FDA · ISO 13485 · QMSR · EU IVDR
Regulatory Affairs, Clinical Affairs, and Quality Assurance services for early-stage and established In Vitro Diagnostic (IVD) and medical device companies — from concept to commercialization.
General regulatory filings & consulting
We offer regulatory consulting and assistance for FDA and IVD compliance. Our team of scientists, biostatisticians, medical writers, project managers, clinical managers, and regulatory strategy experts navigate these pathways daily.
Supported by an in-house team and an integrated CLIA-, GCP-, and GLP-compliant clinical laboratory, data management and regulatory submission become a simplified process for your medical products. From concept to commercialization, or for discrete projects in between, we provide the diagnostic and regulatory support to complete your project promptly.
Regulatory roadmap
Three questions shape your U.S. regulatory strategy: how your device is classified, which premarket pathway that requires, and when to engage FDA.
FDA has classified about 1,700 generic device types across 16 medical specialty panels, each assigned to Class I, II, or III by the level of control needed.
Your class — and whether a suitable predicate exists — determines whether you need a 510(k), a De Novo request, a PMA, or no premarket submission.
A Pre-Submission (Q-Sub) gets FDA feedback before you file. A 513(g) request asks FDA how it would classify and regulate your device.
Each class carries its own controls and submission requirements.
Controls
General Controls
Premarket
Most Class I devices are exempt from 510(k); those that are not exempt require a 510(k).
Controls
General Controls and Special Controls
Premarket
Most require a 510(k) demonstrating substantial equivalence to a legally marketed predicate; some are exempt.
Controls
General Controls and Premarket Approval
Premarket
Premarket Approval (PMA), typically supported by clinical data. Clinical studies of significant-risk devices may require an IDE.
Novel low-to-moderate-risk devices with no legally marketed predicate can request De Novo classification into Class I or II — creating a new device type that later products can use as a predicate.
With FDA’s LDT rule vacated in 2025 and rescinded, tests developed and performed within a single CLIA-certified laboratory are governed by CLIA rather than FDA premarket review. See our Clinical Laboratory Consulting →
Classification and pathway decisions are device-specific. We confirm the current FDA requirements for your product at the start of every engagement. Sources: FDA, Classify Your Medical Device; FDA, Premarket Submissions.
Analytical performance studies
Most 510(k), De Novo, and PMA submissions for IVDs rest on analytical performance data. We design the studies, run them in our CLIA-certified, CAP-accredited laboratory or at your site, and deliver reports ready to go into your submission.
Protocols aligned to CLSI guidelines and FDA guidance, with acceptance criteria, sample sizes, and specimen sourcing — ideally confirmed with FDA in a Pre-Submission.
Studies run under protocol at PacificDx, our CLIA-certified, CAP-accredited laboratory, or by our team at your site — with documented deviations and full data traceability.
Statistical analysis and study reports written in the format reviewers expect, ready to drop into your submission.
The exact set depends on your technology, specimen types, and intended-use claims.
Repeatability, within-laboratory precision, and multi-site reproducibility (CLSI EP05, EP15).
Limit of blank, limit of detection, and limit of quantitation (CLSI EP17).
Linearity and reportable range across the claimed measuring interval (CLSI EP06).
Interference from endogenous and exogenous substances, and cross-reactivity (CLSI EP07, EP37).
Specimen, reagent, and calibrator stability, including shipping and freeze-thaw (CLSI EP25).
Agreement with a predicate or reference method, plus carryover and reference intervals (CLSI EP09, EP28).
CLSI: Clinical and Laboratory Standards Institute. Many CLSI guidelines are FDA-recognized consensus standards.
Need an analytical study plan for your submission?
Start a discussionRegulatory, quality & clinical services
From the first conversation with FDA to the marketing submission and beyond, we develop, write, and review the documents and systems your product needs.
Supported by our integrated CLIA-, GCP-, and GLP-compliant clinical laboratory and in-house scientific, biostatistics, and medical writing teams.
Program support
Reduce short- and long-term costs through a robust nonclinical program, with support in methodology and strategy, study design, development, and accountability for program execution.
Move your product efficiently and successfully through the clinic using a customized clinical design solution.
Maximize the potential of your program throughout development and the commercial lifecycle with strategic insights that position your product for success.
Ways to engage
Bring us in for a single, well-defined project or for end-to-end support from concept to commercialization.
A review of your device, intended use, and existing data to determine classification and the most efficient U.S. pathway.
Pre-Sub package development, meeting preparation, and presentations to get actionable FDA feedback before you file.
Writing, compiling, and reviewing 510(k), De Novo, or PMA submissions, plus IDE and supporting reports.
External compliance and pre-inspection audits against 21 CFR Part 820 (QMSR) and ISO 13485, including QSR-to-QMSR transition gaps, with a prioritized remediation plan.
Technical File, Design Dossier, and design and development file preparation and maintenance, including software documentation and labeling.
Warning Letter responses run on deadlines. Contact us as soon as you receive one so we can help you plan a complete, on-time response.
For over 15 years, we have helped In Vitro Diagnostic and medical device companies achieve their regulatory goals. Tell us where your product is today.