Header graphic for print
Focus on Regulation

Tag Archives: Medical Devices

FDA Clarifies Expectations for Use of Electronic Health Records in Clinical Investigations

On May 17, 2016, FDA published a Draft Guidance for Industry regarding use of electronic health records (EHRs) in clinical trials, building on previously issued guidance on computerized systems and electronic source data used in clinical investigations. As summarized below, this Draft Guidance provides a number of important recommendations to study sponsors who rely on electronic data that are generated and maintained by healthcare facilities in the routine care of patients.

New EMC Guidance Released by FDA

On November 2, 2015, the Food and Drug Administration (FDA) released a draft guidance document, “Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices,” describing the types of EMC information that should be provided in a premarket submission for electrically-powered medical devices. Read More: New EMC Guidance Released by FDA

FDA Offers Clarity of UDI Application to Kits

On January 4, 2016, FDA officially released a draft guidance document Unique Device Identification: Convenience Kits, with further information regarding the Unique Device Identifier (UDI) requirements for labeling and data submission for kits. Read More: FDA Offers Clarity of UDI Application to Kits

When to Alert the Public? FDA Issues New Draft Guidance Document Regarding Public Notification of Potential “Emerging” Safety Issues with Medical Devices

This past year, FDA’s (Center for Devices and Radiological Health CDRH) has dealt with several widely-publicized public health issues related to medical devices. Read More:  When to Alert the Public? FDA Issues New Draft Guidance Document Regarding Public Notification of Potential “Emerging” Safety Issues with Medical Devices

KNOWLEDGE ALONE ≠ INTENT: FDA Proposes To Trim One Basis for Determining “Intended Use” of Drugs and Devices

Last week, the U.S. Food and Drug Administration (FDA) published a proposed rule, 80 Fed. Reg. 57756 (Sept. 25, 2015), that at first blush is devoted to clarifying when a tobacco product may be subject to FDA’s regulation as a drug, device, or combination product vs. a tobacco product.  Slipped within this proposed rule, however,

First Custom Device Annual Report Due March 31, 2015

On September 24, the Food and Drug Administration (FDA) released a final guidance document clarifying the revised custom device exemption implemented in Section 520(b) of the Food, Drug, and Cosmetic Act (FDCA) by the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012. [1]/ The final guidance provides helpful clarification of various elements of

FDA Issues Two Proposed Guidance Documents For Laboratory Developed Tests

On July 31, 2014, FDA provided Congress advance copies of two proposed guidance documents regarding Laboratory Developed Tests (LDTs), which the Agency had planned to issue 60 days later.  The first is titled FDA Notification and Medical Device Reporting for Laboratory Developed Tests; the second is Framework for Regulatory Oversight of Laboratory Developed Tests.  (A

FDA Health IT Initiatives: OpenFDA and FDASIA Health IT Public Workshop

In the last month, the Food and Drug Administration (FDA) undertook two new steps related to Health IT in the United States While the FDA’s involvement in this area of technology remains very controversial, both projects sought to enhance collaboration with the Health IT industry. FDASIA Workshop First, on May 13-15, 2014, the FDA, Federal Communications Commission (FCC),

FDA Releases Draft Guidance Documents on New Expedited Access Program for Premarket Approval of Medical Devices and Premarket and Postmarket Data Collection

On 23 April 2014, the Food and Drug Administration (FDA) released two related draft guidance documents related to premarket approval (PMA) applications for medical devices. The first outlines an expedited access PMA program, building off the pilot Innovation Pathway program. The second addresses the agency’s plans for balancing premarket and postmarket data collection efforts. Both

New Borderline Guide concerning medical devices issued by the MHRA

On 5 February 2014, the UK Medicines and Healthcare Products Regulatory Agency (MHRA) published a guidance document[1] intended to assist manufacturers in determining whether their product falls within the definition of a medical device laid down in the Council Directive 93/42/EEC concerning medical devices. In its guidance, the MHRA underlines that a product will be

European Parliament plenary vote on revised medical devices package

On 22 October 2013, the European Parliament voted, during a plenary session, on two draft Regulations intended to replace the current Medical Devices Directive[1], the Active Implantable Medical Devices Directive[2], and the In Vitro Diagnostic Medical Devices Directive[3]. The draft Regulations[4] will now be discussed by the Council of the European Union (“Council”) which is

The European Commission adopts stricter rules concerning notified bodies

On Tuesday 24 September 2013, the European Commission adopted a Regulation intended to strengthen the criteria for the designation and supervision of notified bodies under the Medical Devices Directives[1]. On the same day, the European Commission also adopted a Recommendation concerning the tasks to be fulfilled by notified bodies when conducting audits and conformity assessment

FDA finalizes Mobile Medical Apps guidance

On 23 September 2013 the FDA released the long-awaited Mobile Medical Applications final guidance.1 Coming more than two years after its initial draft, the final guidance provides further clarity and insight into the FDA’s current thinking on the regulation of applications meant to run on a mobile platform or on a browser tailored for use on a

EU Parliament committee approves draft Regulations overseeing the revision of EU medical devices legislation

On Wednesday 25 September 2013, the European Parliament Committee on the Environment, Public Health and Food Safety (ENVI) voted on two draft Regulations intended to replace the current Medical Devices Directive, the Active Implantable Medical Devices Directive, and the In Vitro Diagnostic Medical Devices Directive. Members of the European Parliament’s (MEP) ENVI committee voted in

FDA and Other Government Agencies Focus on Radio Frequency Wireless Technology in Medical Devices

On August 13, 2013, the Food and Drug Administration (“FDA”) issued final guidance on design principles for medical devices using radio frequency (“RF”) wireless technology that are implanted or worn on the body and that are intended for use in locations such as hospitals, homes, clinics, and clinical laboratories.  This guidance comes as the FCC

FDA Seeks Enhanced Cybersecurity Risk Management Efforts, Including Premarket Submission Requirements, for Medical Device Manufacturers and Hospitals

Drawing on the increasing use of wireless, Internet- and network-connected medical devices, the Food and Drug Administration (“FDA” or “the Agency”) issued a draft guidance document for comment on June 14, 2013, proposing that manufacturers of medical devices that contain software, firmware, or programmable logic, address cybersecurity risks in premarket submissions.  The draft guidance, entitled,

IRS Publishes Final Regulations re Medical Device Excise Tax

In the December 7, 2012 Federal Register, the IRS issued the final regulations under the medical device excise tax, accompanied by interim guidance that deals with a number of time-sensitive issues including the determination of the taxable sales price and relief from the penalties associated with deposit with the IRS of the correct tax amount. 

Publication of new Ordinances concerning the prior approval of the French authorities for the advertising of certain high risk medical devices in France

On 19 December 2011, the Act on the reinforcement of the safety of medicinal and healthcare products was adopted in France[1]. This Act imposes new obligations on manufacturers concerning the advertising of medical devices. As a result of this Act and the related implementing Decrees No 2012-743 and No 2012-744 of 9 May 2012, the advertising

European Commission Proposes Overhaul of European Medical Devices Regulation

On 26 September, the European Commission published two draft Regulations (here and here) intended to replace the current Medical Devices Directive, the Active Implantable Medical Devices Directive, as well as the In Vitro Diagnostic Medical Devices Directive. The draft Regulations will now be discussed in the European Parliament and in the Council. The European Commission expects the proposals