Implant Devices Performance Requirements
Medical devices that are placed inside a surgically or naturally formed cavity of the human body are considered implants by FDA.1 These can be permanent (e.g., knee implant) or temporary (e.g., chemotherapy ports), and are made from a wide variety of materials. As medical devices, the risks associated with implants include surgical risks during placement or removal, infection, reaction to implant materials, and device failure. The degree of risk of each of these varies based on the location (invasiveness) of the implant and the intended use – implants that support vital life functions, for example, have much higher risks associated with device failure. The higher risk the implant device, the higher the evidentiary expectations when submitting a 510(k) for market clearance.
On September 7 2023, FDA released a draft guidance document entitled: “Evidentiary Expectations for 510(k) Implant Devices.” This draft guidance highlights considerations relevant to all types of implants subject to 510(k) requirements, with a focus on implant devices performance requirements.
The FDA has issued guidance documents since 1994 outlining requirements for specific implant types (e.g., hydroxyapatite coated orthopedic implants, penile implants, glaucoma implants, breast implants). Additionally, regulations and product codes for these implants may include specific testing requirements for clearance or approval, detailed in special controls.
Public comments following FDA’s announcement of efforts to modernize the 510(k) pathway for medical devices, in November 2018, specifically highlighted the need for greater transparency in the 510(k) submission process for implants. As a result, on September 7 2023, FDA released a draft guidance document entitled: “Evidentiary Expectations for 510(k) Implant Devices.”2 This draft guidance highlights considerations relevant to all types of implants subject to 510(k) requirements, with a focus on implant devices performance requirements.
The amount and type of performance data needed to demonstrate “substantial equivalence” for an implant varies depending on its specific nature. This draft guidance serves as a foundational resource, intended to be used alongside more specific guidelines and voluntary consensus standards. The document includes multiple references to these additional resources.
The FDA emphasizes three key factors influencing the performance data required for an implant: indications for use, intended duration of implantation, and anticipated patient and physician experience.
- Indications for Use: These define the patient population, disease state, and conditions under which the implant will be used. This information is crucial for designing representative performance testing.
- Duration of Implantation: The required testing will vary depending on how long the implant is intended to last. For example, an implant designed to degrade within 30 days will have different testing requirements than one expected to last for years.
- Patient and Physician Experience: Risk analysis and required testing must consider the impact of the implant on daily activities (e.g., airport scanners) and medical procedures (e.g., MRIs).
This guidance document summarizes recommended non-clinical performance tests for implants, referencing specific guidelines for each test. Manufacturers may justify omitting a test by submitting a rationale explaining its non-applicability.
Recommended Non-Clinical Tests:
- Biocompatibility: This ensures the implant’s compatibility with the body’s tissues.
- Sterility and Shelf Life: These tests assess the implant’s sterility and how long it remains sterile under specific storage conditions.
- Packaging: This test ensures the packaging protects the implant’s sterility and functionality during transport and storage.
- Reprocessing and Cleaning (if applicable): This test verifies the effectiveness of reprocessing methods (for reusable implants) and cleaning procedures.
- Software and Cybersecurity (if applicable): These tests ensure implant software functions as intended and has adequate cybersecurity measures.
- Electrical Safety and Electromagnetic Compatibility: These tests ensure the implant doesn’t pose electrical hazards or malfunction due to electromagnetic interference.
- Magnetic Resonance Compatibility (if applicable): This test determines if the implant is safe for patients undergoing MRI scans.
Additional Considerations:
- Subject-Predicate Device Differences: Additional testing may be necessary depending on the differences between the new implant and the predicate device used for comparison. These tests could assess corrosion, fatigue, degradation, and compatibility with imaging or radiotherapy procedures.
- Animal Testing: While animal studies aim to generate safety data, they can also provide insights into an implant’s effectiveness. For instance, they can be used to assess device migration or the impact of degradable implants on tissue.
- Design Considerations: Information on raw materials, manufacturing processes, and how they impact the final design may be important for understanding substantial equivalence.
- Human Factors/Usability: This test evaluates the ease of use and safety of the implant for both patients and healthcare providers.
FDA notes that while clinical performance testing is not always necessary for establishing substantial equivalence, there are scenarios where it will be required.
The guidance also covers essential information for implant labeling. Instructions for use should address risks for both healthcare providers and patients. These instructions should detail mitigations for risks associated with errors by laypeople after implantation, safety during everyday activities, and safety during medical procedures. Additionally, labeling should include information on device operation, implantation instructions, and implantation removal as applicable. Implant cards should be provided that include identifying information on the specific implant, details on device composition, and how to report malfunctions or adverse events.
To ensure a smooth 510(k) clearance process, medical device companies developing implants should consult this guidance early on. It outlines the implant devices performance requirements and provides a valuable collection of references to more specific resources. These resources, including guidance documents and consensus standards, can inform implant design and 510(k) submission preparation.
About Boston MedTech Advisors (BMTA):
Since 2004, BMTA’s multidisciplinary team of highly experienced consultants has supported more than 400 medical technologies and life sciences companies around the world to achieve their business goals. BMTA assists its clients to commercialize new products and services and increase their market adoption, by addressing their unique and inter-dependent regulatory, clinical, reimbursement, marketing, and business development requirements. BMTA offers valuable, ethical, result-oriented, professional, and cost-effective insights that recognize the multi-faceted aspects of today’s healthcare markets and the client’s unique business needs.
For more information, questions, or comments, contact us at info@bmtadvisors.com
Follow us on LinkedIn.
References:
- Implants and Prosthetics https://www.fda.gov/medical-devices/products-and-medical-procedures/implants-and-prosthetics
- Draft Guidance for Industry and Food and Drug Administration Staff “Evidentiary Expectations for 510(k) Implant Devices” September 2023. https://www.fda.gov/media/171835/download
Photo 68108593 | Implant © Edward Olive | Dreamstime.com
