Medical device market entry checklist

Everything downstream is decided by what you claim the product does. Lock the intended use before you spend money on testing or market work.

• Write a one-sentence intended use statement

  Write a one-sentence intended use statement

  Name the condition, the patient population, the clinical setting and the user. This single sentence drives classification, pathway, labeling and reimbursement.

• Inventory every claim you make in marketing, labeling and app stores

  Inventory every claim you make in marketing, labeling and app stores

  FDA reads claims wherever they appear. One condition-specific phrase in a store listing can move a wellness product into device territory.

• Screen against the general wellness and software exclusions

  Screen against the general wellness and software exclusions

  General wellness, administrative software, and pure data display or storage sit outside the device definition. Confirm which side you are on before assuming a pathway.

  Run the classification quiz
• Draft a plain-language risk summary

  Draft a plain-language risk summary

  List what happens if the device fails or gives a wrong output. Risk level is the intuition behind class I, II and III, and it frames every later conversation with a reviewer.

  Read the screening guide

Tie the device to a product code and regulation number. That link tells you the class, the controls and the expected submission type.

• Find the closest FDA product code

  Find the closest FDA product code

  The three-letter code is the key you search by for predicates, registration and listing. Similar-sounding devices can sit under codes with very different burdens.

  Search FDA product codes
• Record the regulation number and device class

  Record the regulation number and device class

  The 21 CFR section defines the device type and any special controls you must meet. Class I, II or III sets the baseline expectation for premarket work.

  How product codes work
• Note the medical specialty panel and any special controls

  Note the medical specialty panel and any special controls

  Special controls are often a guidance document or recognized standard that spells out the exact testing FDA expects.

• Check whether the category is exempt from premarket notification

  Check whether the category is exempt from premarket notification

  Many class I and some class II categories are exempt, with limitations. An exemption you miss is months of unnecessary work.

• Write down the two or three runner-up codes you rejected and why

  Write down the two or three runner-up codes you rejected and why

  Classification is a judgment call. A short written rationale is what you present if FDA or an investor questions the choice.

Exempt, 510(k), De Novo or PMA. The predicate landscape usually points to one route, and the cost difference between them is the biggest variable in your plan.

• Search the 510(k) database for cleared predicates under your code

  Search the 510(k) database for cleared predicates under your code

  Predicates show what indications, testing and labeling FDA has already accepted — and who your direct competitors are.

  Search the 510(k) database
• Read three to five 510(k) summaries in full

  Read three to five 510(k) summaries in full

  The summary describes the evidence that convinced FDA. It is the cheapest possible preview of your own testing plan.

  How to read a clearance record
• Select the pathway and write the justification

  Select the pathway and write the justification

  No predicate and moderate risk usually points to De Novo; high risk with no predicate points to PMA. State the reasoning, not just the conclusion.

  Compare the pathways
• List the bench, biocompatibility, electrical, software and cybersecurity testing required

  List the bench, biocompatibility, electrical, software and cybersecurity testing required

  Testing dominates the timeline. Mapping it against recognized standards early is what makes a schedule credible.

• Decide whether clinical data is needed and of what type

  Decide whether clinical data is needed and of what type

  Most 510(k)s do not need a clinical study; De Novo and PMA usually do. Getting this wrong changes cost by an order of magnitude.

• Plan the quality system and labeling work

  Plan the quality system and labeling work

  Design controls, risk management and a compliant labeling set are expected at submission, not afterwards.

• Consider a Q-Submission to confirm the plan with FDA

  Consider a Q-Submission to confirm the plan with FDA

  A pre-submission meeting is free and converts your assumptions about classification, predicate and testing into written FDA feedback.

Clearance is not revenue. Score candidate countries before you commit a commercial budget, then sequence a first market, a fast-follow and a pilot site.

• Shortlist five to ten candidate countries

  Shortlist five to ten candidate countries

  A shortlist forces trade-offs into the open instead of defaulting to whichever market someone on the team knows best.

  How to pick the best market
• Compare regulatory burden and timeline per market

  Compare regulatory burden and timeline per market

  EU MDR, UKCA and national registrations differ sharply in cost and duration. Timeline differences reorder a shortlist on their own.

• Map the coding, coverage and payment route in each market

  Map the coding, coverage and payment route in each market

  If nobody pays for the procedure your device sits inside, clearance produces no revenue. Coding and coverage are the real gate.

  Market entry strategy guide
• Assess clinical ecosystem and adoption capacity

  Assess clinical ecosystem and adoption capacity

  Reference sites, key opinion leaders and installed infrastructure decide how fast a cleared device actually gets used.

• Check manufacturing, supply chain and distribution factors

  Check manufacturing, supply chain and distribution factors

  Local content rules, tariffs, sterilization capacity and distributor structures can outweigh headline market size.

• Score, rank and sequence: first market, fast follow, pilot site

  Score, rank and sequence: first market, fast follow, pilot site

  A ranked, weighted sequence is the deliverable an investor or board can act on — a list of countries is not.

  Score markets with MedTechCompass

Name what is still unsupported. An honest gap list with owners is more persuasive than a plan that pretends there are none.

• Flag any claim with no cleared predicate behind it

  Flag any claim with no cleared predicate behind it

  An indication broader than every available predicate is the most common cause of a Not Substantially Equivalent decision.

• Flag markets where coverage or payment is unclear

  Flag markets where coverage or payment is unclear

  Unclear reimbursement should downgrade a market's rank rather than be quietly assumed away.

• Flag markets that expect local clinical or health technology assessment data

  Flag markets that expect local clinical or health technology assessment data

  Several payers discount foreign trial data. Finding that out after launch costs a year.

• Flag standards and guidance you have cited but not yet verified against current versions

  Flag standards and guidance you have cited but not yet verified against current versions

  Recognized-standard lists change. Citing a superseded version invites a deficiency letter.

• Attach a primary source and date to every material assumption

  Attach a primary source and date to every material assumption

  Regulator, payer and statute pages are the only citations that survive scrutiny. Undated claims decay silently.

• Assign an owner and a review date to each open gap

  Assign an owner and a review date to each open gap

  A gap without a name and a date is not a plan. This list becomes your standing decision-gate agenda.