The European Medicines Agency (EMA) has released a concept paper on the development of personalised medicines and companion diagnostics. EMA proposes to develop a guideline that will provide guidance relating to the interface between personalised medicines and companion diagnostics. Companion diagnostics are defined by the In Vitro Diagnostic Regulation as a medical device which allows
On June 9, 2017, the U.S. Food and Drug Administration (“FDA”) published a Federal Register Notice announcing that new 510(k) notices for a number of reusable medical devices will now require the support of validated instructions for use and reprocessing instructions addressing cleaning, disinfection, and sterilization.
Subject to certain exceptions, medical devices have historically not been heavily regulated in South Africa. Prescriptive requirements for medical devices were not in force and advertisers and marketers of medical devices had few legislative and regulatory formalities to comply with.
On 22 February 2017, the Council of the European Union issued the final versions of the draft texts of the European Union (“EU”) Medical Device Regulations (“MDR”) and the In Vitro Diagnostics Regulation (“IVDR”). The finalised versions of the draft texts are available here and here. Final Adoption of the texts anticipated in March The
On 13 December 2016, the French Decree 2016-1716 implementing the French Law 2016-41 modernising the French healthcare system (“French Law 2016-41”) was adopted. This Decree provides important information concerning the obligation for manufacturers of implantable medical devices and manufacturers of Class III medical devices to submit a summary of product characteristics to the French Agency
Effective January 6, 2017, the U.S. Food and Drug Administration (FDA) reclassified surgical instrumentation for use with urogynecologic surgical mesh for transvaginal pelvic organ prolapse (POP) repair from class I (general controls) devices to class II (special controls) devices. Surgical mesh—and the instrumentation for its administration—have been used for the transvaginal repair of POP since the
In a Federal Register notice published September 1, 2016, the U.S. Food and Drug Administration (FDA) announced a public hearing for November 9-10, 2016 on issues related to industry communications about unapproved uses of approved drugs, biological products and approved, cleared and exempt medical devices. FDA seeks input from a broad array of stakeholders, including
As they grow in popularity and functionality, mobile devices increasingly connect people virtually with the places and institutions they would otherwise visit in person. These include malls, banks, and even their own workplace. More and more, mobile devices are also connecting people with one of the places they least want to go: doctor’s offices.
Late on 25 May 2016, the Council of the European Union issued a press release to announce that the European Commission, the European Parliament and the Council had reached a political agreement concerning the text of the proposed Regulation on medical devices and the proposed Regulation on in vitro diagnostic medical devices. While this step
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.
On January 26, 2016, the Food and Drug Administration (FDA or the Agency) released a draft guidance document, Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices (Draft Guidance). Read More: FDA Offers New Recommendations for Interoperability of Connected Devices
The tax and spending bill signed into law by President Obama last week included a two year suspension of the medical device excise tax. After years of effort by industry to abolish the tax, proponents of the suspension speculate that it may represent a window to full repeal. Read More: Congress Suspends Medical Device Tax for Two
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
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
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
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,
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. / The final guidance provides helpful clarification of various elements of
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
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),
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
On 5 February 2014, the UK Medicines and Healthcare Products Regulatory Agency (MHRA) published a guidance document 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
On 22 October 2013, the European Parliament voted, during a plenary session, 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. The draft Regulations will now be discussed by the Council of the European Union (“Council”) which is
The U.S. Food and Drug Administration (FDA or the agency) issued the final Unique Device Identifier (UDI) rule on Tuesday 24 September 2013, following up on the draft rule previously circulated by the agency on 3 July 2012. Overview of the UDI requirements With limited exceptions, the rule requires that medical devices are labeled with
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. 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