Pilot Builds: Separating Engineering Learning From Saleable Product

What a pilot build is — and why use, not tooling, defines it

Consider a familiar scenario encountered by medical device engineering and commercial teams: your operations team just completed a run of 200 finished units on hard production tooling. The assembly took place in the certified ISO Class 7 cleanroom, the operators followed draft work instructions, and the units are physically indistinguishable from commercial product. Design verification is nearing completion, and line shakeout went smoothly. Seeing pallets of pristine devices in staging, sales leadership immediately asks to ship 40 units to an eager hospital evaluation site and invoice two of them to establish early commercial traction. Which of these units may lawfully leave the facility, under what controls and records, and what regulatory milestones must be reached before any remaining inventory can be sold?

The regulatory answer is that a pilot build's status is set by what each unit is authorized to be used for, not by how it was built. Units fabricated for engineering learning, including bench testing, design verification and validation, simulated-use human factors, packaging integrity, and process validation, stay inside the quality management system as design-and-development evidence. Since February 2, 2026, FDA enforces finished-device CGMP through the Quality Management System Regulation (QMSR, 21 CFR Part 820), which incorporates ISO 13485:2016 by reference. Clause 7.3 applies to the manufacturers named in 21 CFR 820.10(c): class II and class III devices, class I devices automated with computer software, and the class I devices listed in table 1 to 820.10(c)(2). For those devices, pilot units belong in the design and development file required by ISO 13485 Clause 7.3.10. Part 820 no longer uses the name design history file. Comment 31 removed that regulatory term because Clause 7.3.10 already requires a design and development file. An internal label does not meet the clause by itself. These units are not commercial product. Under 21 CFR 807.3(b), commercial distribution is a distribution of a device intended for human use that is held or offered for sale. An engineering build is not that distribution, and describing it as a customer demonstration does not create an exception.

A pilot unit that leaves for a clinical investigation subject to 21 CFR Part 812 is an investigational device. Significant-risk investigations need an FDA-approved investigational device exemption. Nonsignificant-risk investigations follow the abbreviated requirements in 21 CFR 812.2(b) and do not begin with a full IDE application unless FDA tells the sponsor otherwise. A study of a legally marketed device, used within its labeling, can fall outside those IDE requirements. An uncleared pilot unit used on people generally cannot. For an investigational device, 21 CFR 812.5(a) requires the device or its immediate package to bear the statement CAUTION—Investigational device. Limited by Federal (or United States) law to investigational use. Section 812.7 applies to a sponsor, an investigator, or a person acting for either of them. They may not promote or test market the device until FDA has approved it for commercial distribution. The regulation uses the word approved. It does not turn a 510(k) device into a PMA device: FDA's 510(k) page states that marketing waits on an order finding substantial equivalence, while a PMA device waits on an approval order. Section 812.7(b) also prohibits commercializing the device by charging subjects or investigators more than necessary to recover the costs of manufacture, research, development, and handling. A commercial-price invoice to an evaluation site is not that recovery.

A pilot lot becomes commercial finished goods only when the gates that apply to that device are closed. Where 21 CFR 820.10(c) applies, design and development transfer has to be complete under ISO 13485 Clause 7.3.8, as incorporated through the QMSR. Processes whose results cannot be verified by subsequent monitoring or measurement have to be validated under ISO 13485 Clause 7.5.6. The establishment must be registered, and a device placed into commercial distribution must be listed under 21 CFR Part 807. Where 21 CFR 807.81 requires a 510(k), the notification is due at least 90 days before commercial introduction, and FDA states that the device may not be marketed until FDA issues an order finding substantial equivalence. A PMA needs an approval order under section 515 of the FD&C Act. A De Novo petition under section 513(f)(2) is a classification route for a novel device of low to moderate risk, not a high-risk approval. A documented exemption is the premarket record when the device is exempt. Only units released against the current medical device file, with production records for the batch, are finished commercial devices. Built on production tooling is a manufacturing fact, not a marketing authorization. Which of these gates binds a given unit depends on classification, pathway, and the facts of the shipment. The sequence below is a decision framework, not a determination for a specific product.

