Device Related Guidelines - Worldwide Overview

Recently updated and newly issued documents.

Title	Country Status
Labelling
Draft Guidance for Industry and FDA Staff: Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use Federal Register, 28 October 2003, 68(208), 61449-61451 This guidance addresses the use of selected symbols in place of text to convey some of the information required for in vitro diagnostic devices (IVDs) intended for professional use (see RAJ Devices, 2003, 11(6), 369 and 375). The document includes a number of suggested symbols with an accompanying glossary in order to help IVD manufacturers create uniform labels and labelling for the US and the EU, as it is encouraged in the EU IVD Directive which came into full effect in EU member states on 8 December 2003.	USA Draft Comment period closed. Submit general comments at any time
Draft Guidance for Industry and FDA Staff: Premarket Submission and Labeling Recommendations for Drugs of Abuse Screening Tests Federal Register, 2 December 2003, 68(231), 67460-67461 This guidance assists manufacturers in preparing pre-market submissions for in vitro diagnostic devices (IVDs) that screen for drugs of abuse (e.g. amphetamines, cocaine, methamphetamine, opiates, cannabinoids and phencyclidine) and provides recommendations on the labelling of these tests. The devices covered by this document are assays intended for the qualitative and semi-qualitative measurement of drugs of abuse in single-use (i.e. home testing), traditional laboratory use and multiple-use settings (i.e. workplace or similar settings). The tests may be designed to detect drugs of abuse in urine, hair, saliva or other matrices; they may be read by automated analysers or by visual interpretation. In the document, the FDA clarifies that pre-market notification submissions for drugs of abuse screening tests used in workplace and other repetitive testing sites may not require the same types of data as submissions for screening tests that are intended for sale directly to untrained users who perform these tests on an occasional basis (e.g. home tests). It also recommends cautionary labelling and other controls to address concerns over possible inaccurate preliminary results. This document replaces two draft guidance documents issued in 2000 (Over the Counter (OTC) Screening Tests for Drugs of Abuse: Guidance for Premarket Notifications and Guidance for Prescription Use Drugs of Abuse Assays Premarket Notifications).	USA Draft Submit comments by 1 Mar 2004
Procedural	Ireland Final Effective 4 Dec 2003
Guidance Note 11: Introduction to the In-Vitro Diagnostic Medical Devices (IVD) Legislation Irish Medicines Board, 4 December 2003 This is the first in a series of guidance notes regarding the regulatory control of IVDs on the Irish market. It provides an overview of the European legislation currently in force, which has been transposed into law by way of S.I. No 304 of 2001, European Communities (In-vitro Diagnostic Medical Devices) Regulations, 2001. In addition, it discusses the following points: · products excluded from the legislation; · role of the competent authority (i.e. the Irish Medicines Board); · manufacturer and own brand labelling - a manufacturer is defined as the ‘person who is responsible for the design, manufacture, packaging and labelling of a device before it is placed on the market under his own name, regardless of whether these operations are carried out by that person himself or on his behalf by a third party’. The definition of manufacturer also applies to ‘own brand’ labelling of medical devices. An ‘own brand labeller’ is the person who places the product on the market under his/her own name or trademark and is therefore the manufacturer (as defined) for the purposes of the legislation. The ‘own brand labeller’ may not be the person who actually designed, manufactured, packaged or labelled the product; nevertheless the regulatory responsibility rests with him/her alone if he/she is responsible for placing the product on the market.); · classification of IVDs; · Irish notified body (there is currently just one notified body - the National Standards Authority of Ireland - for the purposes of IVD legislation in Ireland); · conformity assessment, after which the device may be CE-marked; · use of the common technical specification and standards; · competent authority contact with the manufacturer or authorised representative; · performance evaluation to ensure that products achieve their intended performance; · research-use only products, which are specifically excluded from the legislation; · labelling and leaflets (labelling and instructions for use must be available with every device); and · who to contact at the Irish Medicines Board.
