Here’s a roundup of companies announcing clearances and approvals from the Food & Drug Administration and foreign regulatory agencies. Check out MassDevice’s compilation of the latest regulatory news for additional clearances and approvals.
- Plexus wins FDA clearance for hemorrhoid-prevention device
Plexus Biomedical Inc. was granted a new classification and approval from the Food & Drug Administration to market the first device clinically shown to help prevent external hemorrhoids during vaginal childbirth. The patented Hem-Avert Perianal Stabilizer supports the perianal region of the patient during labor and delivery. The device is completely external and will soon be available to physicians and hospitals nationwide. "Since there were not any competitive products or predicate devices that addressed delivery-induced hemorrhoids, the company conducted a prospective, randomized, multicenter clinical study to provide the clinical data necessary for the FDA to create a new classification for the device through its de novo 510(k) process." CEO David Blurton said in prepared remarks. Hemorrhoids associated with vaginal delivery are a frequent complication of childbirth and affect between 750,000 and 1,000,000 pregnant women in the U.S. every year.
- Sunquest wins ONC certification for latest EHR laboratory module
Sunquest Information Systems announced that Sunquest Laboratory version 6.4.2 is 2011/2012 compliant and was certified as an electronic health record module on Jan. 21 by the federal Certification Commission for Health IT (an Office of the National Coordinator for Health Information Technology Authorized Testing and Certification Body) in accordance with the applicable certification criteria adopted by the Secretary of Health and Human Services. The 2011/2012 criteria support the Stage 1 meaningful use measures required to qualify eligible providers and hospitals for funding under the American Recovery and Reinvestment Act. The ONC-ATCB 2011/2012 certification program tests and certifies that Complete EHRs meet all of the 2011/2012 criteria and EHR Modules meet one or more – but not all – of the criteria approved by the Secretary of HHS for either eligible provider or hospital technology.
- Quintiles central laboratory awarded accreditation to the International Standard for Quality Management
Quintiles’ laboratory in Marietta, Ga., received accreditation from the College of American Pathologists (CAP) 15189SM Accreditation Program. The Quintiles lab is one of only of a limited number of central labs in the U.S. to meet the rigorous requirements for medical laboratory quality and competence established by the International Organization for Standardization (ISO). With CAP 15189 accreditation, Quintiles has achieved a best practices standard in lab-related quality management systems, and is well-positioned to respond to the changing healthcare environment and demonstrate measurable quality to customers. CAP 15189 is a voluntary, non-regulatory accreditation to the ISO 15189:2007 Standard, which utilizes specific criteria, procedures and processes to determine laboratory technical competence. The program complements CAP accreditation and other quality systems by optimizing processes, strengthening quality standards, reducing institutional errors and risks and controlling costs.
- Ascom (US) Inc. achieves medical device quality compliance
Ascom (US) Inc. achieved ISO 9001 and ISO 13485 certification. ISO 13485 emphasizes meeting regulatory as well as customer requirements, risk management and maintaining effective processes, namely the processes specific to the safe design, manufacture and distribution of medical devices. Although ISO 13485 compliance is voluntary, it provides a framework for meeting medical device quality requirements in the international market. Compliance with ISO 13485 helps meet the requirements outlined in 21 CFR Part 820 for the Quality System Regulations (QSR) applicable to medical device manufacturers and importers.