Services

Product Development and Authorization

  • Determine least burdensome regulatory pathways

  • Develop tailored regulatory strategy for pre-submissions, IDEs, 510(k)s, De Novos, Breakthrough Designations, 513(g)s, RFDs, etc.

  • Perform regulatory gap assessments and identify potential risk and mitigation strategies

  • Determine when to submit a 510(k) for a change to an existing device

  • Draft letters to file

  • Counsel on Small Business Designations

  • Guide clients through the Registration and Listing process (21 CFR Part 807)

  • Advise on labeling and promotional, including compliance with the Unique Device Identification (UDI) regulation (21 CFR Part 801 Subpart B and 21 CFR Part 830)

  • Draft and submit allegations of regulatory misconduct

Compliance and Quality

  • Prepare clients for pre-market and post-market inspections

  • Support audits and ensure compliance with Quality Management System Regulation (21 CFR Part 820)

  • Counsel on Medical Device Reporting obligations (21 CFR Part 803)

  • Advise on Recalls (21 CFR Part 810) and reports of Corrections and Removals (21 CFR Part 806)

  • Respond to FDA Inspectional Observations (Form FDA-483) and Warning Letters, including reviewing and drafting Standard Operating Procedures (SOPs) and accompanying documentation

  • Prepare and submit initial and annual reports on radiation safety testing of laser and laser light show products

  • Conduct internal investigations to investigate complaints, mistakes, and potential problems

Reviews

“You have done a great job capturing, analyzing, and summarizing the agency’s work in a way that is always enlightening.”

— Deputy Ombudsman, FDA re RFD analysis

“Thank you very much for your work. It is very thorough.”

— Former Client re 483 response

“Thank you for the feedback. I incorporated it all. It was very helpful. Great feedback.”

— Former Client re 510(k) submission