In the United States, all medical devices’ safety and effectiveness are regulated by the Food and Drug Administration (FDA). The regulatory pathways for medical devices – 510(k) clearance and PMA (Pre-Market Approval) – are built on the following risk classifications:
Class I with exceptions – low-risk products that do not need to have a quality management system or meet certain regulatory requirements.
Class I without exceptions – low-risk medical devices need to meet all applicable requirements and have a quality management system.
Medical devices Class II – devices with special controls for “labelling, guidance, tracking, plan, performance standards, and post-market observation”.
Class III devices with/without premarket approval – products that continue or support human life, are embedded, or present a significant risk of illness or injury.
Most Class I medical devices can be self-enrolled, but a large amount of Class II devices require a 510(k) premarket notification submission. And for Class III medical devices, a PMA submission is often required.
Manufacturers must follow Current Good Manufacturing Practice (CGMP) regulations when developing their medical devices. The FDA examiners use the CGMP regulations to decide whether a manufacturer has the facilities and know-how to deliver and pack their product. Additionally, all medical devices must have a unique device identifier (UDI) that is understandable by both machines and humans.
At BAI we do In-depth analysis to identify and address gaps in your processes, ensuring a robust foundation for compliance. Through review of client-specific technical documentation we ensure we meet mandatory standards and enhance your document integrity.
• Gap Analysis
• Preparation of Dossier in line with the US FDA 510K requirements.
• Preparation of the Quality System Manual, Procedures and Formats in line with the US FDA 510K requirements.
• Documenting the design history file.
• Develop and deliver awareness programs for employees.
• Provide specialised training for QARA individuals responsible for implementing controls.
• Promote a culture of quality within the organisation.
• Implementation of 21 CFR 820 requirements as applicable.
• Getting the testing completed as per applicable requirements.
• Handhold wherever required.
• Internal implementation reviews and readiness.
• Applying for A Pre-sub meeting with US FDA.
• Completing the gaps between already prepared dossier and submitting the 510K submission to US FDA through eSTAR web portal.
• US FDA performs preliminary review (RTA). This generally takes 15 working days from the date of assignment of 510K reviewer.
• The response to RTA to be prepared and submitted to US FDA. US FDA gives 180 Days to resolve these issues.
• Once this is accepted, US FDA will begin substantive review and provide AINN requirements or a substantive review deficiency list.
• Once the response to that deficiency list or AINN is completed, US FDA will perform the final review completion and issue the decision of SE (substantially equivalent to the equivalent / similar device) or NSE (non-substantially equivalent to the predicate/similar device).
• Trainings, Audits & Technical guidance
• Regular risk assessments, audits, and updates to QMS processes and procedures
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