Updated regulatory information
New Borderline & Classification Medical Device document
April 2012
Borderline cases are considered to be those cases where it is not clear from the outset whether a given product
is a medical device, an in vitro diagnostic medical device, an active implantable medical device or not. Or alternatively,
borderline cases are those cases where the product falls within the definition of a medical device but is excluded
from the Directives by their scope. Where a given product does not fall within the definition of medical device or is excluded
by the scope of the Directives, other Community and/or national legislation may be applicable.
Read document
Australian regulatory guidelines for medical devices
(ARGMD) Version 1.1, May 2011Read document
Directive on electronic instructions for use of medical devices March 2012The directive on electronic instructions for use of medical devices, 207/2012, was released 10MAR2012. A copy, is attached.
Read document
Report to congress on the FDA foreign officesFeb 2012This report describes the progress of the U.S. Food and Drug Administration (FDA or the Agency) in establishing foreign posts and the progress of those foreign posts in working with foreign government counterpart regulatory authorities and others in the countries in which the Agency has established such posts to accomplish the mission for which they were established. The report focuses on the action of these posts in relation to the agency’s seven primary objectives including: relationship building; obtaining information on the regulation, production, manufacture, and transport of products; proving information on FDA policies, laws, and regulations; engaging in technical cooperation and capacity building; conducting inspections and investigations; environmental scanning; and cooperation with other US governmental agencies.
Read more
Post Market Clinical Follow-up Studies - A Guide for manufacturers and notified bodies
MEDDEV 2.12/2 rev2
January 2012
The European Commision has issued updated guidance for medical device manufacturers and notified bodies on how to conduct post-market clinical follow-up (PMCF) studies. Such studies are one of several options available to manufactureres to fulfil their post-market surveillance obligations.
Read document
Draft Guidance document - The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]
27th December 2011FDA developed this draft document to provide guidance to industry and FDA staff about current review practices for premarket notification (510(k)) submissions. The intent of this guidance is to identify, explain, and clarify each of the critical decision points in the decision-making process FDA uses to determine substantial equivalence. This draft guidance is not intended to implement significant policy changes to the current 510(k) review process. Rather, the intent of this guidance is to enhance the predictability, consistency, and transparency of the 510(k) program by describing in greater detail the regulatory framework, policies, and practices underlying FDA’s 510(k) review. This guidance also updates FDA’s policies with respect to the Special 510(k) program.
FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.
Read document...
Guidance document - Enforcement policy for Premarket Notification requirements for certain Invitro Diagnostics and Radiology Devices
20th December 2011This document is intended to describe FDA’s intent with regard to enforcement of premarket notification (510(k)) requirements for certain in vitro diagnostic and radiology devices under 21 CFR Part 807, Subpart E. FDA intends to propose the downclassification and exemption from 510(k) requirements of the class II devices that are the subject of this guidance document because it believes the safety and effectiveness of these devices is sufficiently well established and they have sufficiently controlled risks that general controls are sufficient and a 510(k) review is not necessary to assure the safety and effectiveness of such devices, subject to the limitations to the exemption criteria found in 21 CFR 862.9, 21 CFR 864.9, 21 CFR 866.9, and 21 CFR 892.9.
Read discussion document
Draft guidance document - FDA decisions for Investigational Device Exemption (IDE) clinical investigations10th November 2011FDA has also released a draft guidance document, entitled “FDA Decisions for Investigational Device Exemption (IDE) Clinical Investigations,” developed to promote the initiation of clinical investigations for medical devices under FDA’s IDE regulations. This draft guidance document focuses more generally on the IDE process, providing sponsors with information regarding FDA’s intention to allow more flexibility addressing outstanding issues with the IDE application in order to allow the clinical investigations to begin without unnecessary delays.
Read discussion document...
Draft guidance document - Investigational Device Exemptions (IDE) for early feasibility medical device clinical studies, including certain first in human (FIH) studies
10th November 2011FDA announced the availability of a draft guidance document, entitled “Investigational Device Exemptions (IDE) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies,” intended to provide information as to how FDA will facilitate early feasibility studies of medical devices using appropriate risk mitigation strategies, as well as to inform sponsors as to what data FDA expects to be provided in support of an early feasibility study IDE application. In tandem with the release of this draft guidance document, FDA has initiated a pilot program for nine (9) sponsors of innovative device technologies to initiate early feasibility studies under IDEs, including FIH studies, by applying the draft guidance recommendations
Read discussion document...
Searchable database of Premarket Approval (PMA) Summary Review Memos for 180 day design changes2nd November 2011FDA announced availability of a new online searchable database of Premarket Approval (PMA) Summary Review Memos for 180-Day Design Changes, requests to make a significant change in components, materials, design, specification, software, color additive, and labeling to an approved premarket application or report. Establishment of this database is a pilot program under the Center for Devices and Radiological Health (CDRH) Transparency Initiative.
Go to database...
CDRH Report: Understanding barriers to medical device quality
31st October 2011
This report is the result of an initiative launched by the United States Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH), as part of an effort to assess and understand gaps in medical device quality. The work focuses on marketed product quality assurance, rather than pre-market activities. Its purpose is to provide a perspective on the state of medical device quality, as well as the challenges and opportunities for improvement.
Read report...
CDRH Report: Medical Device Pre-Market Programs: An Overview of FDA Actions
19th October 2011
Nearly two years ago, the FDA’s Center for Devices and Radiological Health (CDRH) recognized that, given the growing complexities of medical product development, we needed to re-evaluate and modernize our regulatory review processes in order to assure that patients had timely access to safe and effective medical devices.