Sections 501 and 502 of the FD&C Act are the adulteration and misbranding provisions that make the disposition matter. The practical control is to keep three lanes separate, and to move a unit from one lane to another only when its authorization changes:

• Lane 1: Internal engineering evidence. Units built for non-clinical testing, analytical verification, simulated-use usability work that does not put an uncleared device into patient care, bioburden profiling, and manufacturing shakeout. Keep them out of human use and out of any offer for sale. Non-clinical display is a separate control, covered with evaluation units below. It is not permission to leave a functional unit where a hospital can use it on patients.

• Lane 2: Investigational clinical shipment. Units for a clinical investigation subject to Part 812. Significant-risk studies need an approved IDE. Nonsignificant-risk studies follow 21 CFR 812.2(b). Investigational labeling under 21 CFR 812.5 and the charging limit in 21 CFR 812.7(b) apply. IRB review and informed consent follow Part 812 and Parts 50 and 56 where those rules apply.

• Lane 3: Commercial saleable product. Finished devices released against the current medical device file after the applicable gates: design and development transfer where Clause 7.3 applies, validation of processes that cannot be fully verified, establishment registration and device listing, the premarket authorization or documented exemption, and batch production records.

The configuration-to-claim-to-evidence map

Pilot builds get into trouble when a sales or marketing statement outruns the evidence in the design and development file and the medical device file. Assign each unit a build configuration before materials are released to the floor. That assignment is an internal control, not a form FDA prescribes. It is what makes the permitted claim, the recipient, and the record set traceable later.

The matrix below maps each build configuration to the claim it can support, the records that make that claim defensible, and the boundary that actually binds. Not every cell is a statute. Consensus standards and company methods are marked as such.

To visually conceptualize the progression from raw pilot assembly to final disposition, review the regulatory decision lanes below:

flowchart TD
    A["Pilot run"] --> B{"Authorized disposition"}
    B -->|"Engineering evidence"| C["Lane 1: stays in the QMS"]
    C --> C1["Verification, usability, or process evidence"]
    C1 --> C4["Design and development file"]
    C4 --> C5["Retain, convert against the released file, or destroy"]
    B -->|"Clinical investigation"| D["Lane 2: Part 812 when it applies"]
    D --> D1["IDE or abbreviated IDE, as applicable"]
    D1 --> D2["812.5 label and 812.7 limits"]
    D2 --> D4["Site accountability"]
    B -->|"Commercial stock"| E["Lane 3: only after the gates that apply"]
    E --> E1{"Applicable gates closed?"}
    E1 -->|"No"| E2["Do not ship. A missing required authorization can adulterate or misbrand the device"]
    E1 -->|"Yes"| E3["Transfer where Clause 7.3 applies"]
    E3 --> E4["Validate processes that cannot be fully verified"]
    E4 --> E5["Register, list, and close the premarket pathway or exemption"]
    E5 --> E6["Release against the medical device file and batch record"]

The same unit should not change lanes by relabeling. Units used to execute a design verification test protocol are design-and-development evidence. They can support the design and development file. They do not become customer-evaluation product. Invoicing them, or placing them for patient use, is a different disposition and needs the Part 812 or commercial gates that apply. The design-controls guide on this site covers the activity list. Under the QMSR that activity sits in Clause 7.3. Current Part 820 does not state it as section 820.30.

When validation on pilot units is acceptable evidence

A central use of a pilot build is validation evidence. For devices in the scope of 21 CFR 820.10(c), incorporated ISO 13485 Clause 7.3.7 requires design and development validation on representative product, and a recorded rationale for the units chosen. FDA's QMSR design-and-development materials state that this validation needs to be conducted on representative product. Representative product includes initial production units, batches, or their equivalents. Uncontrolled prototypes built on temporary laboratory tooling are not representative merely because they met a bench check. The former 21 CFR 820.30(g) wording is no longer a section of Part 820. Do not cite it as if that section still exists.

