EMA Answers Industry Questions on MDR/IVDR
The European Medicines Agency released a new question and answers document on its Medical Devices Regulation and In Vitro Diagnostic Regulation in an attempt to answer mounting questions from industry. Read More
Court Says Methods for Appointing PTAB Judges Are Unconstitutional
In a case that involves two medical device companies, the Federal Circuit Court of Appeals has ruled that the method for appointing Patent Trial and Appeal Board’s… Read More
Devices News
FDA Offers Advice on Drug Master Files for CDER-Led Combination Products
Sponsors of CDER-led drug-device combination products that include electronics or software should include specific technical information in their Type V drug master files, the FDA said in a draft guidance. Read More
Senators Voice Concerns About FDA’s Software Precertification Program
Three Democratic senators raised new concerns about the FDA’s digital health pre-certification program and pressed the agency for more clarity. Read More
Senators Press FDA on ‘Progressive Approval’ for Medical Devices
Two senators pressed the new acting FDA Commissioner Brett Giroir and CDRH Director Jeffrey Shuren in a Nov. 4 letter on the agency’s proposal to create a “progressive approval” pathway for medical devices. Read More
Contract Manufacturer Cited for Validations, Nonconforming Product
Lax process validation, inadequate control of nonconforming product and failure to implement CAPA procedures were a few of the concerns the FDA highlighted during an inspection of Mark Two Engineering’s Miami Lakes, Florida facility. Read More
