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Australian diagnostic device developer ResApp Health has entered into a $74 million purchase deal with Pfizer, which will help the drugmaker expand into digital health products. Read More
In the latest in a seemingly endless series of FDA warning letters directed at unapproved COVID-19 products, the agency cited a Michigan-based company about claims it has been making online for its nasal spray. Read More
Sensory Cloud of Boston, Mass., has received a warning letter from the FDA for promoting an unapproved saline spray device as a COVID-19 treatment. Read More
The FDA has released two final guidances outlining a new product review pathway for developers of orthopedic fracture fixation plates and surgical suture devices. Read More
A good corrective and preventive action (CAPA) report tells a company’s compliance story for four specific audiences: current employees, future employees, regulators and possibly lawyers, if a lawsuit eventually results from a product problem. Read More
Each corrective and preventive action (CAPA) investigation should start with a strategy meeting. The lead investigator, who is typically the head of quality assurance, must determine whether the meeting should be formal or informal and what it should accomplish. The lead investigator also must decide who should participate. To maximize an investigation’s effectiveness, the company should gather everyone who understands the situation, including both high-level experts and frontline staff. Participants might include individuals from engineering, R&D, laboratory, production or QA. Certainly, the type of incident or deviation will help dictate attendance. Read More
Natera’s Prospera lung donor-derived DNA test has shown positive results in a study assessing rejection and lung-function injury in transplant patients. Read More
When examining submissions for approval or clearance of device software, the FDA will carefully assess whether it has adequate cybersecurity, the agency said in a draft guidance released yesterday. Read More