The March 11, 1997 Design Control Guidance described the same idea in quality-system-regulation language: validation on initial production units, lots, or batches, or their equivalents, with pilot production simulating actual manufacturing conditions as closely as possible. FDA withdrew that guidance effective February 2, 2026, the day the QMSR took effect. The withdrawn document does not state FDA's current guidance. The current requirement is incorporated Clause 7.3.7. State why these units are representative, including whether they are initial production units, batches, or equivalents, and record the differences that matter. A cassette that works when a senior engineer builds it by hand can fail when the commercial process welds, dispenses, or fixturing changes the geometry. The rationale has to confront that difference rather than assert equivalence.

The QMSR dropped the regulatory headings design controls and design validation. FDA's final rule treats the ISO 13485 requirements, taken together, as substantially similar to the former quality system regulation, and it did not keep a separate definition of design validation. Clause 7.3 is where design and development now sits for devices in the scope of 820.10(c). Clause 7.3.7 is the validation clause. Use it for the representative-product requirement. Use the 1997 guidance only as history of how FDA once explained the same idea.

When pilot units support design validation, the design and development file needs the recorded rationale Clause 7.3.7 requires. There is no FDA form by the name equivalence and representativeness rationale. Address the differences that could make the pilot unit unrepresentative of the commercial device. The questions below are the usual contents of that rationale when they apply to the device. They are not a statutory checklist for every product, and ISO 14644, ISO 14698, ISO 11135, and ISO 11137 apply only if the manufacturer uses those standards or a regulatory requirement points to them.

1. Tooling and equipment. State whether the molds, dies, fixtures, and assembly equipment match the commercial process in the features that affect the device. Where they differ, record why the difference does not defeat representativeness, or do not use the units for validation.

2. Environment. Where the finished device depends on a controlled environment, record the conditions actually used and compare them with the conditions the commercial process specifies. A cleanroom class is relevant for devices that specify one. It is not a universal pilot-build requirement.

3. Instructions and people. Record whether the people who built the units followed the work instructions intended for production, or a draft under change control, and why that still represents production. Informal engineering direction belongs in the rationale as a difference, not as a hidden assumption.

4. Sterilization and packaging, when the device is supplied sterile. Record whether the sterile barrier and the cycle are the validated commercial process. A different cycle, or an unvalidated cycle, is a difference the rationale has to resolve before the units can represent finished sterile product.

5. Materials. Record whether components came from the suppliers and specifications the commercial device will use. For a combination product, include the drug constituent. A development lot from an unqualified source is a difference, not automatic proof of representativeness.

FDA's QMSR page states that devices manufactured under an investigational device exemption are not exempt from the design and development requirements in 21 CFR 820.10(c) and from ISO 13485 Design and Development, which that page describes as Clause 7 and its subclauses. Section 820.10(c) itself requires Clause 7.3 for the devices it lists. A CDRH educational deck from the quality system regulation era said design controls begin after feasibility, once the decision is made to bring the device to market, and before an IDE. Treat that deck as historical education about timing, not as a rule that every missing preliminary test is a specified violation. The binding point is narrower: if Clause 7.3 applies, clinical and validation builds sit inside design and development, not outside the quality management system.

The gate list that makes a pilot lot saleable

Passing final inspection, and later receiving a 510(k) clearance, does not by itself release units that were built before the medical device file existed or that lack production records against that file. Those are different questions, and an inspection can ask both. The five gates below are the decision sequence for the scenario in this article. Two are conditional. Process validation applies to processes that cannot be fully verified. The premarket gate is the pathway that applies, including a documented exemption. The sequence is not a finding that every medical device needs a 90-day 510(k).

