For FDA approval, a Turkish manufacturer usually needs 510(k) clearance, which FDA decides on your evidence rather than your CE marking, and many devices need no 510(k) at all. Your EU MDR technical file is a strong starting point, but every device still needs FDA establishment registration, device listing and a US Agent before import.
Key takeaways
- FDA cleared 28 510(k)s from Turkish applicants from January 2023 to September 2026. That is more than Poland, Portugal, Hungary or Czechia.
- Turkey's Medical Device Regulation follows the EU MDR, so Turkish devices carry CE marking. FDA does not accept CE marking in place of a 510(k), but much of the evidence behind it can carry over.
- Of 77 Turkish sites registered with FDA as device manufacturers, 30 list only Class I devices with no 510(k). Many devices are exempt, but some Class I and textile devices are not.
- Turkish Traditional 510(k)s took a median of 186 days from receipt to clearance, against 151 days for all applicants, with a very wide range. Only 18% cleared within 90 days.
- The FY2027 510(k) fee is $28,653, or $7,163 for a small business. A Turkish company qualifies with a certification from its national tax authority.
How many Turkish devices does FDA clear, and which kinds?
We counted every 510(k) that FDA cleared from January 3, 2023 to September 27, 2026, using FDA's public 510(k) data [1]. Applicants in Turkey received 28 clearances. That ranked Turkey 27th by country, behind Austria and Finland (36 each) and ahead of Thailand (18). It is more than several EU countries: Poland had 9, Portugal 8, Hungary 7 and Czechia 3 [1].
The 28 clearances went to 23 companies, mostly in Istanbul and Ankara. The yearly count was steady: 7 in 2023, 9 in 2024, 5 in 2025 and 7 to the end of September 2026 [1].
Turkish clearances are spread across many fields [1]:
| FDA review panel | Turkish clearances |
|---|---|
| General hospital | 8 |
| Orthopedic | 7 |
| Dental | 4 |
| Anesthesiology | 2 |
| General and plastic surgery | 2 |
| Gastroenterology and urology | 2 |
| All others | 3 |
No device type had more than two Turkish clearances. The repeat types were continuous measurement thermometers, IV fluid transfer sets, surgical gowns, pedicle screw systems and bone plates [1].
Our method: we counted cleared decisions where the applicant's address is in Turkey. The applicant is usually the manufacturer. A Turkish company that files through a US subsidiary is counted under the US.
Does CE marking under the EU MDR help with FDA clearance?
Turkey's Medical Device Regulation, published in the Official Gazette on June 2, 2021, follows the EU Medical Device Regulation (2017/745). It also mirrors the EU's transition dates. Devices with valid certificates under the old directive can stay on the market until December 31, 2027 or December 31, 2028, depending on risk class, if they meet the conditions [9].
FDA does not accept CE marking in place of a 510(k). The 510(k) rules apply to every company that must register with FDA, wherever it is [4]. FDA makes its own decision on your evidence. But an EU MDR technical file is one of the best starting points a manufacturer can have:
- Test reports. FDA accepts reports from Turkish and European labs if they meet its expectations, such as testing to the FDA-recognized version of each standard. The section on test reports below covers this.
- Quality system and risk management. A working ISO 13485 quality system and an ISO 14971 risk file are a strong base for FDA's quality rules. Our QMSR guide explains what FDA expects.
- Clinical data, if you need it. Most 510(k)s include no clinical data. Our analysis of when a 510(k) needs clinical data shows how often they do. FDA can accept data from a clinical study outside the US if it followed good clinical practice and you provide the required supporting information [4].
- MDSAP audits. Any manufacturer can be audited under the Medical Device Single Audit Program. FDA may accept an MDSAP audit report in place of a routine FDA inspection [8].
What does not carry over is your comparison device. Your EU file may compare your device with an equivalent device. A 510(k) must compare your device to a predicate that is legally marketed in the US [4]. A device sold only in Europe or Turkey cannot be your predicate.
Keep your CE marking. The two systems serve different markets, and you can plan both files from the same evidence. For the details, see our guides to what transfers from a CE mark to a 510(k), using CE clinical data for a 510(k) and deciding between FDA first and CE first.
Does every Turkish device need a 510(k)?
No. Each device type has a classification regulation, and it says whether a 510(k) is needed. Most Class I types and some Class II types are exempt [11].
FDA's registration data shows how often this applies. On October 13, 2026, 92 Turkish sites were registered with FDA. Of the 77 registered as device manufacturers, 30 (39%) list only Class I devices with no 510(k) or PMA number [2]. Among the devices Turkish sites list without a 510(k) are adhesive tapes and bandages, incontinence garments, knee braces, medical support stockings and external gauze [2]. All of these types are exempt, including support stockings, which are Class II [11].
Turkey's textile makers should check gowns carefully. Non-surgical gowns are Class I and exempt. Surgical gowns and surgical isolation gowns are Class II and need a 510(k) [11]. The intended use on your label decides which one you make.
Two more cautions:
- Class I does not always mean exempt. Surgeon's gloves and patient examination gloves are Class I, and they still need a 510(k) [11].
- Exemptions have limits. An exempt device still needs a 510(k) if, for example, it has a different intended use or uses a different fundamental scientific technology from other devices of its type. Each classification part sets out these limits, such as 21 CFR 880.9 for hospital devices [4].
Exempt devices still need establishment registration, device listing and a US Agent before they are imported [4]. Contract manufacturers must register and list too, even when another company owns the design [4]. Turkey had 23 sites registered as contract manufacturers and 7 as contract sterilizers [2].
Check your device's product code in FDA's classification database before you plan a 510(k) [11]. Our device classification guide explains how to read an entry.
What are the steps from Turkey to the US market?
For a device that needs a 510(k), the usual order is:
- Confirm the classification. Find the product code, regulation number and class. Your EU risk class does not convert to an FDA class. If you cannot tell, you can ask FDA through a 513(g) request. Its FY2027 fee is $8,596, or $4,298 for a small business [3].
- Choose a predicate. Pick a device legally marketed in the US with the same intended use. Search FDA's 510(k) database by product code. Our predicate guide explains how.
- Map your EU test reports. Check each report against the FDA-recognized version of its standard, and plan only the tests you are missing.
- Request small business status early. If your company and its affiliates had gross receipts of no more than $100 million, apply at least 60 days before the 510(k) fee is due [3].
- Build the submission in eSTAR. FDA has required eSTAR for 510(k)s since October 1, 2023 [5]. All content must be in English, including translated test reports [6].
- Pay the fee and submit. FDA must receive the correct fee when you submit, or it will not accept the 510(k) [3]. FDA then has 15 calendar days for its acceptance review [6].
- Answer FDA's questions. If FDA sends an Additional Information request, the review goes on hold. You have up to 180 calendar days to send a complete response, or FDA considers the 510(k) withdrawn [7].
- Receive the clearance letter. Your device is cleared, not approved. Approval is the word for PMA devices.
- Register, list and name a US Agent. Do this before the device is imported. The sections below cover timing and cost, and our importing guide covers customs entry.
Your team runs any new testing through labs of your choice. A US Agent and an importer fill the US roles, and you can add a regulatory advisor.
What does FDA clearance cost a Turkish manufacturer?
FDA's fees for fiscal year 2027 apply from October 1, 2026 to September 30, 2027 [3]:
| FDA fee (FY2027) | Standard | Small business |
|---|---|---|
| 510(k) | $28,653 | $7,163 |
| 513(g) request for classification | $8,596 | $4,298 |
| De Novo request | $191,020 | $47,755 |
| Annual establishment registration | $13,785 | $13,785 |
The small business rate cuts the 510(k) fee by three quarters. To get it, a company outside the US sends FDA a MDUFA Small Business Request form and a certification from its national tax authority. For a Turkish company, that is the Revenue Administration (Gelir İdaresi Başkanlığı). The certification must show gross receipts for the most recent tax year in both US dollars and Turkish lira, the exchange rate used and the dates covered. Each affiliate needs its own certification [3].
Small business status lasts one fiscal year. Status for FY2026 ended on September 30, 2026, so you must qualify again for FY2027 [3]. Our small business guide walks through the request.
The annual registration fee has no small business rate. FDA may waive it only for a business with no more than $1 million in gross receipts on its most recent US federal tax return [3].
FDA fees are only part of the budget. The real cost drivers are:
- Testing gaps. The tests your EU file is missing, or tests to a standard version FDA does not recognize.
- Translation. Every report and supporting document must be in English [6].
- Repeat work. A weak response to FDA's questions adds cost and time.
- US roles. You will pay a US Agent, and you may pay an advisor.
Use our FDA user fees page to check the current rates before you budget.
How long does FDA clearance take for Turkish manufacturers?
All 28 Turkish clearances were Traditional 510(k)s. They took a median of 186 days from FDA's receipt to clearance, against 151 days for all applicants. The range was wide: a quarter cleared within 113 days, and a quarter took 404 days or more. Only 18% cleared within 90 days [1].
With so few clearances, yearly medians move a lot. They were 176 days in 2023, 278 in 2024, 132 in 2025 and 115 so far in 2026 [1]. Treat these as a signal, not a forecast. Our review times by country analysis compares Turkey with other countries.
FDA's review goal counts only FDA's own days. Its clock stops while it waits for your answers, and it starts only once FDA accepts the file [7]. So much of a long total is time on hold. That puts the fastest lever in your hands: a complete eSTAR and quick, complete answers to FDA's questions.
Turkish companies have not yet used the faster routes much. There were no Special 510(k)s, which are for changes to your own cleared device, and only one third-party review [1]. Some Turkish device types, such as IV fluid transfer sets and continuous measurement thermometers, are eligible for third-party review [11]. Our third-party review guide explains how it works.
When do you need a US Agent and FDA registration?
Not before your 510(k). You can submit a 510(k) and receive clearance before you register. But no device may be imported into the US unless its maker's site is registered and the device is listed [4].
The rules for a Turkish site [4]:
- Timing. Register within 30 days of starting the operation that requires registration, and list your devices at the same time.
- Fee first. Pay the annual registration fee before you register. A site is not legally registered until it has registered and paid [3].
- One US Agent. Name one US Agent who lives or has a place of business in the US. FDA may contact the agent when it cannot reach you, and the agent helps schedule inspections. Report any change to the agent within 10 business days.
- Every year. Renew registration and review all listings between October 1 and December 31.
- English. Registration and listing information must be in English.
Your EU Authorised Representative does not fill this role. The US Agent is a separate, US-based appointment.
Complizen's US team handles establishment registration, device listing and the US Agent role for foreign manufacturers. Exempt devices, such as bandages or support stockings, can enter the US this way while a 510(k) for another device is still in progress.
Which Turkish test reports does FDA accept?
FDA accepts test reports from Turkish labs. What counts is the standard and version you tested to, the completeness of the report and how the study was run, not where the lab is.
Three points matter most for Turkish manufacturers:
- No ASCA labs in Turkey yet. On October 12, 2026, FDA's ASCA program listed 98 accredited labs, and none were in Turkey [10]. For biocompatibility, an ASCA summary report can replace a complete test report in some cases [12]. Without an ASCA lab, plan to submit complete biocompatibility test reports [12].
- Lab accreditation is not GLP. For biocompatibility, FDA recommends a statement that the studies followed its Good Laboratory Practice rules in 21 CFR Part 58. FDA notes it does not recognize ISO/IEC 17025 accreditation for this purpose [12].
- Harmonized versions. The EU harmonized edition of a standard (EN ISO) may differ from the edition FDA recognizes. Check each one in FDA's Recognized Consensus Standards database.
Our guide to using foreign test reports in a 510(k) covers the full rules.
What do Turkish manufacturers get wrong?
Each of these mistakes breaks a clear FDA rule:
| Common mistake | What FDA actually requires |
|---|---|
| Sending the EU MDR technical file as the 510(k) | A comparison to a US predicate, in the eSTAR format, in English [4, 5, 6] |
| Using an EU equivalent device as the predicate | A predicate legally marketed in the US [4] |
| Assuming all gowns are exempt | A 510(k) for surgical and surgical isolation gowns [11] |
| Expecting the EU Authorised Representative to act for FDA | A separate US Agent named in FDA registration [4] |
| Paying the full 510(k) fee by mistake | A small business request, with a Revenue Administration certification, at least 60 days before the fee is due [3] |
| Treating ISO/IEC 17025 accreditation as GLP | A GLP statement for biocompatibility studies [12] |
| Answering an FDA question late or in part | A complete response within 180 calendar days, or the 510(k) is withdrawn [7] |
What should you do next?
Start with your product code. It tells you whether you need a 510(k), which standards apply and how long similar devices have taken. Then compare your EU MDR technical file with what a 510(k) for that product code needs, test by test. Before you submit, decide who will answer FDA's questions in English, and how fast.
If you want a second view of that comparison, Complizen, which has a team in Turkey, offers a free Gap Assessment that checks your device documents against what a 510(k) needs before you file. For the wider picture of selling in the US from outside it, see our international path.
Frequently asked questions
How does a Turkish manufacturer get FDA approval?
Most devices from Turkey need 510(k) clearance, not approval. You show that your device is substantially equivalent to a predicate legally marketed in the US. Some devices are exempt from a 510(k). Every device also needs FDA establishment registration, device listing and a US Agent before it is imported.
Does CE marking help with FDA clearance?
Not directly. FDA does not accept CE marking in place of a 510(k). But the evidence behind it often helps: test reports to standards FDA recognizes, an ISO 13485 quality system and an ISO 14971 risk file. The main gap is the predicate, which must be a device legally marketed in the US.
Should I drop CE marking to focus on FDA?
No. CE marking and FDA clearance serve different markets, and Turkey's own rules follow the EU MDR. Much of the same evidence supports both files. The better question is which to do first and how to plan both from one set of tests, which depends on your markets and device.
How many Turkish medical devices has FDA cleared?
FDA cleared 28 510(k)s from applicants in Turkey from January 2023 to September 2026, according to our count of FDA's public data. They went to 23 companies, mostly in Istanbul and Ankara. Hospital, orthopedic and dental devices led, and no device type had more than two.
Do surgical gowns need FDA clearance?
Surgical gowns and surgical isolation gowns are Class II devices and need a 510(k). Non-surgical gowns are Class I and exempt from a 510(k). The intended use on your label decides which one you make. Every gown maker still needs FDA registration, listing and a US Agent.
Do I need a US Agent before submitting a 510(k)?
No. You can submit a 510(k) and receive clearance before naming a US Agent. You must register your site, list the device and name a US Agent before the device is imported into the US. Your EU Authorised Representative cannot act as your US Agent unless it also has a US presence.
How much does a 510(k) cost a Turkish company in FY2027?
FDA's 510(k) fee for fiscal year 2027 is $28,653, or $7,163 for a qualifying small business. Annual establishment registration is $13,785. Missing tests, translation, a US Agent and any advisor are separate costs. They depend on how much of your EU file already meets FDA's expectations.
How does a Turkish company qualify as an FDA small business?
Send FDA a MDUFA Small Business Request form and a certification from Turkey's Revenue Administration. It must show gross receipts in US dollars and Turkish lira, with the exchange rate. Affiliates need certifications too. Combined receipts must be no more than $100 million. Apply at least 60 days before the fee is due.
How long does FDA clearance take for Turkish manufacturers?
Turkish 510(k)s cleared from 2023 to September 2026 took a median of 186 days from receipt to clearance, against 151 days for all applicants. The range was wide, from under 113 days for a quarter of them to over 404 days for another quarter. Much of the time is usually hold time.
Can I use my EU test reports for a 510(k)?
Often, yes. FDA accepts reports from labs in Turkey or Europe if they meet its expectations: the FDA-recognized standard version, a complete report and an English translation. EU harmonized editions and FDA-recognized editions can differ. Biocompatibility studies also need a statement on Good Laboratory Practice.
Can I use an EU equivalent device as my predicate?
No. A predicate must be legally marketed in the US. That means a device cleared through a 510(k), marketed before May 28, 1976, or reclassified. An equivalent device under the EU MDR may be the same product, but it only qualifies if it is also legally marketed in the US.
Do Turkish contract manufacturers need to register with FDA?
Yes. A site that makes a device for another company must register with FDA and list the device, even when the other company owns the design. In FDA's data, Turkey had 23 sites registered as contract manufacturers and 7 as contract sterilizers. Each pays the annual registration fee.
References
- openFDA. 510(k) API, decisions dated January 3, 2023 to September 27, 2026. Accessed October 12, 2026.
- openFDA. Registration and Listing API, establishments in Turkey. Accessed October 13, 2026.
- FDA. Medical Device User Fee Rates for Fiscal Year 2027. Federal Register, July 30, 2026.
- eCFR. Title 21: Part 807, Establishment Registration and Device Listing (§§ 807.20, 807.22, 807.40, 807.81, 807.92); § 812.28, Acceptance of clinical data to support medical device applications; § 880.9, Limitations of exemptions. Current as of October 2026.
- FDA. Electronic Submission Template for Medical Device 510(k) Submissions. Final guidance, October 2, 2023.
- FDA. Refuse to Accept Policy for 510(k)s. Final guidance, April 21, 2022.
- FDA. FDA and Industry Actions on Premarket Notification (510(k)) Submissions: Effect on FDA Review Clock and Goals. Final guidance, October 3, 2022.
- FDA. Medical Device Single Audit Program (MDSAP). Content current as of December 19, 2025.
- Türkiye İlaç ve Tıbbi Cihaz Kurumu. Tıbbi Cihaz Yönetmeliğinde Değişiklik Yapılmasına Dair Yönetmelik, amending the Medical Device Regulation of June 2, 2021. Resmî Gazete No. 32151, April 2, 2023.
- FDA. ASCA-Accredited Testing Laboratories database. Accessed October 12, 2026.
- FDA. Product Classification database. Accessed October 13, 2026.
- FDA. Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". Final guidance, September 8, 2023.