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Pre-Market Clearance and Approval

Selecting and preparing the correct premarket submission for your medical device is crucial, saving you time, money, and headaches in the process of getting your product to market. Clearance and approval from the U.S. Food and Drug Administration (FDA) can feel overwhelming. While it can be a timely and complicated process, that’s where Sterling comes in. With our premarket clearance and approval services, we can support your:

  • FDA 513(g) Request for Information Determining the correct classification of a medical device is necessary to choose the appropriate FDA regulatory strategy. It is the responsibility of the manufacturer to determine device classification, but it is not always clear cut. If you are unsure of the appropriate classification, you may submit a 513(g) Request for Information to the FDA. The process requires a detailed device description, which includes indications for use, intended use, a description of its fundamental operating technology, labeling, and comparison to a similar currently marketed device, if applicable.
  • FDA Q-Submission The Q-Submission, or Q-Sub, is a structured process between manufacturers and the FDA for future applications for approval and clearance that occurs before Premarket Notification(510(k)), Investigational Device Exemption (IDE), Premarket Approval (PMA), Humanitarian Device Exemption (HDE), and De Novo request submissions. This is where you establish your strategy, articulate your strategy to the FDA through a series of meetings
    • Agreement meeting
    • Day 100 meeting
    • Determination meeting
    • Informational meeting
    • Pre-submission meeting
    • Study risk determination
     , and compile critical documents for your pre-submission.
    Cover letter that includes the following information
    • Purpose
    • Regulatory History
    • Planned Follow-on Submission
    • Background Information
    • Device Description
    • Proposed Predicate Devices (if applicable)
    • Intended Use/Indications for Use Statement
    • Description of How the Device is Planned to be Used
    • Risk Analysis
    • Discussion of Relevant Prior Information
    • Proposed Study Design
    • Specific Questions
    • Meeting Attendees
    • Proposed Meeting Dates (unless written feedback is requested)
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  • FDA 510(k) Manufacturers of low- to moderate-risk devices that do not qualify for an exemption, but have a predicate device on the market, can submit a 510(k) that proves the device is substantially equivalent to other devices previously cleared by the FDA. Supporting claims that your medical device is substantially equivalent to one or more legally marketed devices requires comprehensive information and documents
    • Medical Device User Fee Cover Sheet (FDA Form 3601)
    • CDRH Premarket Review Cover Sheet (FDA Form 3514)
    • 510(k) Cover Letter
    • Indications for Use (FDA Form 3881)
    • 510(k) Summary
    • Truthful and Accurate Statement
    • Class III Summary and Certification
    • Financial Certification or Disclosure Statement
    • Declaration of Conformity and Summary Reports
    • Executive Summary
    • Device Description
    • Substantial Equivalence Discussion
    • Proposed Labeling
    • Sterilization and Shelf Life
    • Biocompatibility
    • Software
    • Electromagnetic Compatibility and Electrical Safety0
    • Performance Testing – Bench
    • Performance Testing – Animal
    • Performance Testing – Clinical
    • A Truthful and Accurate Statement Format
    • A Certification
    • A Disclosure
    • FDA form 3654
    • Software Certificate
    • Certificate of Clinical Trials Form 3674
    . More specifically, Sterling’s 510(k) services include:
    • Submission documentation compilation and submission
    • Submission documentation gap analysis
    • Submission documentation remediation
    • Exemption support
    • Abbreviated support
    • Special supplement support
    • Letter-to-file support
  • FDA Investigational Device Exemption (IDE) An IDE permits an investigational device to be used in a clinical study in order to collect safety and effectiveness data needed for regulatory submission. Sterling’s services include:
    • Early feasibility study
    • Application
    • Supplement
    • Documentation
      • Name and address of sponsor
      • Report of prior investigations including reports of all prior clinical, animal, and laboratory testing of the device
      • A bibliography of all relevant publications
      • Copies of published and unpublished adverse information
      • Copies of other significant publications if requested
      • A summary of all other relevant unpublished information
      • A statement that any nonclinical laboratory studies have been conducted in compliance with the Good Laboratory Practice (GLP) regulations
      • Investigational plan (§812.25)
      • A description of the methods, facilities, and controls used for the manufacture, processing, packing, storage, and installation of the device
      • An example of the agreement to be signed by the investigators with a list of the names and addresses of all investigators
      • Certification that all investigators have signed the agreement
      • A list of the names, addresses, and chairpersons of all IRBs
