Tag Archives: Clinical Trials

CFDA and CMDE Issue Draft Guidance on Medical Devices for Rare Diseases

On February 6, 2018, the China Food and Drug Administration (CFDA) and its Center for Medical Device Evaluation (CMDE) issued a draft guidance entitled “Guidance on the Review of Medical Devices for Preventing and Treating Rare Diseases.” The draft guidance is based on the reform measures recently outlined in the government’s broad blueprint for drug … Continue Reading

FDA Publishes Draft Guidance on Investigational IVDs Used in Therapeutic Product Clinical Trials

On December 18, 2017, FDA announced the availability of a new draft guidance, titled “Investigational IVDs Used in Clinical Investigations of Therapeutic Products.”  The draft guidance is intended to inform both product sponsors and IRBs regarding the application of the Investigational Device Exemption (IDE) regulation to investigational in vitro diagnostic devices (IVDs) used in therapeutic … 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FDA Releases Draft Guidance on the Use of EHRs in Clinical Investigations

On May 17, 2016, FDA issued draft guidance encouraging clinical investigators to make their electronic data capture (“EDC”) systems interoperable with health care organizations’ electronic health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

CFDA Releases New Device Clinical Trial Exemption Catalogues for Comment

On May 20, 2016, the China Food and Drug Administration (“CFDA”) published drafts of two medical device clinical trial exemption catalogues on Class II and Class III devices for public comment (“CFDA Draft Catalogues”).  Comments are due on June 20, 2016.  This is the second round of clinical trial exemption catalogues since the revisions to … Continue Reading

China’s New Medical Device Good Clinical Practices to Go Into Effect June 1, 2016

The China Food and Drug Administration (“CFDA”) and National Health and Family Planning Commission of China (“NHFPC”) have jointly released a revised and substantially expanded set of Good Clinical Practices for Medical Device Clinical Trials (“New Device GCP”), which will go into effect on June 1, 2016.  The New Device GCP are an important piece … 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 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

FDA Issues Draft Guidance Concerning the Use of Electronic Informed Consent in Clinical Investigations

On March 9, FDA announced the availability of a draft guidance document focusing on the use of electronic informed consent (eIC) in clinical investigations. The document provides recommendations for investigators, sponsors, and institutional review boards (IRBs) concerning eIC, which refers to “using electronic systems and processes that may employ multiple electronic media (e.g., text, graphics, … Continue Reading

CFDA Proposes New Regulations on the Accreditation of Medical Device Trial Sites

On December 15, 2014, the China Food and Drug Administration released proposed Measures for the Accreditation of Medical Device Clinical Trial Institutions (Measures) for public comment. The comments are due on February 28, 2015. The Measures articulate the process by which medical institutions in China can apply to the government to become accredited to conduct … 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 Guidance on Design Considerations for Pivotal Clinical Investigations for Medical Devices

On November 7, 2013, FDA published its final guidance document on Design Considerations for Pivotal Clinical Investigations for Medical Devices.  The 57-page guidance finalizes a draft guidance issued by the agency on August 15, 2011.  The guidance “is intended to provide guidance to those involved in designing clinical studies intended to support premarket submissions for … Continue Reading

FDA Proposes New Pre-Decisional IDE Program

Yesterday, we discussed a new draft guidance issued by FDA concerning IDE decisions.  While that post focused on FDA’s IDE decision-making process and the regulatory implications of those decisions, this post addresses a new program within CDRH—the Pre-Decisional IDE program—that FDA proposed in the draft guidance. To further help applicants reach their goal of device … 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

Federal Circuit Declines to Hold On Summary Judgment That Third-Party Clinical Trial Was Invalidating Public Use

In Dey, L.P. v. Sunovion Pharms., Inc., the Federal Circuit provided guidance for determining whether the use of a formulation during a clinical trial constitutes a “public use” sufficient to invalidate a patent claiming the formulation. Appeal No. 2012-1428 (Fed. Cir. May 20, 2013). The parties, Dey and Sunovion, are competitors that both own patents … Continue Reading

FDA Finalizes Guidance on Financial Disclosures by Clinical Investigators

FDA issued a final guidance on disclosure of financial interests of clinical investigators.  FDA intends for the guidance to assist clinical investigators, clinical trial sponsors, and applicants in complying with 21 C.F.R. Part 54.  The guidance finalized and revised a draft guidance issued May 2011 and replaces a prior guidance issued in 2001. Under the … Continue Reading

Proposed FDA Rule Requires “Good Clinical Practice” in Foreign Device Studies and Extends GCP Requirements to All Studies Supporting Device Submissions

On February 25, 2013, FDA issued a proposed rule incorporating the principles of “Good Clinical Practice” (“GCP”) into the requirements for FDA acceptance of data from clinical studies conducted outside the United States, and extending such requirements to studies supporting all types of device submissions, for both U.S. and foreign studies.  Under the proposed rule, … Continue Reading

Medical Device M&A: Best Practices for Due Diligence

Merger and acquisition (M&A) activity in the medical device space has slowed in recent years, but is poised to take off in 2013.  The medical device industry faces a complex and ever-changing regulatory environment, and it is critical to understand and assess these regulatory risks when evaluating potential medical device deals.  An acquirer can identify … Continue Reading
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