The U.S. FDA said it intends to resume some inspections of regulated domestic sites as of the week of July 20 after suspending routine surveillance inspections in March due to the COVID-19 pandemic. The agency said it has monitored the state and local determinations regarding reopening of business operations and has applied a rating system to determine which drug, device and biologic manufacturing sites to establish which sites are safe for surveillance audits. The FDA will announce these inspections in advance to ensure the safety of the agency’s field staff, although operators of tobacco-related sites will not be notified in advance.
The FDA has posted a draft guidance that would update a standing guidance for investigations into device-based treatment of benign prostatic hyperplasia (BPH). The scope of the draft encompasses four product codes, including KNS (endoscopic electrosurgical instruments) and NOY (embolic agents), and includes updates to sections on non-clinical testing. The draft recommends that animal studies include gross and histological examination of treatment areas by a blinded pathologist for items such as photomicrographs of histopathological sections, and offers specific suggestions for the use of thermotherapy and permanent prostatic stents. Potential challenges to human studies such as the subjectivity of lower urinary tract symptoms can be addressed by the use of a randomized, controlled trial, and the draft said that transurethral resection of the prostate is still the gold standard for surgical treatment. The draft would update the existing guidance on issues such as primary and secondary effectiveness endpoints, such as damage to the bladder floor, sphincters and the rectum. There are also recommendations for patient selection criteria and post-treatment evaluations. The FDA is taking comment through Sept. 14 under docket number FDA-2020-D-1118.
Insightec, of Miami, said it has achieved complete Medicare coverage across all 50 U.S. states for MR-guided focused ultrasound treatment of essential tremor that is refractory to medical management. The company noted that the company worked closely with seven Medicare administrative contractors over the past 18 months to achieve national coverage, adding that 22 independent members of the Blue Cross Blue Shield Association also cover the treatment.
The U.S. Agency for Healthcare Quality and Research (AHRQ) said it is interested in supplemental evidence on the use of continuous positive airway pressure (CPAP) devices for treatment of obstructive sleep apnea in Medicare beneficiaries. The request is related to an AHRQ effort to answer questions such as which measures of apneas and hypopneas have changed over time, and how respiratory disturbance events are defined. AHRQ is accepting feedback through Aug. 13, which can be emailed to firstname.lastname@example.org.
The FDA posted a list of newly issued and reissued emergency use authorizations (EUAs) for certain medical devices in response to the COVID-19 pandemic. The list includes a large number of diagnostics and other tests, respirators and sterilization systems. This entry at the Federal Register also includes an explanation for the reissuance of existing EUAs.
Edwards Lifesciences Corp., of Irvine, Calif, said it has reached an agreement with Abbott Laboratories, of Abbott Park, Ill., to settle all outstanding patent disputes between the companies related to transcatheter mitral and tricuspid valve repair devices. The 10-year agreement forbids any future such litigation, Edwards said, adding that any related injunctions will be lifted. The July 13 press release did not specify the amount of the one-time charge the company will incur to cover the cost of the settlement, a cost that will be incurred for the quarter ending June 30. Edwards also said it is liable for royalty expenses through May 2024. Abbott’s statement was no more forthcoming on the details of the settlement, which are confidential.