At that time, CDRH began to undertake a new systematic approach to device regulation – one that continued to focus on protecting public health by assuring that devices are safe and effective, but also focused on promoting public health by facilitating device innovation.
Innovation became one of our top four strategic priorities.
Read report...
Driving Biomedical Innovation: Initiatives to improve products for patients
Today, advances in science are leading toward a fundamental change in the way medical treatments will be developed and used. Groundbreaking discoveries in complex chemistry and biosynthesis have resulted in promising new approaches for the development of drug candidates, advances in cellular and molecular biologies are creating novel strategies for new biologic therapies such as stem cell-driven products, and cutting-edge electronics, nanotechnology, and advances in materials sciences have revolutionized medical devices.
As a result, incredible opportunities await both American companies and patients.
Read report...
Regulatory Science in FDA's Centre for Devices and Radiological Health
The body of the report is an overview briefly describing the role of regulatory science in device development, pre-market and post-market assessment, and manufacturing. We also explain the seven major priority areas that comprise the focus of regulatory science in CDRH, with examples of each.
Read report...
EC Guidance on serious event reporting for clinical trials
The European Commission has published guidelines on serious adverse events reporting during clinical trials of medical devices.
These guidelines have been published as so-called “meddevs”, guidance documents issued by the commission which are not legally binding, but which set the blueprint of expected conduct among interested parties, such as manufacturers, notified bodies and competent authorities.
Meddev 2.7/3 contains guidance with recommendations on how to report serious adverse events (SAE) that occur in clinical investigations and includes a reporting form. This document has been published alongside Meddev 2.7/4, which sets out guidelines for manufacturers and notified bodies on how to conduct clinical investigations under the medical device directives.
Meddev 2.7.3
Meddev 2.7.4
FDA Pilot on UDI - ReportFor the past 2 years, FDA has been proactively exploring requirements and needs for implementation of a Unique Device Identification (UDI) system. In 2010, FDA has
focused UDI pilot activity efforts to work through and gather information on the business processes for those stakeholders (labeling organizations, FDA internal users, and a variety of end users across the general public) that will be part of the UDI database business processes (submission, receipt, and analysis and use of data). This feedback and review has helped identify issues and, where possible, answered questions related to stakeholders’ populating and using the UDI database (UDID) to improve the identification of device information and ultimately to improve the safe and effective use of the identified medical devices.
FDA Report on UDI.pdf
Possible process for overlapping evaluations of premarket medical products
FDA and the Centers for Medicare and Medicaid Services (CMS) are considering establishing a process for overlapping evaluations of premarket medical products, to
reduce the time between FDA marketing approval or clearance decisions, and CMS national coverage determinations, with the pilot program set to begin after public
comments have been reviewed and the two Agencies release a draft guidance. FDA and CMS also will consider establishing a voluntary process that would allow companies
to meet with both Agencies and develop clinical trial protocols that would meet each Agency’s statutory standard.
Read more...
FDA Suggest Changes to 510(k)The FDA recently released two "preliminary" sets of recommendations that aim to "focus on innovation, regulatory predictability, and patient safety." The agency said the recommendations aim to "strengthen and clarify" the 510(k) review process, and "seek to strike the right balance between the ability" to deal with "new science ... and to provide predictable regulatory pathways." Here are links to the suggested 510(k) changes:
• CDRH Preliminary Internal Evaluations -
Vol I: 510(k) Working Group Preliminary Report and Recommendations • CDRH Preliminary Internal Evaluations --
Vol II: Task Force on the Utilization of Science in Regulatory Decision Making Preliminary Report and Recommendations
More FDA News
12 Aug 2010 FDA and the Centers for Medicare and Medicaid Services (CMS), announced a memorandum of understanding (MOU). The MOU seeks to promote collaboration and enhance efficiency by providing for the sharing of information and expertise between the Federal partners.
Read more... 09 Aug 2010 Comprehensive list of all guidance documents currently in use at the Agency, published in line with FDA’s Good Guidance Practices (GGPs). Information on guidance documents added or withdrawn in the last five years is also included.
Read more...
Notified Bodies Operations Group guidance on Design, Dossier examination and report contentThe objective of this document is to give guidance to:
• the Notified Bodies (NB) of the type of content expected of the Notified Body Design Dossier Reports of Medical Device manufacturers to ensure manufacturer’s conformance
to the relevant Directive
• the Assessors of the Designating Authorities (DAs) on the content expected in the Notified Body’s Design Dossier Report
Read more...
MEDDEV 2.7.1
Clinical Evaluation; A Guide for Manufacturers and Notified BodiesThese guidelines on Clinical Evaluation are part of a set of Medical Device Guidelines that promote a common approach by Manufacturers and Notified
Bodies involved in clinical evaluation procedures according to the relevant annexes of the Medical Devices Directives and by the National Competent Authorities
charged with safeguarding public health.
Read more...
MEDDEV 2.1/3 Rev3
Medical Devices Guidance Document; Borderline DevicesRead more...
MEDDEV 2.12-1 Rev6
Medical Devices Guidance Document; Vigilance SystemThese guidelines on the Medical Device Vigilance System are part of a set of Medical Device Guidelines that promote a common approach by manufacturers and
Notified Bodies involved in the conformity assessment procedures according to the relevant annexes of the directives, and by the National Competent Authorities charged with safeguarding public health.
Read more...
Medical Device Directive (93/42/EEC)Read more...
Medical Device Directive (2007/47/EC)
Read more...
Medical Device Directive (90/385/EEC)
Read more...