Gate 1: Closure of Design and Development Transfer (ISO 13485 Clause 7.3.8)

Where design and development applies, ISO 13485 Clause 7.3.8 requires documented transfer to manufacturing so that design outputs are suitable for production and production can meet product requirements. Transfer is the point at which current specifications are in the medical device file under Clause 4.2.3. In the QMSR final rule, FDA's response to comment 31 states that the agency did not retain separate requirements for the device master record, design history file, or device history record, because Clause 4.2 and its subclauses, and Clause 7 and its subclauses, already require that content (89 FR 7496, February 2, 2024). The design-transfer guide covers the handoff in operational detail. A unit built before the medical device file is released is not commercial stock on the strength of the pilot record. Commercial release requires evidence that the unit conforms to the released file. That comparison is the conversion route discussed with leftover units. Transfer does not work backward by itself.

Gate 2: Process Validation Completion (ISO 13485 Clause 7.5.6)

ISO 13485 Clause 7.5.6 requires validation when the result of a process cannot be fully verified by subsequent monitoring or measurement. Sterile-barrier sealing, welding, and terminal sterilization are typical cases. Fully inspectable assembly steps are not. The clause does not use the labels IQ, OQ, and PQ. Those qualifications are a common way to organize the evidence, and the process validation guide describes them. They are a method, not a separate statute. Units run outside the final validated parameters, including units built to challenge a failing limit, are not conforming product. Units run inside the final validated window can conform and still are not saleable until the other applicable gates and the batch record are complete. Capability indices are analysis tools. Clause 7.5.6 does not require them.

Gate 3: Establishment Registration and Device Listing (21 CFR Part 807)

21 CFR 807.20 requires an owner or operator engaged in manufacturing a device intended for human use, unless section 510(g) of the FD&C Act or Part 807 Subpart D exempts that establishment, to register and to submit listing information for devices in commercial distribution. Under 21 CFR 807.3(b), commercial distribution means a distribution of a device intended for human use that is held or offered for sale. The definition excludes internal transfers and a distribution of a device that has an approved investigational-use exemption under section 520(g) and Part 812. That shipment does not, by itself, put the device into commercial distribution or create a listing duty for it. A nonsignificant-risk investigation that meets 21 CFR 812.2(b) is considered to have an approved IDE application unless FDA notifies the sponsor otherwise, so the same exclusion can cover it. Offering the units for sale does. Introducing a device into commercial distribution without a required registration or listing misbrands it under section 502(o) of the FD&C Act. A pilot lot that is not held or offered for sale is not, by that fact, a listed device. Manufacturing those units also does not erase a registration duty when the establishment is otherwise engaged in manufacturing devices intended for human use.

Gate 4: Premarket Order, De Novo, or a Documented Exemption

21 CFR 807.81(a) requires a person who must register to submit a 510(k) at least 90 days before commercial introduction of a device that meets the criteria in that section, including a first commercial introduction and specified significant changes. Paragraph (b) states when a 510(k) is not required, including while a PMA or a section 513(f)(2) De Novo petition is pending. Section 807.81 is a submission clock. It is not a clearance letter, and it is not a PMA approval. FDA's 510(k) page states that, before marketing, the submitter must receive an order finding the device substantially equivalent, and that the submitter may not market the device until that order. A class III device that requires a PMA may not be commercially distributed without an approval order. A De Novo order classifies a novel low-to-moderate-risk device. It is not a high-risk approval under section 515. A device that is 510(k)-exempt documents the exemption, including the limitations of exemption in the classification regulation, instead of a clearance letter. Shipping a device that requires a 510(k) before FDA issues the substantial-equivalence order skips this gate. If that order arrives before day 90, FDA's 510(k) page states that the device may be marketed when the order is received. The 90 days in 807.81 are the submission lead time, not an additional wait after clearance.

