FDA Extends Compliance Dates for Class I & Unclassified Devices
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In 2020, the US FDA issued a large number of guidance papers, the bulk of which were in response to the COVID-19 pandemic. All records, including Q&A documents, were revised on a regular basis to reflect the Agency’s position during the pandemic and the effect of the pandemic on regulatory functioning. Several enforcement policies for ventilators, sterilizers, disinfectant devices, personal protective equipment (PPE) such as gowns, gloves, facemasks, and respirators, clinical electronic thermometers, infusion pumps, various remote patient monitoring devices and software, bioburden reduction systems, Viral Transport Media (VTM), and others have been released to facilitate reduced hospital visits, reduced human contact, and to meet regulatory requirements.
For Class I and unclassified devices, the UDI implementation dates for standard date formatting, UDI labeling, GUDID data submission, and direct marking standards have been extended until September 24th , 2022.
To help stakeholders understand and comply with the criteria, guidance on various ongoing applications has been published. General guidance documents and recommendations on biocompatibility testing criteria for medical devices, as well as specific safety and efficiency requirements for medical electrical equipment, have been published in preparation for the pilot program’s implementation (ASCA). Guidance on recommendations for dual 510(k) and CLIA applications, as well as CLIA waiver applications for IVDs, were released to help with the CLIA application. The 510(k) third-party evaluation program guidance was also issued.
Medical Device specific guidelines have been issued for magnetic resonance receive only coils, spinal plating systems, orthopedic non-spinal metallic bone screws and washers, cutaneous electrodes for recording purposes, and traditional Foley catheters, in addition to the performance requirements for protection and performance-based pathway adopted by the US FDA in 2019. Pre-Market Notification (510(k)) submissions for bone anchors, electrosurgical devices for general surgery, and device-specific documentation on micro needling devices, prescription point-of-use only blood glucose monitoring systems, OTC self-monitoring blood glucose systems, saline, silicone gel, and alternative breast implants were also released.
The guidelines for conducting non-clinical assessments of Nitinol-containing medical devices, as well as breast implant labeling recommendations, were also published.
The US Food and Drug Administration (FDA) recently issued ten (10) draught guidelines on electromagnetic compatibility of medical devices, as well as select updates for biocompatibility of devices that come into contact with intact skin. Guidance for submitting a Pre-Market Notification (510(k)) for peripheral percutaneous transluminal angioplasty and specialty catheters, peripheral vascular atherectomy devices, and arthroscopy pump tubing sets intended for multiple patient use; clinical and non-clinical investigation of devices used in Benign Prostatic Hyperplasia (BPH); labeling guidance for laparoscopic power morcellators; Soft (hydrophilic) everyday wear contact lenses provide performance requirements for safety and performance-based pathways.
Device manufacturers will have to reassess their enforcement status and prepare for remediation activities after the final publication of these guidance papers.
Interim orders were issued by Health Canada and were revised on a regular basis to make it easier to import and sell medical devices needed to deal with the COVID-19 pandemic and the clinical trials associated with it. A new guidance on post-market surveillance (PMS) and risk management was released in accordance with Health Canada’s focus area, allowing for increased scrutiny and vigilance of devices entering the Canadian market.
CATEGORY: Medical Devices, Regulatory Affairs
Keywords: Medical Devices, US FDA, personal protective equipment (PPE), Viral Transport Media (VTM), Unique Device Identification UDI, Accreditation Scheme for Conformity Assessment ASCA, 510k, Clinical Laboratory Improvement Amendments CLIA, In-vitro Diagnostic Medical Device IVD, OTC, post-market surveillance (PMS).
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