Devices
CDRH has released a list of prioritized guidance documents that it intends to publish this fiscal year (FY 2021). Final guidance topics the Center intends to publish include Surgical Staplers, Safer Technologies Program for Medical Devices, Clinical Decision Support Software, Device-Specific Criteria Guidance for Safety and Performance Based Pathway
FDA Policy/General
Federal Register notice: FDA is announcing its Quality Management Maturity for Finished Dosage Forms Pilot Program for domestic drug product manufacturers of prescription and over-the-counter drug products. The pilot is intended to gain insight from third-party assessments of a manufacturer’s quality management system to inform future
Devices
CDRH has released a series of videos highlighting the progress the Center has made to date with implementing the current medical device user fee program. The program has just ended its third year, and the videos include performance goals met, building CDRH’s total product lifecycle regulatory approach, accessing and
FDA Policy/General
Federal Register notice: FDA is announcing a requirement for electronic submissions to be submitted using the Electronic Common Technical Document Module 1 U.S. Regional DTD Version 3.3 beginning 3/1/2022. To view the notice, click here.
Drugs
CDER says it is starting two new pilot programs to gain insight from third-party assessments of a manufacturer’s quality management system to inform future development of an agency rating system. The Center says a rating system would characterize quality management maturity and incentivize investment in quality manufacturing. The
FDA Policy/General
Federal Register notice: FDA makes available a final guidance entitled Technical Considerations for Non-Clinical Assessment of Medical Devices Containing Nitinol. The document provides the agency’s current thinking on technical considerations specific to devices using nitinol due to the unique properties of nitinol. It is also intended to provide
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled Select Updates for Biocompatibility of Certain Devices in Contact with Intact Skin. The document discusses the agency’s current thinking on the type of biocompatibility information that should be provided in a premarket submission for certain devices made from
Devices
University of Oxford researchers say their review of comments on a proposed FDA regulatory framework for modifications to artificial intelligence and machine learning-based software as a medical device found that 63% of the comments came from parties with financial ties to industry and 86% of comments did not cite
Drugs
FDA has cleared a See-Mode Technologies 510(k) for its Augmented Vascular Analysis (AVA), a medical artificial intelligence software for automated analysis and reporting of vascular ultrasound scans. “AVA uses deep learning, text recognition, and signal processing technologies to assist clinicians in interpreting and reporting vascular ultrasound studies — typically
Biologics
CNN says a source familiar with the AstraZeneca Covid-19 vaccine trial told the network that the company took until last week to get adverse event safety information to FDA, which placed a 9/9 clinical hold on the vaccine trial after a participant became ill with a neurological condition.
Drugs
FDA has been redacting the dietary supplement product names in many serious reports of adverse events voluntarily submitted to the Center for Food Safety and Applied Nutrition Adverse Event Reporting System (CAERS) database. Consumer Reports says the agency often puts “Exemption 4” in the database column where the product name
FDA Policy/General
The Justice Department says Merit Medical Systems, South Jordan, UT, has agreed to pay $18 million to resolve allegations that it caused the submission of false claims to government healthcare programs by paying kickbacks to doctors and hospitals to induce use of its products. A department statement says the company
Devices
FDA has cleared a Livmor 510(k) for the Livmor Halo AF Detection System, a physician-prescribed wearable device that provides continuous monitoring of pulse rhythms for the detection of atrial fibrillation (AF), on demand during the day and automatically overnight. Continuous monitoring can significantly enhance the detection of paroxysmal
Drugs
An FDA drug safety communication warns that the use of nonsteroidal anti-inflammatory drugs (NSAIDs) around 20 weeks or later in pregnancy may cause rare but serious kidney problems in an unborn baby. The notice says the use of NSAIDs can lead to low levels of amniotic fluid surrounding the
Devices
FDA has made available a final guidance entitled Testing for Biotin Interference in In Vitro Diagnostic Devices. The document provides recommendations on testing for interference by biotin on the performance of in vitro diagnostic devices. It is intended to help device developers and clinicians understand how the agency recommends biotin
FDA Policy/General
Almost two months ago, FDA commissioner Stephen Hahn removed his newly appointed chief spokeswoman Emily Miller in the wake of his controversial remarks exaggerating the efficacy of convalescent plasma for Covid-19 at an 8/23 White House press conference. It is now being discovered that Miller never left the
FDA Policy/General
Federal Register notice: FDA is requesting nominations for voting members to serve on its Device Good Manufacturing Practice Advisory Committee and the Medical Devices Advisory Committee panels. The annual notice is intended to provide an opportunity for patients, representatives of patients, and medical device sponsors that may be the subject
Devices
CDRH has released a draft guidance entitled Select Updates for Biocompatibility of Certain Devices in Contact with Intact Skin. The document proposes select updates to FDA’s current thinking on the type of biocompatibility information that should be provided in a premarket submission for certain devices made from common polymers
Drugs
In a 2-1 decision, the Federal Circuit Court of Appeals recently ruled in GSK v. Teva that ANDA and 505(b)(2) labeling carveouts induce patent infringement, rendering any generic sponsors who relied on a section viii statement for a method-of-use patent vulnerable to patent litigation. Attorney
Devices
FDA has published a guidance, Technical Considerations for Non-Clinical Assessment of Medical Devices Containing Nitinol, with the agency’s current thinking on technical considerations specific to devices using nitinol due to its unique properties. The document says nitinol is commonly used in the medical device industry. Device manufacturers have
Drugs
AbbVie says that an FDA draft guidance, Acute Myeloid Leukemia: Developing Drugs and Biological Products for Treatment, would be most useful if the agency modified it to include instructions on analysis of best/overall response in the presence of post-study treatment. The company comment letter says, for example, the
Devices
FDA has issued an immediately-in-effect guidance, Enforcement Policy for Modifications to FDA-Cleared Molecular Influenza and RSV Tests During the Coronavirus Disease 2019 (Covid-19) Public Health Emergency, to provide a policy to help expand access to certain FDA-cleared molecular assays intended for detection and identification of