FDA 510k Consulting

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)
73 Anesthesiology Part 868
74 Cardiovascular Part 870
75 Chemistry Part 862
76 Dental Part 872
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
81 Hematology Part 864
82 Immunology Part 866
83 Microbiology Part 866
84 Neurology Part 882
85 Obstetrical and Gynecological Part 884
86 Ophthalmic Part 886
87 Orthopedic Part 888
88 Pathology Part 864
89 Physical Medicine Part 890
90 Radiology Part 892
91 Toxicology Part 862

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)

We can help you save weeks, months or years of your time to develop and bring your device products into the US market.

Other Services

Late Updated: 2016-01-04