US FDA Medical
Device Services

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No medical device or IVD manufacturer wants to receive a Form 483 or Warning Letter from the US Food and Drug Administration (FDA). The FDA Form 483 is officially called a “Notice of Inspectional Observations,” commonly referred to simply as a “483.” The 483 is issued at the end of an on-site inspection if the FDA field investigator observed deficiencies in your quality system or conditions that violate the Food, Drug, or Cosmetic Act.

You got a US FDA form 483 – now what?

The field inspector will submit the final 483 to his/her superiors; if the findings are serious enough, or if the response to the 483 that you submit is deemed insufficient, an FDA Warning Letter may be issued to your firm. A Warning Letter is the FDA’s advisory notice that you have significantly violated FDA regulations. It will identify the violation(s), and make it clear that you must correct the problems and inform the FDA of your specific plans for correction of the problem, including actions to prevent it or a similar problem from re-occurring. The FDA will check to determine whether your corrections are adequate.

How to respond to a Form 483 or warning letter

You must respond to the 483 or a Warning Letter promptly and identify your course of action to correct the findings within the FDA’s specified timeframe. A detailed response to each observation or violation noted is also required. The quality and promptness of your response to this letter are extremely important.

Patient Guard can help you respond to an FDA Form 483 or warning letter

Patient Guard can assist you in preparing an effective response to an FDA Form 483 and Warning Letter. We can provide you with direction to bring your quality system into full compliance with the regulations. As part of our services, we will:

  • Analyze the findings of the FDA Form 483 and/or Warning Letter.
  • Suggest an appropriate timeline to satisfy the FDA.
  • Assist your company in charting a course of action.
  • