The U.S. FDA has posted a draft guidance for requesting agency feedback on combination products, which describes interactions that can take place via formal pre-submission mechanisms or by combination product agreement meetings, or CPAMs. The guidance was issued in response to Section 3038 of the 21st Century Cures Act, and the agency said it is in the process of operationalizing the procedures related to submission and receipt of a CPAM request. Such requests should be filed with both the Office of Combination Products and the product jurisdiction officer at the presumed lead center. The agency is taking comment through Feb. 24, 2020, under docket number FDA-2019-D-4739.
The FDA finalized the April 26, 2019, draft guidance for the content and format of non-clinical bench testing of medical devices in premarket submissions, the scope of which includes both manufacturer and third-party testing. The final guidance recommends that test report summaries be provided in the submission’s executive summary or in a separate document provided with the premarket filing. Tests should be described with test methods, sample sizes and a list of any standards used in evaluating the results of testing. Predefined pass/fail criteria also should be listed when applicable, and the locations of complete test reports, when needed, should be listed. The report also should describe any deviations from the test protocol and a description of activities undertaken to evaluate the impact of those deviations on the results.
The International Trade Commission (ITC) has affirmed an administrative law judge’s finding that that 10X Genomics Inc., of Pleasanton, Calif., has infringed three patents held by Bio-Rad Laboratories Inc., of Hercules, Calif. The ITC issued a limited exclusion order and a cease-and-desist order against 10X that prohibits the unlicensed importation of the infringing microfluidic devices. However, 10X will be allowed to continue providing the devices to those who are engaged in ongoing research efforts as long as 10X is in compliance with ITC’s remedial orders.
The FDA said the class I recall of the Sentiva vagus nerve stimulator (VNS) system by London-based Livanova plc is due to a reset error that can terminate VNS therapy. The recall affects more than 2,900 units distributed in the U.S. in 2019 on the basis of 14 reports of unexpected reset errors. The FDA is reviewing the mitigations proposed by the company. The Sentiva is approved for the treatment of epilepsy and depression.