Devices
FDA, working with Health Canada and the UK’s Medicines and Healthcare Products Regulatory Agency, has identified 10 guiding principles to inform the development of Good Machine Learning Practice (GMLP). An FDA statement says the principles will “help promote safe, effective, and high-quality medical devices that use artificial intelligence
Devices
FDA says it has taken several new actions to strengthen breast implant risk communications and help those who are considering breast implants to make informed decisions. An agency notice says it: * issued orders restricting the sale and distribution of breast implants to help ensure that patients considering implants are provided
Devices
CDRH has published two lists of proposed guidances for FY 2022 plus a list of previously-issued final guidances for which the Center wants feedback on whether they should be revised or withdrawn. The document divides the proposed FY 2022 guidances into an A list (six final guidance topics and
Drugs
Three Sidley attorneys say a new FDA final rule amending the agency’s regulations defining intended use opens many consumer products without therapeutic claims to regulatory oversight as drugs or medical devices. In their analysis, the attorneys say the rule provides that the agency can find a product subject to
Devices
The Pew Charitable Trusts says Congress should pass legislation to increase the transparency of the market for laboratory-developed tests (LDTs) and authorize FDA to review the tests based on their risk to patients. In an online report, Pew says that because LDTs are not centrally registered or tracked, no
Devices
Eyenovia has received a complete response letter on its NDA for MydCombi (tropicamide and phenylephrine), indicated for in-office pupil dilation, because the agency had reclassified the drug as a drug-device combination product. The reclassification was prompted by FDA’s recent court loss (see earlier story) in Genus Medical
Devices
CDRH has created a patient resource Web page to provide information about endometrial ablation for heavy menstrual bleeding, including the procedure's benefits and risks. The page covers approved endometrial ablation devices for premenopausal patients with heavy menstrual bleeding due to benign causes. The devices use various methods, such
Drugs
FDA has approved Biofrontera’s BF-RhodoLED XL, a red-light source for photodynamic therapy (PDT) and its combination use with the company’s Ameluz (aminolevulinic acid hydrochloride) gel for treating mild and moderate actinic keratoses on the face and scalp. The PDT lamp is designed to illuminate large areas
Devices
FDA has granted de novo premarket approval to Luminopia for its Luminopia One as a prescription therapy to improve vision in children with amblyopia, also known as lazy eye. The company says Luminopia One is indicated for improving visual acuity in children with amblyopia aged 4-7, associated with anisometropia
Devices
FDA has denied a 4/30 Stryker Medical petition seeking a Class 2 510(k) exemption for powered patient transport, all other powered patient transport. The FDA denial letter says the devices are motorized units used to mitigate mobility impairment caused by injury or disease by moving a person from
Devices
FDA says Cook Medical issued a 10/8 recall of its transseptal needle and transseptal needle with catheter. The recall covers all unexpired lots for both products, an agency statement says. The needles were recalled due to complaints of rust on the products. The notice says that the use of
Devices
A 6/3-7/15 FDA inspection at Magnolia Medical Technologies, Seattle, WA, found Quality System regulation violations in the firm’s work as a specification developer for the Steripath Gen 2 blood collection system. A 9/17 Warning Letter says specific violations were: * failing to establish and maintain adequate
Devices
FDA will accept comments for 90 days on a proposed rule to establish a regulatory category for over-the-counter (OTC) hearing aids and to make related amendments to update the hearing aid regulatory framework. In the proposed rule, FDA says it will: * define OTC hearing aids and establish applicable
Devices
FDA has cleared an SPR Therapeutics 510(k) for a broader indication for use for its Sprint Peripheral Nerve Stimulation (PNS) System. The device’s previous clearance limited its use to the back and extremities, but the new indication allows it to also be used in areas of the head,
Devices
FDA has granted HistoSonics a breakthrough device designation for its novel sonic (acoustic energy) beam therapy histotripsy and its use to mechanically destroy and liquefy tissue in the liver without incisions, ionizing radiation or heat. The designation was made based on early clinical and pre-clinical results suggesting that histotripsy
Devices
FDA has provided an update on its ongoing monitoring of heater-cooler devices and the risk of nontuberculous mycobacteria (NTM) infections in patients who have undergone cardiothoracic surgery using the devices. Two heater-cooler manufacturers (CardioQuip and Gentherm Medical) announced voluntary recalls to provide updated labeling with interim mitigation strategies
Devices
FDA has decided to regulate novel robot assisted surgery (RAS) devices for specific indications rather than the previous tool-type indication they were cleared under in the past. Writing in a new FDALawBlog post, Hyman, Phelps & McNamara attorneys Jeffrey K. Shapiro and Allyson B. Mullen take FDA to task
Devices
CDRH director Jeffrey Shuren and Office of Product Evaluation and Quality director William Maisel say the Center’s Digital Transformation Initiative is strengthening the premarket review program. Writing in an online FDA Voices post, Shuren and Maisel say that building a robust infrastructure within FDA and efficient external data interfaces
Devices
FDA has denied three 2017 and 2018 petitions submitted by Chul-Hi Park, Ph.D., Seoul, Korea, asking the agency to prevent clearance for marketing any specific devices without proof of safety and effectiveness and retroactively regulating formerly cleared specific devices to provide similar data on safety and effectiveness. The
Devices
Sens. Chuck Grassley (R-IA) and Elizabeth Warren (D-MA) are calling on FDA to quickly issue new regulations for over-the-counter hearing aids. In a 10/12 letter, they say their 2017 Over-the-Counter Hearing Aid Act “removes outdated regulations blocking consumer access to affordable hearing aids
Devices
FDA says the 9/2 Abbott Molecular recall of its Alinity m SARS-Cov-2 AMP kit and Alinity m Resp-4-Plex AMP kit is Class 1. An agency notice says 187 software installations are being corrected to automate testing with the 9,964,224 distributed tests for Alinity
Devices
FDA says it agrees with priority recommendations made by Booz Allen Hamilton in an independent assessment of the CDRH Covid-19 response in terms of emergency use authorization (EUA) of Covid-19 tests. For its work, Booz Allen Hamilton reviewed primary documents and conducted internal and external stakeholder interviews to