Any business entity that is a manufacturer of finished surgical appliances, devices, biological products, instruments, equipment, or technology used in orthopedic indications, who is legal manufacturer of a product and holds regulatory responsibility for the product and is registered with their health authority (e.g. with the FDA), or manufactures an orthopedic product that may still be in development or in clinical trials is eligible for membership with OSMA. Contract manufacturers, consultants and individuals are not eligible for membership.
Benefits of Membership
As an OSMA company member, associates are invited to attend quarterly meetings, with the spring and fall meetings positioned in the Washington, D.C. area to accommodate FDA staff participation. All of the quarterly meetings are two day events, with one full day dedicated to the educational program and the second to serve as an OSMA business meeting. These meetings provide an opportunity for industry members to stay abreast of current issues and to enable a forum to discuss strategy and impactful actions that affect the regulatory environment.
The educational program is dedicated to current areas of interest to the membership and provides unique opportunities for member interaction with invited guests such as FDA, notified bodies and regulatory and industry representatives from across the globe. These meetings provide a standing forum for positive interactions and dialogue between industry and regulators to promote a common understanding of issues and an opportunity to work together on issues of importance to our industry and patients.
The business meeting is dedicated to task force updates to discuss ongoing activities of the organization, recognition of significant accomplishments and discussion of emerging regulatory issues affecting the Industry and the actions OSMA can take to address them. Reports of other professional organizations’ meetings such as ASTM, ISO, AdvaMed and the AAOS Orthopaedic Device Forum are also included.
The following OSMA task forces have been established and continue their work to address relevant topics impacting our industry:
- Advanced Manufacturing
- Class I Accessories
- Proposed Guidance and Regulations
- Endotoxin Testing
- Performance Goals