Drafting 510(k) Submissions Under New FDA Policies - 2012 & Beyond

This 90-minute 510(K) training will provide practical tips and tools (templates) for preparing regulatory marketing submissions that will ensure swift clearance of your Class II and Class III medical devices.

Why Should You Attend:

FDA has initiated substantial changes to the Premarket Notification “510(k)” process that significantly increase the data and documentation requirements for Class II medical devices. Very few manufacturers are aware of the practical changes that will be needed during design control and 510(k) submission process to ensure lengthy and expensive delays do not occur for their new products.

Areas Covered in the Seminar:

• Overview of the FDA Regulations pertaining to the development of Class II medical devices, including.
• Drafting 510(k) submission using new recommended practices by FDA.
• Guiding Class II medical device development teams in design control practices that will yield effective data to evidence ‘substantial equivalence' to your selected predicate device(s).
• Enhanced 510(k) manufacturing data requirements.
• Learn efficient methods to generate the type of safety and effectiveness information FDA now expects, including easy to implement “clinical literature review and compilation” practices; and How to write 510(k) submissions that ensure clearance in the shortest time possible;
• Legal writing tips designed to overcome FDA ODE reviewer comments and challenges of ‘non substantial equivalence' (NSE) to selected predicate device(s).
• Learn when you, the Regulatory Affairs professional, should ‘push back' and challenge FDA reviewer opinions regarding compliance with 510(k) regulatory requirements;
• Learn other legal and regulatory techniques that protect you and your employer from future enforcement actions (e.g., 483 inspection deficiencies, warning letters, coerced product recalls, etc) relating to recently cleared products.
• Tactical tools will be presented in the framework of an overall regulatory strategy so you can effectively communicate your plan to senior management, the development team, and most importantly, to government regulators. Templates, Checklists and other proven tools will be available for all participants to incorporate immediately in their own practice.
• Discussion of the most common flaws and pitfall in product development programs that increase the regulatory burden on a manufacturer under the new FDA 510(k) process. These include:
• Practical and immediate steps to take to dramatically reduce the cost of regulatory compliance for Class II/III devices.
• Long-term strategies to ensure an efficient product development program.

Who Will Benefit:

Individuals who will benefit include:

• Management and personnel from all departments who wish to remain abreast of key changes in FDA CDRH policies
• QA/QC/Compliance/Regulatory Affairs
• Engineering/R&D/Technical Services