Gate 5: Released Labeling, UDI Where Required, and Batch Release

Commercial labeling has to match the authorization the device actually holds. A unique device identifier in plain text and automatic identification form is required when 21 CFR 801.20 and Part 830 apply. Section 801.30 excepts specified devices, including certain class I devices that are exempt from the CGMP requirements of Part 820, so a rule that every finished device carries a UDI is broader than the regulation. Production records are required by ISO 13485 Clause 7.5.1. FDA's QMSR preamble maps much of the former device history record to those batch records. Clause 8.2.6 requires documented release against acceptance criteria before product is released. A batch without that record stays in quarantine. Environmental and sterilization entries belong in the record when the device specification requires them, not as a checklist for every non-sterile product. 21 CFR 820.35 adds specified complaint, servicing, and UDI traceability records on top of the incorporated standard.

To maintain clarity across executive and operations teams, regulatory affairs must distinguish between legal mandates, voluntary quality badges, and dangerous commercial assumptions. The table below delineates these critical categories:

Evaluation units, loans, and the friendly-customer gray zone

Commercial teams often want key hospitals to see a device before it is authorized: a loan under an evaluation agreement, a nominal demonstration fee, or free consignment for clinical feedback. Those arrangements are not a recognized third status between engineering evidence and either Part 812 or commercial distribution. Whether one of them violates the FD&C Act depends on the facts. An offer for sale is commercial distribution under 21 CFR 807.3(b). Patient use of an unauthorized device is a different problem from a display that never places the device into use.

Section 807.3(b) defines commercial distribution as any distribution of a device intended for human use which is held or offered for sale, and it excludes internal transfers and a distribution under an approved investigational device exemption. It does not exclude evaluation agreements, beta loans, or customer-development placements. A no-charge loan is not, by that definition alone, commercial distribution, because nothing is held or offered for sale. It can still be introduction of an adulterated device if an uncleared or unapproved device is placed for human use. In warning letters about marketing without authorization, FDA pairs adulteration under FD&C Act section 501(f)(1)(B), for the absence of a required PMA or IDE, with misbranding under section 502(o), which covers a missed registration, a missed listing, or a 510(k) notice that was required and not provided. A no-charge loan is not automatically both. The sale question and the patient-use question have to be answered separately.

If the shipment is actually a Part 812 investigation, 21 CFR 812.7 applies:

• Promotion and test marketing, 21 CFR 812.7(a). A sponsor, investigator, or person acting for either of them shall not promote or test market an investigational device until after FDA has approved the device for commercial distribution. The regulation says approved. For a 510(k) device, the commercial authorization FDA describes on its 510(k) page is the substantial-equivalence order.

• Charges, 21 CFR 812.7(b). The same persons shall not commercialize an investigational device by charging subjects or investigators more than necessary to recover the costs of manufacture, research, development, and handling. The section does not prescribe a spreadsheet inside the IDE. The sponsor still needs a cost basis that stays inside that limit. A commercial price is outside it.

• Safety and effectiveness statements, 21 CFR 812.7(d). They shall not represent that an investigational device is safe or effective for the purposes for which it is being investigated. Promotional claims of safety or effectiveness fall under this paragraph and under the promotion ban in 812.7(a). A price sheet is evidence of commercialization or test marketing. It is not, by itself, a representation that the device is safe or effective.

The European line is Article 5 of Regulation (EU) 2017/745. A device may be placed on the market or put into service only if it complies with the Regulation, and it must meet the applicable general safety and performance requirements of Annex I for its intended purpose. Article 2(27) excludes an investigational device from making available on the market, Article 2(28) excludes it from placing on the market, and Article 2(29) excludes it from putting into service. Those units are not outside the Regulation. Article 62 requires clinical investigations to be designed, authorised, conducted, recorded, and reported under Articles 62 to 80 and Annex XV. Some investigations need prior authorization and some follow a notification route. Informal hospital use of a pilot device is not a compliant clinical investigation, and it is not a lawful placing on the market either. This article does not map Annex XV or member-state procedures.

