quality System Regulations (“QSRs”). As we previously discussed, on January 22, 2013, FDA issued a final rule on CGMP requirements for combination products. Under the rule, … Continue Reading
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