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Guide to designing for regulatory approval

Posted: 18 Sep 2015 ?? ?Print Version ?Bookmark and Share

Keywords:engineers? risks? product launch? FCC? CE?

To get regulatory approval it helps to understand how regulators think and what's important to them. Here are some key points engineers need to consider at the earliest possible stage of the design process.

Regulators view products in terms of the potential and actual risks they pose to users, patients, other persons and the environment. In general, the higher the risks associated with the product, the more regulatory requirements need to be fulfilled, and the higher the burden of proof on the designer and manufacturer.

Any risks identified in the design phase should be documented and reduced as far as possible prior to product launch. Users (and patients if applicable) need to be informed of any residual product risks by product labels and/or accompanying documents. Any new risks identified after the product has been placed on the market need to be addressed and mitigated. Product safety must be paramount in the design thought process.

Regulators expect that products are designed and manufactured in a way that ensures that the product fulfils its intended purpose for the expected lifetime of the product. Products must be durable and achieve the performance claimed by the manufacturer. Verification and validation testing must be performed at the design stage in line with product-related standards. Test protocols and records need to be documented and available for authorities.

The intended user of the product and the environment in which it is used must be considered in the design. For example, if a product will be used by a member of the public in a home environment, the education and age group of the user as well as the storage and operating conditions of the product in the home must be taken in to account. Information supplied with the product must be written at a level and in language that can be easily understood by the intended audience. The design requirements for products intended to be used by professionals such as doctors in a hospital environment are often quite different to that of lay users.

How the product works should inform the testing that will be necessary to meet regulatory requirements. For example, if the product has electrical components it will need to be EMC tested. If it incorporates wireless technology, it will need to comply with FCC standards in the U.S. and the Radio and Telecommunications directive 1999/5/EC in Europe.

Products that fall under the definition of a medical device are regulated by the FDA in the U.S. and are subject to the regulatory controls outlined in 21 CFR Parts 1-58, 800-1299. In Europe, the requirements of the Medical Device Directive 93/42/EC must be met and the product must be CE marked.

Regulations vary from region to region and are constantly changing. It is imperative that the markets for which the product is intended are defined at an early stage so that any particular requirements are captured before embarking on a verification and validation program.

About the author
Paula McCarthy is Senior Regulatory Affairs Advisor at Acorn Regulatory.

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