Tag Archives: guidance document

CFDA and CMDE Issue Draft Guidance on Medical Devices for Rare Diseases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6, 2018, the China Food and Drug Administration (CFDA) and its Center for Medical Device Evaluation (CMDE) issued a draft guidance entitled “Guidance on the Review of Medical Devices for Preventing and Treating Rare Diseases.” The draft guidance is based on the reform measures recently outlined in the government’s broad blueprint for drug … Continue Reading

FDA Releases Draft Guidance on Dissemination of Patient-Specific Information by Device Manufacturers

Last month, the FDA released a draft guidance document on the sharing of patient-specific data associated with medical devices, including information recorded, stored, processed, retrieved, and/or derived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FDA Releases Draft Guidance on the Use of EHRs in Clinical Investigations

On May 17, 2016, FDA issued draft guidance encouraging clinical investigators to make their electronic data capture (“EDC”) systems interoperable with health care organizations’ electronic health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

Obama Administration Releases Final Data Security Policy Principles and Framework for Its Precision Medicine Initiative

As the White House continues to build out the details for the Precision Medicine Initiative (“PMI”), on May 25, 2016 it released a final set of principles on data security.  In a document that “provides a broad framework for protecting participants’ data and resources in an appropriate and ethical manner,” eight overarching data security policy … 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

FDA Issues Draft Guidance Concerning the Use of Electronic Informed Consent in Clinical Investigations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

FDA Finalizes Guidance Limiting Oversight of Certain Software Devices

On February 9, 2015, FDA issued a final guidance document “Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices,” in which the agency finalized a deregulatory policy for certain software devices.  FDA’s new guidance document largely confirms the enforcement policies set forth in the draft guidance document FDA issued in July … 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

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 the Evaluation of 510(k) Substantial Equivalence

On July 28, 2014, FDA issued an important final guidance relating to the Agency’s substantive review of 510(k) notifications, entitled “The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)].”  This guidance applies to the 510(k) review process for both diagnostic and therapeutic devices and is applicable to 510(k) reviews undertaken by the Center for … Continue Reading

FDA Relaxes Regulation of Certain Software Devices

On June 20, 2014, FDA issued a draft guidance entitled “Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices,” informing manufacturers and others “that the Agency does not intend to enforce compliance with the regulatory controls” that apply to these three types of devices. Medical device data systems (MDDS), medical image … Continue Reading

New UK Guidance on Software as a Medical Device

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has published guidance on software as a medical device, including apps.  The guidance aims to assist those working in healthcare, and software developers, to determine whether a specific piece of stand-alone software or an app constitutes a medical device.  The MHRA provides illustrative examples of software, … Continue Reading

New MHRA Guidance on Borderline Medical Devices

In February 2014, the MHRA published new guidance on borderline medical devices.  The guidance considers only medical devices within the terms of the Medical Device Directive and not the Active Implantable Medical Devices Directive or In Vitro Medical Devices Directive. Purpose and mode of action The MHRA makes clear that borderline determinations “will be based … Continue Reading

CFDA Issues Guide for Routine Inspections of Medical Device Manufacturers

On January 13, 2014, the China Food and Drug Administration (CFDA) issued a Guide for Regular Site Inspections of Medical Device Manufacturers.  The Guide is to be used by local authorities and inspectors during a site inspection of device manufacturing facilities.  It includes detailed guidelines as to all facets of the inspection, including the credentials … 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

UK NICE Considers Restrictions on Hip Replacement Implants

The UK National Institute for Health and Care Excellence (NICE) has issued draft guidance recommending tightening standards for hip replacement devices.  If adopted, the tougher standards could force the National Health Service (NHS) to stop using a significant number of existing devices, with obvious impacts on manufacturers of these products.… 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
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