The Medical Device Amendments of 1976 to the Food Drug and Cosmetic Act led to the classification of approximately 1,700 different generic types of devices with 19 medical specialties and three regulatory classes of devices based on risk. What complicates matters even more with regards to the medical device industry is the fact that devices can range from toothbrushes to eye glass lenses, to lasers to prosthetics.
Whether you product is a class I, II or III device, EAS Consulting Group, LLC. has the expertise to provide wide-reaching guidance as well as act as a conduit between manufacturers and marketers of devices and FDA.
Class I – General Controls
Class II – General Controls & Special Controls
(Special controls are Special controls are usually device-specific and include performance standards, postmarket surveillance, Patient registries, special labeling requirements, premarket data requirements)
Class III – General Controls and the requirement of Premarket Approval for all Class III devices
- Class III devices receive the greatest regulatory oversight and are those which support or sustain human life or is of substantial importance in preventing impairment of human health or presents a potential, unreasonable risk of illness or injury
No matter the type of device, whether your company is in need of a 510(k), a Premarket Approval, IDE, QSR audit, US Agent or registration assistance or the filing of petitions, exemptions and responding to warning letters and 483s, EAS can help.