FDA and CGMP regulations for medical devices

As required by the Medical Device Amendments (MDA), all medical devices are subject to basic regulatory requirements - general controls - intended to provide reasonable assurance of a device's safety and effectiveness. As the risk of the use of a device to a patient increases, corresponding regulatory requirements are put in place to assure the device is safe and effective.

Suman Kumar, head - injectables packaging development, Macleods Pharmaceuticals, said at a packaging conference, “India is in a phase of development and many Indian companies are going for generic devices being used as pen and auto injectors. These devices have a huge segment for diabetic and rheumatoid arthritis patients.”

There are several types of medical devices available for injectable drug delivery. Among them, auto injectors and pen devices are most commonly used however they differ from each other based on mechanism. The primer is equipped with prefilled syringes, automatically inserts the needle and performs the injection via spring-driven action. The latter is usually cartridge based syringes.

The Food and Drug Administration (FDA) has come up with a streamlined approach with two sets of standards. First is quality standards, American regulations, and second is Current Good Manufacturing Practice (CGMP) based manufacturing.

Device manufacturers must comply with CGMP to assure that their products are safe, effective, and otherwise in compliance with the FFDCA. The CGMP regulations ensure that any pharmaceutical company implements strong quality control management systems for testing of raw materials in order to ensure that quality is built into the design and manufacturing process at every step.

Pursuant to the Food and Drug Administration Act of 2009, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorisation is prohibited.