Medical device regulators

FDA s medical device regulations relating to adulteration and misbranding generally apply to devices intended for use on animals. These devices, however, are exempt from the 510(k) and PMA requirements. FDA has viewed animal grooming products as being outside of its purview. 

A. Small business assistance programs under Section 10 of the amendments (See PL 94-295). Both CDER and CDRH will identify any unique problems relating to medical device regulation for small business ... 

E. Medical Device Reporting. The manufacturers, distributors, importers, and users of all devices, including those regulated by CDER, shall report to CDRH under Section 519 of the Act as required. The Center for Devices and Radiological Health will provide monthly reports and special reports as needed to CDER for investigation and follow-up of those medical devices regulated by CDER. 

The Commonwealth Therapeutic Goods Amendment (Medical Devices) Act 2002 and the Therapeutic Goods (Medical Devices) Regulations 2002 came into effect from October 2002. Under the... 

Revision of medical device regulations has occurred in other countries, including Canada and the United States, because of the European experience. In 1998, Canada changed its device regulations to include a risk-based classification system and 11 principles of safety and effectiveness, which were patterned after the essential requirements of the European MDD (22). 

Trends Over Time The FDA Modernization Act, Team Biologies, New Medical Device Regulations, and Quality Systems Inspection (QSI)... 

The new medical device regulations were codified in 1996, significantly altering the way in which medical device manufacturers were inspected by the FDA. The quality systems inspection technique (QSIT) was launched as part of the new strategy for inspecting the device industry. This inspection technique allowed FDA to move closer to global harmonization guidelines... 

Heller, M. A., Guide to Medical Device Regulation, Thompson Publ. Group, Inc., 2003. 

Uuited Kingdom Medical Devices Regulations (1994), Regulation 2(1) SI 1994 No. 3017 (this U.K. regulation implements EU Directive 93/42/EEC). 

The six programmes that constitute the TTP are the Pharmaceutical Assessment responsible for premarket evaluation of drugs the Medical Devices Programme responsible for the administration and enforcement of the new medical devices regulations the Biologies and Radiopharmaceuticals Bureau Drug Surveillance Compliance and Enforcement and the Policy and Coordination Division. 

Medical devices Regulations and directives exist. Products belonging to this category require prior registration before they may be marketed (See page 245). 

A medical device is defined in The Medical Devices Regulations 1994 No 3017 cis ... 

UK Medical Devices Agency (MDA) Medical device regulations and guidance notes for industry on European Directives for medical devices Web site httpWwww. medical-devices.gov.uk/... 

There is variability between regnlators on the characteristics of software systems which constitute being a medical device and the Global Harmonization Task Force has gone some way to standardising definitions [64]. In practice HIT systems which fall into medical device regulation typically include ... 

Most medical device regulators require that manufacturers implement an appropriate quahty management system as part of their production process and in practice the requirements tend to be closely related to ISO 9001. The standard has been adapted to meet the requirements of several quality-critical industries including a version for the manufacture of medical devices. This adaptation is known as ISO 13485 2003 [10] and applies to the production of both software and physical devices. The standard is supported by technical guidance document ISO/TR 14969 2004 [17]. 

Many industries including nuclear engineering, aviation and the military have come to realise that human-system interaction can have a major impact on safety. In these domains regulatory processes have been put in place to mandate usability evaluation. Both the US FDA rules and Europe s Medical Device Directive require manufacturers to undertake usability studies (see Sect. 4.2.7). Even for products outside of medical device regulation, the contribution of usability issues to patient... 

Currently there are no specific standards which prescribe HIT software testing methodologies outside of formal medical device regulation. There are however a number of standards such as ISO/IEC 25010 2011 [3] which set out general requirements of software testing and quality management. 

I wrote this book to fill a gap. There is much in the literature about patient safety, medical informatics and the engineering of safety critical systems, but outside of medical device regulation little is said about how we manufacture and implement Health IT safely. In this book I have attempted to consolidate what the industry has learnt over a 10-15-year period. As technologies and techniques evolve it is clear that this is just the start of an exciting journey, the birth of an academic discipline which brings together learnings from many disparate sources. 

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