Archives: FDA Device Regulation

Subscribe to FDA Device Regulation RSS Feed

2016 Year in Review: MDR Reporting Enforcement

In 2016, the Office of Compliance at the U.S. Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health issued a total of 17 warning letters to medical device manufacturers citing violations of its regulations under 21 C.F.R. Part 803 for adverse event and malfunction reporting and recordkeeping.  The 2016 warning letters inform current … 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On November 18, 2016, the U.S. Food and Drug Administration (FDA or Agency) announced that it would not finalize the draft guidance entitled Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs) (Draft Guidance) prior to the end of the Obama administration. As we previously reported, FDA issued the Draft Guidance on October 3, 2014.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 and CMS Permanently Establish Parallel Review

On October 24, 2016, the U.S. Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS) published a notice in the Federal Register announcing the indefinite extension of the Parallel Review Program.  The agencies’ decision was based on “positive experience” from the Parallel Review Pilot Program, which has allowed manufacturers to … Continue Reading

Industry Guidance on Unapproved or Off-Label Information Provides Insight Into Issues Under FDA Review

As we recently reported, in the wake of court rulings and settlements addressing the First Amendment in the context of providing truthful, non-misleading speech, including about unapproved (or, “off-label”) use of approved or cleared medical products, on September 1, 2016, the FDA issued a notice that it will hold a public hearing on November 9 and … 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Last week, FDA held a two-day public hearing to obtain input on its four draft guidance documents concerning human cells, tissues, and cellular and tissue-based products (HCT/Ps).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 Finalizes General Wellness Guidance

Last week FDA finalized a guidance document entitled “General Wellness: Policy for Low Risk Devices” in which the agency sets forth an approach to not regulate “general wellness products.”  This guidance document is important to the rapidly growing market for wellness products, which includes such things as activity trackers, smart watches, mobile apps, and other … Continue Reading

FDA Publishes Draft Guidance on Codevelopment of Companion Diagnostics

FDA recently published a draft guidance document titled “Principles for Codevelopment of an In Vitro Companion Diagnostic Device with a Therapeutic Product.”  A companion diagnostic is an in vitro diagnostic device that provides “information that is essential for the safe and effective use of a corresponding therapeutic product.”  The new draft guidance is intended by … 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

Senate HELP Committee Moves Forward With Companion Legislation to 21st Century Cures

As previously covered on this blog and in our alert, the U.S. House of Representatives passed the 21st Century Cures Act (H.R. 6) in July 2015.  The U.S. Senate Committee on Health, Education, Labor, and Pensions (commonly referred to as the “HELP Committee”) has worked on companion legislation to the House bill and, since February … 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

LDT Update: FDA and CMS Testify Before the House Energy & Commerce Subcommittee Following Year of Debate on Oversight of LDTs

On November 17, 2015, the House Energy & Commerce Subcommittee on Health held a hearing examining the regulation of laboratory developed tests (LDTs).  CMS Deputy Administrator Patrick Conway and CDRH Director Jeffrey Shuren testified regarding the respective roles of CMS and FDA in the oversight of LDTs. The day before the hearing, FDA issued a … 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’s Office of Planning Issues Report on Review Process for Combination Products

The pace and process used by FDA for the review of combination products has been the subject of considerable concern by many device companies.  On October 14, 2015, FDA’s Office of Planning issued a report summarizing a study of the intercenter consultation process for the agency’s review of combination products.  The report identifies several challenges … Continue Reading

FDA CDRH Announces Regulatory Science Priorities for FY 2016

Yesterday we published a post on the Covington eHealth blog regarding the FDA Center for Devices and Radiological Health (CDRH) Regulatory Science Priorities for FY 2016.  The post describes CDRH’s top ten regulatory science priorities with a particular focus on those related to leveraging Big Data and health information technology to inform regulatory decision making.… Continue Reading

FDA Proposes Amending the Definition of “Intended Use”

On September 24, 2015, FDA published a proposed rule that, if finalized, would amend the agency’s regulations defining “intended use” for drugs and devices.  Given the central role that  “intended use” plays in FDA’s regulatory system, we regard this as an important development. Background The concept of “intended use” has long served as a fundamental … Continue Reading

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
LexBlog