Tag Archives: FDA

Breakthrough Devices Program: Draft Guidance to Implement 21st Century Cures

On October 25, 2017, FDA published a draft guidance that describes FDA’s proposed approach to implement the Breakthrough Devices Program (“BDP” or the “Program”), a voluntary program to expedite access to medical devices intended for treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. The BDP implements section 515B of the Federal Food, … Continue Reading

Letter to File or New 510(k)?: CDRH Finalizes Two Key Guidances

On October 25, 2017, FDA’s Center for Devices and Radiological Health (CDRH) issued two final guidance documents that provide FDA’s current thinking regarding whether a modification to a 510(k)-cleared device will require the submission of a new 510(k), or may be documented in a “letter to file” as part of the manufacturer’s quality system.  Such … Continue Reading

Practical Considerations for Device Industry Policyholders Experiencing Puerto Rico Hurricane Losses

Last week, FDA released a statement about the challenges facing the medical device manufacturing industry in Puerto Rico in the wake of Hurricanes Irma and Maria. FDA is concerned that the damage to the island will lead to shortages of important medical products. The statement highlights that device manufacturers both inside and outside Puerto Rico … Continue Reading

FDA Finalizes Guidance on Medical Product Classification

On September 26, 2017, FDA announced in a Federal Register notice the availability of the final guidance document, Classification of Products as Drugs and Devices & Additional Product Classification Issues.  This guidance provides the Agency’s current thinking on approaches for classifying products as drugs and devices, and on certain additional product classification issues, such as … Continue Reading

President Issues New Executive Order, Requires Agencies to Establish Regulatory Reform Task Forces

On February 24, 2017, President Donald Trump signed an executive order entitled “Enforcing the Regulatory Reform Agenda” (the “Order”).  The Order is one of several actions the Trump Administration has taken concerning regulatory reform since the presidential inauguration, and directs federal agencies to identify personnel to oversee the implementation of the Administration’s regulatory reform initiatives.  Among … Continue Reading

FDA Releases Draft Guidance on Manufacturers’ Communications with Payors

In January, FDA released a Draft Guidance on Drug and Device Manufacturer Communications with Payors, Formulary Committees, and Similar Entities (“Draft Guidance,” available here), which provides the Agency’s thinking on communications with payors in two areas: (1) communication of health care economic information to payors regarding approved drugs; and (2) communications to payors about investigational … Continue Reading

2016 Year in Review: FDA Advertising & Promotion Enforcement Activity

Warning and untitled letters issued to manufacturers of medical products offer unique insight into FDA’s enforcement practices. To help identify themes and trends in the agency’s recent enforcement activity, Covington & Burling has reviewed all warning and untitled letters related to advertising and promotional materials issued in 2016 and tabulated the most frequently cited allegations. … Continue Reading

FDA Issues Discussion Paper on Possible Regulatory Approach for Laboratory Developed Tests

On January 13, 2017, the U.S. Food and Drug Administration (FDA or Agency) released a discussion paper synthesizing public feedback on FDA’s 2014 draft guidance documents and outlining a possible approach to regulation of laboratory developed tests (LDTs) (Discussion Paper). This approach is intended to “advance the public discussion by providing a possible approach to … Continue Reading

CDRH Releases Postmarket Cybersecurity Final Guidance

On December 28, 2016, CDRH announced the publication of the final guidance “Postmarket Management of Cybersecurity in Medical Devices.”  In a separate post, we reported on the January 22, 2016 draft version of this guidance document.  The final guidance provides FDA’s recommendations on a risk-based framework for medical device manufacturers to assess and remediate cybersecurity … Continue Reading

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 Holds Public Hearing and Seeks Comment on Draft Guidances Concerning Regulation of HCT/Ps

Last week, FDA held a two-day public hearing to obtain input on its four draft guidance documents concerning human cells, tissues, and cellular and tissue-based products (HCT/Ps). Our client alert, accessed here, summarizes each of the guidance documents, highlights significant areas of discussion during the public hearing, and provides insights on potential areas for further discussion … Continue Reading

FDA to hold Public Hearing on Communicating Information about Off-Label Conditions of Use

Yesterday, FDA issued a Notice announced that it will be holding a 2-day public hearing on November 9-10, 2016 on “Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products.” In the Notice, the agency explained that “FDA is engaged in a comprehensive review of its regulations and policies governing firms’ communications about unapproved … Continue Reading

FDA Publishes Two Draft Guidances on Next Generation Sequencing Technology

FDA recently published two draft guidance documents related to the development of devices that utilize next generation sequencing (NGS) technologies. These two draft guidances support the Administration’s Precision Medicine Initiative (PMI), which is intended to promote technologies that use genetic, environmental, and other data to tailor health care tools to unique needs of individual patients.  … Continue Reading

FDA Releases Draft Guidance on Dissemination of Patient-Specific Information by Device Manufacturers

Last month, the FDA released a draft guidance document on the sharing of patient-specific data associated with medical devices, including information recorded, stored, processed, retrieved, and/or derived from the device.  FDA noted that patients increasingly seek to play an active role in their own health care and that providing patients access to information regarding medical … Continue Reading

FDA Releases Draft Guidance on the Use of EHRs in Clinical Investigations

On May 17, 2016, FDA issued draft guidance encouraging clinical investigators to make their electronic data capture (“EDC”) systems interoperable with health care organizations’ electronic health records (“EHRs”).  Although EHRs are generally under the control of health care organizations and institutions (not FDA-regulated entities such as sponsors), when records are used in clinical investigations, FDA … Continue Reading

After Two-Day Workshop, CDRH Releases Postmarket Cybersecurity Draft Guidance

On January 22, 2016, CDRH announced in the Federal Register the publication of the draft guidance, “Postmarket Management of Cybersecurity in Medical Devices.”  The release of the draft guidance coincided with the conclusion of a two-day public workshop hosted by FDA entitled, “Moving Forward: Collaborative Approaches to Medical Device Cybersecurity.”  We previously discussed the Agency’s … Continue Reading

CDRH Schedules January 2016 Cybersecurity Workshop

CDRH has scheduled a cybersecurity workshop entitled, “Moving Forward: Collaborative Approaches to Medical Device Cybersecurity,” on January 20-21, 2016 (see here for the Federal Register announcement). Background and Workshop Context As we discussed in a previous blog post, cybersecurity vulnerability is an increasing concern as medical devices are becoming more connected to the Internet, hospital … Continue Reading

Recent Reports Claim Improvements in FDA’s Review of Medical Device Submissions

Two recent reports cite gains made by the Center for Devices and Radiological Health (CDRH) in strengthening the clinical trial enterprise and shortening the review times for marketing applications for medical devices.  The reports suggest that CDRH’s review processes are becoming more efficient, and that on average applicants can expect shorter review times for investigational … Continue Reading

FDA Proposal to Regulate LDTs Raises Legal Liability Questions for Labs

Back in August, we wrote about the FDA’s controversial plan to release draft guidance on a new regulatory framework for Laboratory Developed Tests (LDTs) —  diagnostic tests developed by and used within individual laboratories across the country.  As it stands now, LDTs are overseen by the Centers for Medicare and Medicaid Services under the Clinical … 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

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
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