510(k) Consulting Services
As FDA 510(k) consultants, we provides a complete package of 510(k) consulting services to global medical device industry. Our 510(k) consulting services include general medical devices including in vitro diagnostic medical devices (IVDs) and 510(k)s for biologics.
Our 510(k) service packages include, but are not limited to, from concept phase to bringing your medical device products to the US market including post-market requirements, to the extent, applicable to your device types.
We employ a CAC-SI* strategic method for our 510(k) services on a case by case basis as applicable regulatory requirements widely vary depending upon device types.
- *CAC-SI refers to “Current, Accurate, and Complete in a Systematic, Integrated”
In the US, most medical devices can be classified by finding the matching description of the device in Title 21 of the Code of Federal Regulations (CFR), Parts 862-892. FDA has classified and described over 1,700 distinct types of devices and organized them in the CFR into 16 medical specialty “panels” such as Cardiovascular devices or Ear, Nose, and Throat devices. These panels are found in Parts 862 through 892 in the CFR. For each of the devices classified by the FDA the CFR gives a general description including the intended use, the class to which the device belongs (i.e., Class I, II, or III), and information about marketing requirements. Your device should meet the definition in a classification regulation contained in 21 CFR 862-892.
|Medical Specialty||Regulation Citation (21 CFR)|
|77||Ear, Nose, and Throat||Part 874|
|78||Gastroenterology and Urology||Part 876|
|79||General and Plastic Surgery||Part 878|
|80||General Hospital||Part 880|
|85||Obstetrical and Gynecological||Part 884|
|89||Physical Medicine||Part 890|
We categorize our 510(k) consulting services into three options as described below. Our client may elect to choose one or more options of our services on a needed basis.
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Option One: Our Services for Medical Device Concept, Design and Development
- Starting from concept phase
- Feasibility studies
- Developing intended use/indications for use
- Pre-submission (Q-submission)
- Device design
- Development plan and planning
Option Two: Our Services for Design Control and Device Testing
- Design verification and/or validation
- Risk management
- Documentation requirements
- FDA-recognized and non-recognized standards (voluntary)
- Establishing quality management systems (21 CFR Part 820 and ISO 13485)
- Applicable performance test plan
- Device performance studies (animal, bench and clinical)
Option Three: Our Services for Regulatory Process (Preparation and Submission for FDA Review)
- FDA laws and regulations applicable
- Intended use/indications for use
- Device panel determination
- Device classification determination
- 510(k) and GMP exemptions applicable
- Identifying suitable predicates
- Substantial equivalence determination
- 510(k) preparation and submission compliant with FDA’s eCopy Program and refuse to accept policy for 510(k)s
- De novo process, if suitable
- Priority review request, if eligible
- 510(k) submission to FDA or thirty party 510(k) program
- Post-market requirements
We can help you save weeks, months or years of your time to develop and bring your device products into the US market.
- Who is required to submit a 510(k)?
- Medical device safety consulting for 510(k) and PMA devices
- FDA 510(k) templates available here
Late Updated: 2016-01-04