A 510(k) is a regulatory review process intended for moderate risk devices for which a substantially equivalent product is already on the market. A PMA is a regulatory review process intended for high-risk devices.
FDA has 90 days to review and clear/deny a 510(k), however FDA may request additional information around day 45. This request may put FDA's review clock on hold. The submitter is generally given up to 180 additional days to produce the requested information, after which FDA uses the remaining days from the initial 90 to finish their review.
You determine FDA classification by defining your device's Intended Use and Indications for Use. You can then search the FDA Product Classification Database to find a regulation number and product code that matches your device. If no matching classification exists, the device is automatically Class III unless you submit a De Novo request.
A pre-submission meeting is not required. It is a means to engage the agency in early discussions regarding the device.
The STeP program is intended for devices that radically improve the safety of treating/diagnosing/etc a medical condition as compared to current options. It is an expedited process that, ideally, gets the safer technology to market faster than a Traditional 510(k).
Under the new Quality Management System Regulation (QMSR), the FDA has harmonized its requirements with ISO 13485:2016. While the fundamental obligation to maintain thorough, traceable documentation remains, the legacy terminology has shifted:
- Design History File (DHF) → Design and Development File (DDF): The requirement to document a device’s evolution from concept to final design now follows ISO 13485 Clause 7.3.10.
- Device Master Record (DMR) → Medical Device File (MDF): The "manufacturing blueprint" is now consolidated under the Medical Device File (Clause 4.2.3), which centralizes the specifications and procedures needed for production.
- Device History Record (DHR) → Production & Service Records: While the term DHR is no longer explicitly used in the regulation, manufacturers must still provide objective proof that each batch was manufactured and inspected in compliance with the MDF.
At Kapstone, we ensure that your existing legacy files are properly mapped to these new structures, maintaining compliance without disrupting your established workflows.
ISO 13485:2016 is the international gold standard for medical device quality management. Within this framework, Clause 7.3.8 specifically addresses design and development transfer. It requires rigorous verification that design outputs are fully suitable for manufacturing before they are released as final production specifications.
Yes. The QMSR applies to all manufacturers of finished devices intended for the U.S. market, including contract manufacturers. As a single-source partner, Kapstone maintains a QMSR-compliant environment to ensure that every stage of your product’s journey—from design transfer to full-scale production—meets these updated federal requirements.
MDD was a directive requiring transposition into each member state's law; whereas MDR is a regulation - meaning laws that apply to all member states without any transposition.
- The MDR is broader in scope and includes device categories that were previously unregulated, such as re-processed single-use devices.
- MDR re-classified many existing devices into HIGHER classifications - thus requiring more rigorous documentation requirements.
- Expansion of Technical Documentation required, including, but not limited to clinical evidence.
Learn more on our blog: Three Key Differences Between MDD and MDR.
EU MDR allows 'legacy devices' with valid MDD certificates to remain on the market until the transition deadline (2027 or 2028), provided there are no significant changes to the design or intended purpose. However, manufacturers must immediately update their Post-Market Surveillance (PMS) and vigilance reporting to meet stricter MDR standards.
MDR requires a Post Market Surveillance Plan, Periodic Safety Update Report, Post Market Surveillance Report, and integration of these documents and clinical evidence into Risk Management Process.
No, compliance with ISO 13485 alone is not enough to be compliant with the FDA's new Quality Management System Regulation (QMSR). The FDA has retained specific requirements for UDI, labeling, and MDR reporting.
No, certification is not required to start prototyping. However, you must implement specific Design Controls and Risk Management procedures early. Essential procedures include: Design & Development (ISO 13485 Cl. 7.3), Risk Management (ISO 14971), Document Control & Record Retention, and Supplier Selection.
FDA QSR is a U.S. federal regulation, while ISO 13485 is an international quality management standard. QSR is enforced through FDA inspections, while ISO 13485 requires third-party certification and emphasizes risk-based processes and global harmonization.
A regulatory gap analysis identifies any changes to the regulations since the last implemented effort and identifies any non-conformities/deficiencies with the existing documentation.
The cost to commercialize a Class II 510(k) medical device typically ranges from $250,000 to over $1 million. Labor for engineering, regulatory, and quality assurance typically accounts for 50% of the total budget.
Human factors (Usability) is the discipline focused on designing medical devices that are safe and intuitive. It examines user interface design, labels, user populations, and work environments to reduce use errors.
Testing requirements are determined by body contact nature and duration (ISO 10993-1). Contact devices typically require Cytotoxicity, Sensitization, and Irritation testing; implants require more extensive testing.
A single-source partner manages the entire journey from concept to production, eliminating technical and regulatory risks associated with vendor handoffs. This includes NPD, Regulatory Affairs, QA, and Manufacturing.
Design Transfer is the handoff of final design specifications to the manufacturing team. It occurs when the design is 'frozen' and ensures reliable, repeatable manufacturing results.
Yes, Kapstone offers contract manufacturing services for all classes of products, including FDA Class III implants.
