U.S. / FDA Medical Device Market-Entry Product Evidence Pack
From US$1,800 · 3–5 business days after scope confirmation · all prices in U.S. dollars (USD)
Before you enter the U.S. medical device market, get a source-backed view of your product family and how it compares with similar products already in the market.
TrueMedDevice prepares a structured Market-Entry Product Evidence Pack for medical device founders, manufacturers, RA/QA teams, and consultants before formal FDA submission planning. We organize public evidence around direct and indirect similar-product comparison, candidate product-code / regulation / class / pathway clues, FDA forms / fees / eSTAR / guidance / recognized standards, a practical preparation gap checklist, public safety-history themes, and a source ledger.
This is not regulatory, legal, or compliance advice. TrueMedDevice does not determine FDA classification, submission pathway, predicate status, substantial equivalence, compliance, safety, or effectiveness. We prepare a source-backed evidence pack from public FDA sources so qualified RA/QA professionals or regulatory consultants can review and decide.
Who this is for
- Medical device startups and founders at pre-submission stage
- Foreign manufacturers preparing U.S. market entry
- Early RA/QA teams building their first product-family knowledge base
- Regulatory consultants who need a source-backed first scan before scoping an engagement
- Product and engineering teams planning design, risk, and verification strategy before formal submission work begins
This service is designed for teams working on product family scoping before formal FDA submission planning begins — not for teams who have already filed or who need live regulatory advice.
What you get
A structured Market-Entry Product Evidence Pack organized in twelve modules, delivered as a PDF report with source ledger, similar-product comparison, preparation gap checklist, and consultant briefing sheet.
FDA-style product regulatory-language profile
Step 1: Build the regulator-language product-family profile.
Intended use, user / patient / environment, device description, indications, and technology characteristics written in FDA regulatory language. This is the evidence anchor for every subsequent module.
Candidate product code / regulation / class / pathway clues
Candidate FDA product codes, regulation numbers, class clues, and candidate 510(k), De Novo, PMA, 510(k)-exempt, or Pre-Submission discussion points drawn from publicly available FDA records. For qualified RA/QA or consultant review — not a regulatory determination.
Direct and indirect similar-product comparison
Direct and indirect similar products from FDA public data — 510(k), De Novo, PMA, FDA registration — enriched with public company websites, product pages, IFUs, manuals, brochures, labels, and publicly available technical materials where available.
Same / different comparison vs. your product
What appears similar to your product, what appears different, and publicly visible technical-characteristic differences where available. Limitations stated explicitly where public information is incomplete.
Official FDA forms / fees / eSTAR / guidance / standards checklist
Current FDA user-fee references, applicable eSTAR or submission-template references, relevant FDA guidance documents, recognized consensus standards, and a submission-preparation reference checklist. Verified from public FDA sources at pack delivery date.
Practical preparation gap checklist
Information, testing, documentation, labeling, software, risk, usability, biocompatibility, sterility, electrical safety, cybersecurity, clinical, or performance evidence categories to discuss or prepare. Plus public FDA review-timeline references where available.
Public safety-history scan
Recalls, MAUDE themes, warning letters, FDA safety communications, and enforcement / field-action themes for similar product families. Public records only, in the last 3–5 years where relevant.
Candidate review-point library: design / risk / verification / usability / labeling / cybersecurity / PMS
Candidate review questions drawn from the safety-history scan for early design, risk management, verification & validation, usability engineering, labeling, cybersecurity, and PMS planning. For qualified review only — not compliance conclusions.
Source ledger
Record IDs, source links, access dates, and a short note on why each source matters — so any reviewer can re-walk the evidence trail. Transparent and auditable.
Consultant / RA/QA briefing sheet
A structured summary of the pack's findings, formatted for handoff to a qualified RA/QA professional or regulatory consultant.
Clear limitations and unanswered questions
A short, explicit list of what was not in scope, where public information was incomplete, and questions to bring to qualified RA/QA or consultant review.
Reusable Product Evidence Base seed
The pack also becomes the starting point for a source-backed Product Evidence Base around your product family — reused later for consultant discussions, PMS planning, complaint review, risk-file updates, labeling changes, CAPA screening, supplier signals, and inspection-readiness discussions.
Optional: follow-up Product Family Workspace and monthly public safety signal refresh available after initial pack delivery.
International manufacturers
Research packs are prepared with English as the canonical source-backed language. Companion versions in Simplified Chinese or Japanese can be requested to help internal review teams read the evidence more easily. No machine-translated content is delivered without human review.
Pilot pricing
Founder-led pilot pricing — scope confirmed after a short scoping call.
First pilots are founder-led so we can understand the product context before preparing the pack. Final price and delivery timeline are confirmed after a 15–20 minute scoping call. All prices are in U.S. dollars (USD).
- U.S. / FDA Market-Entry Product Evidence Packfrom US$1,800
3–5 business days after scope confirmation
- Canada / Health Canada Market-Entry Product Evidence Packfrom US$1,500
3–5 business days after scope confirmation
- Ongoing Product Evidence Base support
Cadence and scope discussed during the scoping call.