Display is a narrower question than shipment for use. FDA Compliance Policy Guide Sec. 300.600 says that, while a 510(k) is pending, a firm may advertise or display the device, and may not take orders, or be prepared to take orders, that could result in a contract of sale, unless the order is limited to research or investigational use. An order limited to investigational use still has to meet Part 812 if people are the subjects. The guide does not require a specific three-line label, and it does not require every demonstration unit to be destroyed or disabled. A practical control is to keep a functional unit from being left where hospital staff can put it into patient care, and to mark it so that status is obvious to the people handling it. Wording such as not for clinical use is a control the manufacturer chooses. It is not a statutory legend. The same display does not authorize an offer for sale.

Records that survive the audit — and what to do with leftover units

On an inspection under Compliance Program 7382.850, or on an ISO 13485 audit, a pilot build raises a direct question: did units leave without the authorization and the record that their disposition required? FDA's response to comment 31 in the QMSR final rule eliminated the names design history file, device master record, and device history record because ISO 13485 Clause 4.2 and its subclauses, and Clause 7 and its subclauses, already require the content. The regulation does not preserve those names as current terms. The three record sets below use the clause names. An internal title does not replace the clause.

• Design and development file, ISO 13485 Clause 7.3.10. Many firms still label this file a design history file. Clause 7.3.10 requires it to contain or reference the records needed to show that design and development met the design and development plan and the applicable requirements. Pilot protocols, verification results, human-factors reports, and the representativeness rationale belong here when Clause 7.3 applies.

• Medical device file, ISO 13485 Clause 4.2.3. This is the current specification file. The former device master record name covered the same kind of content: manufacturing, packaging, labeling, testing, and servicing specifications that are current for production. Pilot units built before this file is released are governed by the engineering build record, not by a file that does not exist yet.

• Batch and release records, ISO 13485 Clauses 7.5.1 and 8.2.6. These are the production history of a lot, including traceability, inspection, and the release decision. The former device history record is the legacy name. 21 CFR 820.35 adds UDI traceability where that section applies. A commercial shipment needs this record. An engineering unit needs the design and development record instead, not a pretend commercial release.

A major compliance vulnerability arises at the conclusion of pilot activities: what do you do with leftover pilot units? Suppose a 200-unit pilot run consumed 50 units for design verification, 20 units for packaging and shipping validation, and 30 units for destructive biocompatibility and electrical safety testing. You now have 100 fully assembled, functional devices sitting in storage bins. What is their lawful disposition?

Three dispositions cover the usual leftover lot. A return to a supplier, a complaint, or a field action can need a different record. These three fit a completed pilot build that is not already in commercial distribution.

1. Pathway A: Permanent Controlled Retention as R&D Assets. Residual units may be formally segregated, tagged with high-visibility physical labels ('NON-CLINICAL R&D USE ONLY — DO NOT USE IN HUMANS'), and transferred to an isolated engineering crib. These units provide immense technical value as golden reference units for software regression testing, destructive test samples for component end-of-life evaluations, packaging transit shake tests, and operator training models. In the enterprise resource planning or warehouse system, flag these serial numbers so they cannot be picked for a customer shipment.

2. Pathway B: Release against the medical device file, only with a record that the units conform. Leftover pilot units can become commercial inventory only if they meet the released medical device file and the other gates that apply. Where the build differs from that file, ISO 13485 Clause 8.3 treats the gap as nonconforming product, and rework has to bring the unit into specification under a validated instruction when the process requires validation. The GMP manufacturing guide covers production controls. An engineering change order is a common document-control method. Clause 8.3 does not require that document title. If the units were sterilized on an unvalidated cycle, or stored outside the conditions the specification requires, the file does not show that they conform. Conversion then depends on a new validated process and on evidence that the earlier cycle and storage left the units inside specification. When that evidence does not exist, the units stay on Pathway A or Pathway C.

3. Pathway C: Controlled destruction. Units that are not needed for engineering work, and that will not be brought into conformance, can be destroyed under the nonconformity procedure. Destruction has to make the device unusable. A quality record of the serial numbers, date, and method, filed with the batch reconciliation, is the defensible evidence. Part 820 does not prescribe a form titled certificate of destruction.

