510(k) Consultants

I3CGlobal Expands 510(k) Consulting Support for Medical Device Manufacturers Entering the US Market

I3CGlobal, a regulatory consulting firm working across FDA, EU MDR/IVDR, and UKCA/MHRA pathways, has expanded its business tie-up with the MEDNOVA team of 510(k) consultants to support medical device and IVD manufacturers preparing premarket submissions for the US market. The move comes as manufacturers report longer review cycles and more frequent Additional Information (AI) requests from FDA reviewers over the past two submission cycles.

Helping manufacturers navigate the 510(k) pathway

The 510(k) process requires manufacturers to show their device is substantially equivalent to a legally marketed predicate device, but predicate selection, substantial equivalence comparisons, and the eSTAR submission format trip up a lot of first-time applicants. I3CGlobal's consultants work directly with manufacturers on predicate research, device classification, performance testing strategy, and full eSTAR preparation, aiming to reduce the back-and-forth that often comes with the FDA's Additional Information requests.

Getting the predicate comparison right at the start saves months later," said a senior regulatory consultant at I3CGlobal. "Most delays we see come from gaps that could have been caught during initial classification, not from anything that happens later in the review."

Support across device types and company sizes

The expanded team covers a range of device categories, including diagnostic instruments, surgical tools, and software-based devices (SaMD). I3CGlobal works with both early-stage companies submitting their first 510(k) and established manufacturers managing portfolios of existing clearances that need updates or new indications. Services include gap assessments against current FDA guidance documents, technical file preparation, biocompatibility and performance testing strategy, and direct liaison with the FDA during the review cycle.

The team also supports manufacturers who received an FDA refuse-to-accept (RTA) decision or an AI request on a prior submission, helping identify what went wrong and rebuilding the submission package before resubmission.

Conclusion

With FDA continuing to update its guidance documents and eSTAR requirements, manufacturers are increasingly looking for consultants who can keep pace with these changes while managing submission timelines. I3CGlobal's expanded 510(k) team is positioned to support that demand, offering manufacturers a single point of contact from pre-submission planning through to clearance, regardless of device classification or company size.

I3CGLOBAL US Inc.
1914, J N Pease Pl, Charlotte, North Carolina, 28262
Mr. Binoy Joese
enquiry@i3cglobal.com

I3CGlobal is a regulatory consulting firm supporting medical device and IVD manufacturers across FDA 510(k), EU MDR/IVDR, UKCA/MHRA, and ISO 13485 pathways. With teams spanning multiple countries, the firm provides services including premarket submissions, technical documentation, clinical evaluation, and quality management system support for companies of all sizes.

This release was published on openPR.