Regulatory Challenges in Biomaterials: Focus on Medical Devices - Biomaterials Science: An Integrated Clinical and Engineering Approach - page 239

Examples of Class I and Class II devices exempted from 510k because the
material used for these kinds of devices existed before 1976 are neurologi-
cal devices such as two-point discriminators made of stainless steel, dental
materials such as carboxymethylcellulose sodium denture adhesive, and a
hydrogel wound dressing used in plastic surgery.
Exemptions to the regulations occur when the FDA decides to refocus the
resources used to assess 510k notifications onto public health issues of higher
priority.
A complete list of Class I and Class II devices exempted from 510k is avail-
able from the FDA site [30].
Even when a medical device is exempted from submitting a 510k, the fol-
lowing information should still be submitted:
• Registration and listing
• Labeling
• Good manufacturing practices (GMPs). (It is worth noting the rel-
evance of standards in that devices not subjected to premarket noti-
fication are still required to present evidence of compliance with
manufacturing standards.)
Premarket Approval (PMA) The premarket approval is the way in which the
FDA assesses Class III devices. The PMA is required when it is not possible to
prove substantial equivalence to an existing device, and therefore, in addition
to bench and pre-clinical data, additional clinical data must be provided to
demonstrate the effectiveness and safety of the investigational device. This is
clearly the hardest and more expensive way of bringing medical devices to the
market. High-risk, innovative devices are more likely to follow this pathway.
Two other important categories or pathways are the Investigational Device
Exemption (IDE) and the Humanitarian Device Exemption (HDE).
Investigational Device Exemption (IDE) If a device is intended to be used for
the first time in a clinical trial (see further), an IDE must be submitted to the
FDA by the manufacturer. An IDE could be required by the CDRH to support
a 510k or PMA application when clinical data are needed. If the device is Class
III, there is also a need for an Institutional Review Board (IRB) approval. As
previously described in this chapter, as a reaction to the atrocities committed
during World War II, a code of conduct in clinical research was created by
consensus and formally written in the form of declarations. An IRB ensures
that the principles behind these declarations will be followed. Therefore, the
aim of an IRB is to ensure that the rights of the subjects enrolled in a clini-
cal study will be protected [3, 6]. An IDE should also be submitted when the
sponsor wants to submit a new use for an existing device.
Humanitarian Device Exemption (HDE) Medical devices that will be used for
rare diseases affecting fewer than 4,000 patients a year in the United States