Draft Guidance for Industry: Providing Regulatory Submissions in Electronic Format - General Considerations Federal Register, 22 October 2003, 68(204), 60395 In this document, the FDA discusses general issues common to all types of electronic regulatory submissions. It is a revision to guidance of the same name that was issued in 1999 and is updated to include information for the Center for Devices and Radiological Health (CDRH), the Center for Food Safety and Applied Nutrition (CFSAN) and the Center for Veterinary Medicine (CVM). It reflects advances in technology as well as lessons learned from experience with electronic submissions over the past several years. There is a new section describing the relationship of electronic submissions to 21 CFR Part 11 on electronic records and electronic signatures. In addition, there are updates on the recommendations for creating portable document format documents including specific guidance for the use of fonts and new file formats for data. The electronic transmission of files is also addressed.	USA Draft Revision 1 Comment period closed. Submit general comments at any time
Research-Based Web Design & Usability Guidelines HHS, 27 October 2003 This document has been issued by the US Department of Health and Human Services (HHS) in collaboration with the National Cancer Institute (NCI) to provide guidance on the design of websites for government, commercial, academic and other entities. The guidelines were originally developed by the NCI to help web managers and designers present cancer information on the web in a more usable fashion, but the scope has expanded to ensure the high-quality dissemination of web information on the issues that fall within the remit of the HHS.	USA Final Effective 27 Oct 2003
Guidance for Industry: Product Recalls, Including Removals and Corrections Federal Register, 31 October 2003, 68(211), 62090-62091 This guidance is intended to provide information to FDA-regulated industry about all aspects of voluntary and mandatory product recalls, including removing the product from the market and correcting the problem. It covers all FDA-regulated products (i.e. medical and radiological devices, drugs, including animal drugs, human biological products, including blood, human tissue and food, including animal feed) and outlines the information that manufacturers and distributors should provide to the FDA District Recall Co-ordinator as soon as possible after the decision to recall has been made and the co-ordinator notified. Such information includes product details (e.g. 510(k)/IDE/PMA number), codes (production identification numbers), information about the recalling firm, manufacturer information, identification of the firm responsible for the violation/problem, reason for the recall, health hazard assessment, volume of recalled product, distribution pattern and recall strategy. In addition, guidance is provided on public notification via press release or written recall notification letters. Recommendations are also given for evaluation of the recall with respect to its effectiveness, recall status reports, root cause of the problem that resulted in the recall, corrective actions to prevent future occurrences of the problem and termination of the recall.	USA Final Effective 3 Nov 2003 Submit comments at any time
Guidance for Industry and FDA Staff: Premarket Approval Application Modular Review Federal Register, 3 November 2003, 68(212), 62298-62299 In this document, the FDA is seeking to clarify which pre-market approval applications (PMAs) are appropriate for modular review, simplify submission procedures and improve the efficiency of the agency's review. A modular PMA is one that allows the applicant to submit pre-clinical data and manufacturing information for review while still collecting, compiling and analysing the clinical data. This guidance has been issued to reflect the enactment of the Medical Device User Fee and Modernization Act of 2002 (MDUFMA), which codified the modular review approach. It updates and replaces 1998 guidances entitled A Modular Approach to PMA Review and Guidance for the Medical Device Industry on PMA Shell Development and Modular Review by making the following changes: · clarifying that modular review should be limited to original PMAs (i.e. modular review is not ordinarily appropriate for PMA supplements); · modifying the procedures for preparing and submitting a modular PMA; · explaining the significance of timing for submission of the modules; · revising the sample shell and specifying the expected content of the modules; and · suggesting limitations to the total number of modules that should be submitted. Additionally, guidance addressing user fee payment procedures has been added.	USA Final Effective 3 Nov 2003 Submit comments at any time
Guidance for Industry: IRB Review of Stand-Alone HIPAA Authorisations Under FDA Regulations Federal Register, 7 November 2003, 68(216), 63110-63111 This guidance clarifies that the FDA will not require institutional review boards (IRBs) to interrupt enrolment in clinical investigations in order to review and approve stand-alone authorisations under the Health Insurance Portability and Accountability Act of 1996 (HIPAA). A stand-alone HIPAA authorisation is a document used to obtain permission from an individual for a covered entity to use and/or disclose the individual's identifiable health information for a research study. It differs from a subject's informed consent in that it focuses on the uses and disclosures of information that may be made, whereas an informed consent indicates that subjects understand the risks and benefits of the study and are willing to participate in it. The FDA will not take enforcement actions against IRBs that decide not to review stand-alone HIPAA authorisations prior to enrolling subjects in clinical investigations, even