The U.S. FDA posted a draft guidance providing select updates for biocompatibility testing of devices that come into contact with human skin. The draft proposes that for some types of materials, such as polymers and fabrics, the risk of biocompatibility issues is very low, and thus some procedures, such as purchasing controls, can be used in lieu of animal testing to ensure biocompatibility. Among the materials within the scope of the proposed update are synthetic polymers (including cured epoxy adhesive), and fabrics (such as those manufactured from polyurethane). Among the materials excluded from the update are those manufactured from in-situ polymerizing materials and those that come into contact with breached or compromised skin surfaces. The current final guidance posted in 2016 remains in force until the draft is finalized. The agency is taking comment through Dec. 14 at docket number FDA-2013-D-0350.
The FDA also published a final guidance for technical considerations for nonclinical assessment of devices containing nitinol, wrapping up a draft that emerged in April 2019. The final guidance recommends that manufacturers document when the composition of the nitinol conforms to a specific reference standard, such as ASTM F2063, or describe the composition and specific properties if the material is not processed per an existing standard. The manufacturing method should be described by means of a high-level flowchart identifying the materials and processes employed from handling of raw materials to the production of the finished product. Device records should document whether the nitinol is manufactured with either pseudoelasticity or shape memory in mind, and the phase transformation temperatures specific to the mechanical properties imparted to the material. Mechanical testing is ordinarily conducted under displacement control of the finished device, although alternative methods, such as pressure control with displacement monitoring, can be used when the justification for doing so is documented. The guidance also addresses computational strain/stress analysis, corrosion and pitting/corrosion testing, and nickel iron release.
FDA taking adcomm nominations
The FDA said it is seeking nominations for two advisory committees, the device good manufacturing practices (GMPs) advisory committee and several of the panels under the medical devices advisory committee. There are four openings for the device GMP advisory committee, all of which are needed in short order. The circulatory systems devices advisory committee needs a single new member by July 1, 2021, while the clinical chemistry/toxicology advisory panel needs five new members, two immediately and the remaining three by March 1, 2021.
HHS, DoD ink deal with Cue Health
The U.S. Department of Health and Human Services announced that it and the Department of Defense have awarded a grant of $481 million to Cue Health Inc., of San Diego, that the company will use to expand production of a cartridge-based point-of-care test for the COVID-19 pandemic. The agreement calls on Cue to ramp up production of the 20-minute test to 100,000 kits per day by March 2021, a capacity the company must demonstrate by delivering 6 million tests and 30,000 instruments to the U.S. government by an unspecified date. The test can turn around results of RNA detection in 20 minutes with the help of a swab wand for sampling from the “lower part of the nose,” HHS said.
NTAP town hall set for Dec. 15-16
The U.S. Centers for Medicare & Medicaid Services (CMS) said it will hold the annual town hall for the new technology add-on payment (NTAP) program Dec. 15-16, 2020. The town hall will be held virtually this year due to the COVID-19 pandemic, and the agency noted that the second day may not be necessary, depending on the volume of submissions. The dial-in number and the URL for a webcast will be posted at a later date not specified. Parties interested in presenting at the event must register with the CMS by Nov. 23. Applications discussed at the meeting will be eligible for the fiscal year 2021 Medicare inpatient prospective payment system.