The FDA, or the Food and Drug Administration is a US federal government agency which has as its primary aim to protect and promote the health of consumers. Manufacturers and importers who distribute certain products to the US market must make FDA compliance their priority. If a product is not deemed compliant, it may be held in customs custody.

The types of products that the FDA governs approval of are food products, drugs for animal and human use and medical devices, amongst certain other items. Hence the importance of FDA compliance for the pharmaceutical and medical device industries. A product with FDA compliance has been the subject of very specific tests and examinations relating to its safety and efficacy. This means that the FDA has approved the product for distribution and sale.

There are many requirements which must be met before FDA compliance can be granted in the pharmaceutical and medical device sectors. For example, it is a requirement that manufacturers and distributors of medical devices register every year with the FDA.

To achieve FDA compliance in the medical device industry, good manufacturing practices must be met.  The FDA uses the check for good manufacturing practices to ensure that medical devices are consistently at the required standard. The organisation measures FDA compliance against various criteria relating to manufacture, design, packaging, storage, labelling and installation.

The FDA’s powers of regulation stretch across manufacture, testing and even labelling in the medical device industry. This means that even labelling and product literature must be sure to achieve FDA compliance.

The organisation continues to monitor devices after FDA compliance has been established. This allows any potential problems to be dealt with safely and quickly.

 Mail this post

StumbleUpon It!