FDA Reclassifies Ophthalmic Device, Issues Special Controls
The US Food and Drug Administration (FDA) has announced that it will reclassify stainless steel scleral plugs as class II medical devices, thereby allowing the devices to be approved under the premarketing notification process [510(k)] instead of the premarket approval process.
Background
Scleral plugs are used to temporarily close scleral-the sclera is the white of the eye-incisions made during eye surgery. For example, during a trabeculectomy, a small circular hole is cut in the sclera to relieve intraocular pressure caused by the buildup of fluids. A scleral plug is then inserted after to temporarily close the hole before it is eventually sutured.
Under FDA's regulatory paradigm for devices, products fall into one of three categories:
- Class I (low risk) devices - general controls
- Class II (moderate risk) devices - special and general controls
- Class III (high risk) devices - premarket approval
For class I or II devices, if manufacturers can show that they meet the control measures-which is to say, standards-issued by FDA, the agency will allow it to be marketed without having to go through a more rigorous regulatory review.
By classifying scleral plugs as Class II devices, FDA is now permitting manufacturers to bring them to market using a 510(k) application instead of a much costlier premarket application (PMA). Further, if the devices are made from surgical grade stainless steel, FDA said a manufacturer will be exempted from the premarket notification process as well, similar to a Class I device.
Special Controls
The special controls the device will need to meet are as follows:
(1) The device is exempt from the premarket notification procedures […] if the material is a surgical grade stainless steel with or without a gold, silver, or titanium coating. The special controls for the surgical grade stainless steel scleral plug (with or without a gold, silver, or titanium coating) are:
(i) The device must be demonstrated to be sterile during the labeled shelf life;
(ii) The device must be demonstrated to be biocompatible; and
(iii) Labeling must include all information required for the safe and effective use of the device, including specific instructions regarding the proper sizing, placement, and removal of the device.
(2) The device is not exempt from premarket notification procedures if it is composed of a material other than surgical grade stainless steel (with or without a gold, silver, or titanium coating). The special controls for scleral plugs made of other materials are:
(i) The device must be demonstrated to be sterile during the labeled shelf life;
(ii) The device must be demonstrated to be biocompatible;
(iii) Characterization of the device materials must be performed;
(iv) Performance data must demonstrate acceptable mechanical properties under simulated clinical use conditions including insertion and removal of the device;
(v) Performance data must demonstrate adequately low levels of the extractables or residues from manufacturing (or processing) of the device; and
(vi) Labeling must include all information required for the safe and effective use of the device, including specific instructions regarding the proper sizing, placement, and removal of the device.
The change goes into effect on 16 December 2013.