      • The name and address of any institution (other than those above) where a part of the investigation may be conducted
      • The amount charged for the device and an explanation of why sale does not constitute commercialization
      • Copies of all labeling for the device
      • Copies of all informed consent forms and all related information materials
      • Any other relevant information requested by the FDA
  • FDA De Novo Petition A De Novo petition requests a marketing pathway to classify novel medical devices that have no legally marketed predicate devices when general controls alone, or general and special controls, provide reasonable assurance of safety and effectiveness for the intended use. A De Novo petition requires an extensive list of elements
    • A coversheet clearly identifying the request
    • Administrative information, such as the device’s intended use, prescription use or over-the-counter use designated, etc.
    • Device description, including technology, proposed conditions of use, accessory, components, etc.
    • The classification as recommended under section 513 of the Federal Food, Drug, and Cosmetic Act
    • A complete discussion of why general controls or general and special controls provide reasonable assurance of the safety and effectiveness of the device
    • Relevant clinical data
    • Non-clinical data including bench performance testing
    • Information on the reprocessing and sterilization, shelf life, biocompatibility, software, electrical safety and electromagnetic compatibility, animal study, literature
    • A description of the probable benefits of the device when compared to the probable or anticipated risks when the device is used as intended
     to be accepted by the FDA.
  • FDA HUD and Humanitarian Device Exemption (HDE) A Humanitarian Use Device (HUD) is one that treats or diagnoses diseases or conditions affecting no more than 8,000 people in the U.S. each year. An HDE is an exemption provided by the FDA that allows the marketing of a medical device without proof of effectiveness.
  • Emergency Use Authorizations (EUA) An EUA allows the FDA to authorize emergency use of medical devices in extenuating circumstances like a public health crisis. Sterling can help prepare the considerable list of documentst
    • A description of the product and its intended use
    • A description of the product’s FDA approval status; whether the product or intended use is under an investigational application; whether the product is approved in a foreign country for either the proposed use or another use; information on the use of the medical product by either a foreign country or an international organization.
    • The need for the product, including identification of any approved alternative product(s) and their availability and adequacy for the proposed use, and the unmet need(s) the EUA would address
    • Available safety and effectiveness information for the product
    • A discussion of risks and benefits
    • Information on chemistry (as applicable), manufacturing, and controls; a list of each site where the product, if authorized, is or would be manufactured, and the current CGMP status of the manufacturing site(s)
    • Information about the quantity of finished product on hand and the surge capabilities of the manufacturing site(s)
    • Information comparable to an FDA-approved package insert or instructions for use
    • If seeking an extension of a product’s labeled expiration date, any available information in support of such an extension
     required to receive this authorization. You can also check out our webinar on COVID-19 Regulatory Assistance for Medical Device EUAs for more information.
  • Premarket Approval (PMA) Class III devices that support or sustain human life require a PMA submission to prove the safety and efficacy of the device.

Sterling can help.

At Sterling Medical Devices, our medical device regulatory compliance consultants take on the burden to help you meet the required regulatory controls that assure your medical device’s safety and effectiveness—throughout the entire product development life cycle. We have a deep understanding of the many ins and outs of the FDA requirements processes, so you can leave all the details to us. We will manage the entire process, start to finish. 

About Sterling Medical Devices 

Sterling Medical Devices specializes in the design, development, and test of medical devices. Sterling addresses every aspect of the development process: software, electronics, mechanical, quality, and compliance. Our goal is to make sure you get the FDA approval and CE Marking you need to bring your device to market. Sterling Medical Devices has developed more than 1,000 medical device products for over 300 companies, ranging from Class II diagnostic and therapeutic systems to Class III implantable devices, using embedded systems, PC based devices, smartphones/tablets, and web/cloud services. We are proud to have worked with such prestigious organizations as Covidien, St. Jude Medical, Medtronic, Boston Scientific, Johnson & Johnson, and many more. We also partner with early-stage companies to help them bring new products to market. In every case, we produce the right product in the right time frame with the right budget.

Resources

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