Pilot pricing after first pack
We are currently accepting a small number of founder-led pilot customers. The goal is to understand your product context, deliver a useful first Market-Entry Product Evidence Pack, and learn whether ongoing source-backed Product Evidence Base support would help your team.
Standard scope. Standard pricing covers one product family, one jurisdiction, and one primary intended-use direction, based on non-confidential product information and public sources. Complex multi-product families, multiple intended-use directions, software-heavy products, IVDs, combination-product questions, or expanded competitor / technical comparisons are scoped separately.
Scoping calls are short and used to confirm scope, price, and delivery timeline. No payment is collected before the scoping call.
Also planning Canadian market entry?
See the Canada / Health Canada Market-Entry Product Evidence PackReady to build your U.S. Market-Entry Product Evidence Pack?
Share a non-confidential product description. We will help you structure the first product-family profile and confirm scope, price, and delivery timeline on a 15–20 minute scoping call before the full pack is prepared.
TrueMedDevice does not determine final classification, pathway, licence eligibility, substantial equivalence, safety, effectiveness, compliance, approval likelihood, or regulatory outcome. We prepare source-backed evidence, source ledgers, candidate review points, and briefing materials to support qualified RA/QA, consultant, and company review. Evidence organized. Judgment stays with RA/QA.
What should I research before a U.S. FDA market-entry or 510(k) consultant conversation?
Before the first paid FDA consultant call, organize the public evidence around your product family so the conversation goes to judgment, not retrieval. The U.S. / FDA Market-Entry Product Evidence Pack covers each of the areas below as a source-cited artifact for qualified RA/QA or consultant review.
- Product regulatory identity research
- Product code / classification clues
- 510(k) records and candidate similar devices
- Public device descriptions
- Intended use / indications / technology comparison
- Official forms / fees / guidance checklist
- Recalls, MAUDE, warning letters, safety communications
- Candidate QMS / risk / PMS / labeling / usability review points
- Consultant-prep questions
Every output above is a candidate review point for qualified RA/QA or consultant review — never a regulatory determination. TrueMedDevice does not determine FDA classification, submission pathway, predicate status, substantial equivalence, compliance, safety, or effectiveness.
Background research before scoping
Two open-access research guides covering the work the pack does and the workflow a founder, manufacturer, RA/QA reviewer, or consultant typically runs before formal U.S. submission planning begins.
- U.S. Market-Entry Research Guide — what to prepare before consulting an RA/QA specialist
- FDA 510(k) Similar-Device Research Workflow — how to surface candidate predicate clues from public FDA sources
- Medical Device Safety-History Scan Before Market Entry — public-source review-point playbook
- Prepare for Your First Regulatory Consultant Meeting — eight-block checklist
Frequently asked questions
What is a predicate device?
A predicate device is a U.S. medical device that has already been cleared by FDA via the 510(k) pathway, and that a manufacturer cites in a new 510(k) submission to argue that their device is similar enough to be cleared on the same basis. Predicate selection is the manufacturer's strategic decision, made with RA/QA and consultant input. The Product Evidence Pack surfaces candidate predicate devices from public FDA data — it does not select the predicate for you and does not determine substantial equivalence.
What's the difference between FDA-cleared and FDA-approved?
"FDA-cleared" refers to devices that have been authorized via the 510(k) pathway based on substantial equivalence to a predicate device. "FDA-approved" is reserved for Class III devices authorized via the Premarket Approval (PMA) pathway. Most marketed medical devices are cleared, not approved. Using "FDA-approved" to describe a 510(k) device is a factual error.
Do I need a U.S. agent if I'm a foreign manufacturer?
FDA requires every foreign establishment that imports or offers for import medical devices into the U.S. to designate a U.S. agent. The U.S. agent is the formal communication channel between FDA and the foreign establishment for routine and emergency communications. U.S. agent selection is the manufacturer's decision. The Product Evidence Pack does not select an agent or determine eligibility — it surfaces the obligation context from public FDA sources for RA/QA or consultant review.
How do I search the FDA 510(k) database?
The FDA 510(k) database is at accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm. You can search by applicant, device name, 510(k) number, product code, decision date, and other fields. The openFDA API also provides programmatic access. Our FDA 510(k) similar-device research workflow insight walks the search step-by-step, including reading 510(k) Summaries and Decision Summaries.
What evidence should I bring to a regulatory consultant?
Before a paid consultant call, gather: (1) a written intended-use statement, (2) candidate FDA product-code clues with sources, (3) candidate submission-pathway clues with rationale, (4) a candidate predicate shortlist with K-numbers, (5) a safety-history scan of similar devices (MAUDE, recalls, warning letters), and (6) a forms / fees / typical review-timeline reference. The Product Evidence Pack delivers each of these as a source-cited artifact. Classification, pathway, predicate selection, and submission strategy decisions remain with your RA/QA team or qualified consultant.
This is not regulatory, legal, or compliance advice. TrueMedDevice does not determine FDA classification, submission pathway, predicate status, substantial equivalence, compliance, safety, or effectiveness. We prepare a source-backed evidence pack from public FDA sources so qualified RA/QA professionals or regulatory consultants can review and decide.