The FDA GroupThe FDA Group 510(k) Strategy and Submission Services

The FDA Group 510(k) Strategy and Submission Services guide medical device makers from regulatory strategy through eSTAR submission and post-clearance support. Consultants determine classification and predicate devices, prepare pre-submissions and Q-subs, compile submissions, manage FDA interaction and review responses, and advise on labeling, biocompatibility, software, EMC, and performance testing.

The team includes former FDA reviewers and industry veterans who have completed hundreds of submissions across device classifications, serving startups through global enterprises through consulting projects and staff augmentation engagements.