By establishing clear operational boundaries before the first pilot part is molded, medical device manufacturers protect their clinical stakeholders, safeguard their corporate reputation, and ensure that when commercial scale-up arrives, their regulatory foundation is unassailable.

Sources

The regulatory frameworks, statutory obligations, and quality standards cited throughout this guidance are derived directly from primary regulatory authorities and recognized consensus standards:

• U.S. Food and Drug Administration (eCFR): 21 CFR Part 820 — Quality Management System Regulation, establishing CGMP requirements incorporating ISO 13485:2016 by reference, effective February 2, 2026.

• U.S. Food and Drug Administration: Quality Management System Regulation (QMSR) Overview, clarifying statutory precedence, design and development applicability, and transition enforcement.

• U.S. Food and Drug Administration: QMSR Frequently Asked Questions, confirming that FDA does not require or issue ISO 13485 conformance certificates and outlining Compliance Program 7382.850 inspectional approaches.

• U.S. Food and Drug Administration (CDRH): QMSR Design and Development Educational Materials, detailing the harmonization of design controls with ISO 13485 Clause 7.3.

• U.S. Food and Drug Administration (CDRH): Design Controls presentation (Joe Tartal), a quality-system-regulation-era educational deck on the timing of design controls after feasibility and before an IDE. It is not the QMSR text.

• U.S. Food and Drug Administration: Withdrawn or expired guidance, listing the March 11, 1997 Design Control Guidance for Medical Device Manufacturers as withdrawn effective February 2, 2026. The historical document is not current FDA thinking. The historical copy is identified on the HHS guidance portal.

• U.S. Food and Drug Administration (eCFR): 21 CFR 812.5 — Labeling of Investigational Devices, which states the investigational-device label text and the other labeling content that section requires.

• U.S. Food and Drug Administration (eCFR): 21 CFR 812.7 — Prohibition of Promotion and Other Practices, restricting promotion, test marketing, and limiting cost recovery.

• U.S. Food and Drug Administration (eCFR): 21 CFR 807.3 — Definitions, defining commercial distribution as devices held or offered for sale, excluding approved IDEs.

• U.S. Food and Drug Administration (eCFR): 21 CFR 807.20 — Establishment Registration and Device Listing, establishing registration duties for commercial distribution.

• U.S. Food and Drug Administration (eCFR): 21 CFR 807.81 — Premarket Notification Timing, establishing the 90-day premarket submission clock.

• International Organization for Standardization: ISO 13485:2016 Medical Devices — Quality Management Systems, specifying QMS requirements for regulatory purposes.

• European Union (EUR-Lex): Regulation (EU) 2017/745 on Medical Devices (MDR), defining rules for placing on the market, putting into service (Article 5), and clinical investigations (Article 62).

• U.S. Food and Drug Administration (eCFR): 21 CFR 812.2, including abbreviated requirements for a nonsignificant-risk device investigation.

• U.S. Food and Drug Administration: Premarket Notification 510(k). Before marketing a device that requires a 510(k), the submitter must receive an order finding the device substantially equivalent.

• U.S. Food and Drug Administration: CPG Sec. 300.600, Commercial Distribution with Regard to Premarket Notification. While a 510(k) is pending, a firm may advertise or display the device and may not take orders that could result in a contract of sale, except orders limited to research or investigational use.

• Federal Register: Medical Devices; Quality System Regulation Amendments, 89 FR 7496. FDA's response to comment 31 explains why the QMSR does not retain the device master record, design history file, and device history record as regulatory terms.

• U.S. Food and Drug Administration (eCFR): 21 CFR 801.20, requiring a unique device identifier on device labels when the section applies.

• U.S. Food and Drug Administration (eCFR): 21 CFR 801.30, excepting specified devices from the UDI label requirement, including certain class I devices exempt from Part 820 CGMP requirements.