The US Food and Drug Administration (FDA) has announced that it will seek to regulate transvaginal mesh products more stringently, calling them high-risk devices that will be required to undergo FDA's thorough premarket approval (PMA) process. Background Transvaginal mesh has been used to treat female urological conditions, and in particular those caused by weakened pelvic muscles, which can lead to a pelvic organ prolapse (POP). In the EU, they have been used since the...

A new regulation proposed today by the US Food and Drug Administration (FDA) would change the procedures by which it classifies and reclassifies medical devices according to their perceived risk, making it much easier for FDA to make changes based on new or changing information. Background The proposed regulation was called for by a 2012 law known as the Food and Drug Administration Safety and Innovation Act (FDASIA) . Section 608 of the law called for FDA to be give...

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...

The US Food and Drug Administration (FDA) has moved to reclassify two medical device products under its class II special controls, just months after the FDA Safety and Innovation Act (FDASIA) made it easier for the agency to reclassify older, pre- Medical Device Amendments (MDA) devices. The two types of devices- external cardiac compressors , also known as chest compressors, and membrane lungs for long-term pulmonary support , also referred to as extracorporeal mem...

Following a review conducted by its experts, China's State Food and Drug Administration (SFDA) notified provincial and municipal agencies on 12 September 2012 of the classification of 73 medical devices. Nine devices were classified as Class III (implanted or life supporting devices); 41 as Class II (controls needed to ensure safe use); three as Class I (safety assured through routine administration); and 20 reclassified as non-devices.  Examples of new classif...

The US Food and Drug Administration (FDA) announced Friday, 6 July that it wants to require sponsors of shortwave diathermy (SWD) devices to file either a premarket approval application (PMA) or complete a product development protocol (PDP) for all but one of the device's indications. SWDs are used to generate deep heat in body tissues using electromagnetic energy. Though they are primarily used to raise the heat of the body tissue, some medical device manufacturers have...

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has opened a consultation on a new draft guideline clarifying how a company can initiate the regulatory review process for a major new reclassification of a drug product. All medicines marketed in the UK are classified according to one of three categories:  (1) Prescription Only Medicines (POM) - available only on a prescription;  (2) Pharmacy (P) - available under the supervision of a pharma...

After a series of problems in which permanent pacemaker electrodes have been associated with adverse events, the US Food and Drug Administration (FDA) said it will reclassify the electrodes as Class III medical devices. As a result of the reclassification, manufacturers of permanent pacemaker electrodes will now be required to submit either a premarket approval application (PMA) or complete a product development protocol (PDP) in order to legally market a permanent pacema...

The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) has released an updated schedule describing the classification timelines of 26 device classes. The 17 February release of the schedule is a part of CDRH's 515 Program Initiative, which is part of CDRH's overall Transparency Initiative . The 515 Program is named after Section 515 of the Federal Food, Drug and Cosmetic Act (FD&C Act) which covers the reclassification o...