After years of dialogue between the U.S. FDA and industry, the agency’s long-awaited draft guidance for computer software assurance (CSA) for manufacturing facilities signaled a new, less cumbersome approach to validating these systems. However, drug and device manufacturers registered concerns about a lack of clarity in the draft, including 23andMe Holding Co., which said the draft’s references to methods that merely “help to fulfill” validation requirements leave too much gray area to be helpful.
Acotec Scientific Holdings Ltd. obtained marketing approval from the U.S. FDA for its peripheral support catheter Vericor, designed to enhance access to peripheral vessels.
Patients with ophthalmic disease use eyedrop containers and eyecups millions of times a year, but these two devices have been treated as one device type and informally regulated as class II devices up to now. A U.S. FDA advisory committee recommended a class I designation for these products, which will relieve some of the burden on manufacturers, but the panel also endorsed that these two types of products be split into two separate product codes, which would greatly facilitate adverse event reporting.
The U.S. FDA has wrapped up its guidance effort to deal with counterfeit devices, an effort that consumed roughly 11 months. That span of time had little discernible effect on the draft, however, as the final guidance seems to leave the draft’s explanation that future FDA guidances may refer to more than one section of the statute in references to the definition of a device.
The U.S. FDA recently convened an advisory committee to address accuracy issues with pulse oximetry devices, with a significant focus on skin pigmentation as a source of noise in the results generated by these class II devices. However, a number of other factors, including obesity and finger size/diameter, also cloud the values generated by pulse oximeters, all of which combine into a large set of variables that premarket studies may have to address before the FDA will issue new marketing authorizations.
Avita Medical Ltd.’s Recell system won FDA breakthrough device designations in soft tissue repair and vitiligo. Melbourne-headquartered Avita, a regenerative medicine company developed the Recell system, a technology platform that enables point-of-care autologous skin restoration.
Teleflex Inc. issued a recall of its Iso-Gard S filters for respiratory equipment due to reports of separation, a problem that could impede the delivery of oxygen to patients. The class I recall was driven by 36 complaints and four injuries reported to the U.S. FDA, and affects more than 60,000 units shipped between Sept. 1, 2020, and July 5, 2022.
The U.S. FDA held a two-day advisory hearing in the last week of October 2022 to address some lingering regulatory questions, including the question of whether therapeutic nail prostheses should be a class I device. The potentially more dramatic shift, however, would be the application of a class III risk designation to tissue expanders used in breast surgery.
Just as the U.S. FDA gathered industry leaders to address the issues posed by pulse oximeters that provide inaccurate measurements for individuals with darker skin, Biointellisense Inc. released its own FDA-cleared technology that provides accurate readings regardless of skin tone. The challenge of inaccurate readings for people with darker skin came to the fore with the COVID-19 pandemic as fingertip pulse oximeters emerged as a convenient method of monitoring for hypoxia at home and in clinics, but frequently overreported oxygen levels in the blood of people of color, leading to delayed treatment.
Shortages of medical devices were not particularly topical before the COVID-19 pandemic, but they have dotted the landscape in the past three years despite the U.S. FDA’s best efforts to manage such issues. The agency recently announced that tracheostomy tubes are now among the device types that are in a state of shortage, a problem created by a paucity of the raw materials used to manufacture these items.