though the regulations governing IRBs require them to do so. Although most IRBs are not directly subject to the requirements in the HIPAA Privacy Rule, IRBs are required to review all written materials provided to potential research subjects, including stand-alone HIPAA authorisations obtained from entities that are subject to the Privacy Rule (covered entities, e.g. healthcare providers and healthcare plans). This guidance was issued in response to requests by IRBs for clarification on how this issue would be handled once the Privacy Rule came into effect in April 2003 (see RAJ Devices, 2003, 11(3), 179), as they were concerned that clinical investigations might be impeded because IRBs would be backlogged with requests to review thousands of stand-alone HIPAA authorisations. The requests also stated that some IRBs would halt clinical investigation enrolment pending their review of these stand-alone HIPAA authorisations.	USA Final Effective 21 Oct 2003 Submit comments at any time
Guidance for Industry and FDA Staff: User Fees and Refunds for Premarket Approval Applications Federal Register, 24 November 2003, 68(226), 65940-65941 In accordance with the Medical Device User Fee and Modernization Act of 2002 (MDUFMA), the FDA has issued this guidance to outline the various types of pre-market approval applications (PMAs), discuss the fees associated with each type and identify industry or FDA actions on submissions that may result in refunds of fees that have been paid. Specifically, it covers: · types of PMAs and PMA supplements that are subject to user fees; · exceptions to fees for original PMAs or supplements; · types of PMA supplements or submissions not subject to user fees; · refund of user fees: - when the FDA determines a product is not a device; - when the FDA refuses to file an application; - when an applicant withdraws a PMA; - for modular PMAs; and - for licensing agreement PMAs; · how to request a refund; · deadlines for requesting refunds; and · court review of FDA decisions on refunds.	USAFinal Effective 24 Nov 2003 Submit comments at any time
Guidance for Industry and FDA Staff: Expedited Review of Premarket Submission for Devices Federal Register, 26 November 2003, 68(228), 66463-66464 This document outlines the procedures the FDA intends to use for granting expedited review of pre-market submissions for devices (i.e. 510(k)s, product development protocols (PDPs) and ‘de novo’ or ‘risk based’ classification actions). Because it reflects the enactment of the Medical Device User Fee and Modernization Act of 2002 (MDUFMA), the document also explains the procedures that the agency plans to use to review and track expedited pre-market approval applications (PMAs) against the MDUFMA performance goals when the PMA applicant meets criteria above and beyond the statutory criteria, such as: · the PMA has been the subject of a pre-filing meeting between the applicant and the FDA; · the PMA is substantively complete as defined in the pre-filing meeting; and · the PMA identifies manufacturing facilities that are prepared for a GMP inspection at the time of submission. This guidance supersedes a 1998 guidance entitled PMA/510(k) Expedited Review - Guidance for Industry and CDRH Staff.	USA Final Effective 26 Nov 2003 Submit comments at any time
Guidance for Industry and FDA Staff: Bundling Multiple Devices or Multiple Indications in a Single Submission Federal Register, 26 November 2003, 68(228), 66461-66463 In this document, the FDA explains how it will implement its policy on bundling multiple medical devices or indications into a single pre-market submission to the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER). The FDA's ‘bundling policy’ was originally set out in a letter from the Secretary of Health and Human Services to Congress that accompanies the Medical Device User Fee and Modernization Act of 2002 (MDUFMA). The guidance includes frequently asked questions and an overview on bundling, as well as covering the following: · bundling of: - multiple devices within a generic device type in a single 510(k) or pre-market approval application (PMA); - differing generic device types in a single 510(k) submission or a single PMA; - multiple indications for use for a device in a single 510(k) or a single PMA; - a 510(k) device with a PMA device in a single submission; - changes that affect multiple devices of the same or differing generic types; and - reprocessed single-use devices in a single submission; ·in vitro diagnostic devices (IVDs) - specific considerations with respect to multiple analytes, multiple reagents, multiple intended uses, sample matrix, replacement reagent, process for multiple markers that require a PMA and IVDs regulated by CBER; and · bundling procedures. This document supersedes Section V (‘Bundling Multiple Devices in a Single Application’) of a guidance entitled Assessing User Fees: PMA Supplement Definitions, Modular PMA Fees, BLA and Efficacy Supplement Definitions, Bundling Multiple Devices in a Single Application, and Fees for Combination Products - Guidance for Industry and FDA (see RAJ Devices, 2003, 11(3), 189).	USA Final Effective 26 Nov 2003 Submit comments at any time

Sources

Guidance documents are accessible at the following website:

Ireland www.medicaldevices.ie

USA www.fda.gov/cdrh