FDA 510(k) Glossary · regulatory

Regulatory Consultant

A regulatory consultant (or regulatory affairs consultant) is a firm or individual that manages the 510(k) submission process on behalf of a medical device manufacturer - coordinating technical documentation, predicate strategy, and FDA communications. The 510k Database dataset identifies the consultant for 11,050 submissions where the correspondent differs from the applicant.
Dataset Insight - 510k Database (166,200 records, 1980–2025)
11,050 submissions in the dataset identify a regulatory consultant as correspondent. Top firms: Hogan Lovells US LLP (182), Regulatory Technology Services (167), RQM+ (69).

Definition

In the FDA 510(k) regulatory context, a regulatory consultant (also called a regulatory affairs consultant or contract regulatory organization) is an external firm or individual engaged by a medical device manufacturer to manage the 510(k) premarket notification submission process. The consultant typically acts as the correspondent - the primary point of contact with the FDA throughout the review process.

Role of the Regulatory Consultant

  • Predicate strategy - identifying and evaluating suitable predicate devices for the substantial equivalence argument.
  • Technical documentation - preparing the 510(k) submission package, including device description, performance testing data, and labeling.
  • FDA correspondence - managing communications with the FDA review team throughout the submission process.
  • Response to AI (Additional Information) - preparing responses when the FDA requests additional data during review.
  • Post-market strategy - advising on regulatory compliance and modification submissions.

Why Manufacturers Hire a 510(k) Regulatory Consultant

Regulatory consultants are most commonly engaged when:

  • No in-house RA team - startups and smaller medtech companies typically lack internal regulatory affairs expertise.
  • Novel device categories - first-time submissions in unfamiliar FDA panels benefit from specialist experience.
  • Previous NSE determination - manufacturers with a prior Not Substantially Equivalent determination often bring in external expertise for the resubmission.
  • AI/SaMD submissions - SaMD and PCCP-enabled devices require regulatory strategy beyond standard hardware submissions.
  • International manufacturers - companies outside the U.S. entering the FDA market frequently rely on U.S.-based regulatory consultants for FDA communications.

Search 510(k) submissions by regulatory consultant in the database to identify firms active in specific device categories.

Top Regulatory Consultants in the Dataset

Based on 510k Database records enriched from FDA accessdata.gov, the following firms appear most frequently as correspondents (distinct from the device manufacturer/applicant) across all published submissions:

FirmSubmissions
Hogan Lovells US LLP182
Regulatory Technology Services, LLC167
Shanghai SUNGO Management Consulting Co., Ltd.127
Feiying Drug & Medical Consulting Technical Services103
Mcra, LLC101
Shanghai Truthful Information Technology Co., Ltd.100
Third Party Review Group, LLC81
RQM+69
Mid-Link Consulting Co, Ltd.61

Note: consultant identification is based on correspondent field differing from applicant. Some entries may reflect regulatory representatives rather than independent consulting firms. Three of the top 10 firms are China-based, reflecting the volume of Chinese manufacturers seeking FDA clearance.

How Consultants Are Identified in the Dataset

The 510k Database extracts the correspondent field from individual FDA 510(k) submission pages on accessdata.fda.gov. When the correspondent differs from the applicant (the device manufacturer), the correspondent is flagged as the regulatory consultant. This enrichment is available for records processed through the FDA data enrichment pipeline.

Dataset Insights

MetricValue
Records with consultant identified11,050
Share of enriched records~6.6% of total dataset
Most active consultant (submissions)Hogan Lovells US LLP (182)
Data sourceFDA accessdata.gov (extracted)

Search 510(k) submissions by regulatory consultant

Related Terms

510(k) Premarket Notification - Predicate Device - Substantial Equivalence - Third-Party Review - Not Substantially Equivalent

Frequently Asked Questions

A regulatory consultant manages the 510(k) submission process on behalf of a medical device manufacturer. Responsibilities include predicate device identification, technical documentation preparation, substantial equivalence argumentation, correspondence with the FDA, and response to additional information requests. Consultants are identified in 510(k) submissions when the correspondent field differs from the applicant.

Manufacturers - particularly smaller companies and startups without in-house regulatory affairs teams - often engage regulatory consultants for 510(k) submissions. Consultants are also used for complex submissions, new product categories, submissions after prior NSE determinations, or when entering new FDA review panels where specialist knowledge is needed.

The 510k Database enriches device records by extracting the correspondent field from FDA accessdata.gov submission pages. When the correspondent (the entity managing the submission) differs from the applicant (the device manufacturer), the correspondent is identified as the regulatory consultant. This data is available for 11,050 records in the dataset.

Identifying the regulatory consultant behind a 510(k) submission reveals which firms specialize in specific device categories, which consultants have the strongest clearance track records in particular FDA panels, and which consulting firms are most active in emerging areas like AI/SaMD. This information supports vendor selection and competitive benchmarking for regulatory affairs teams.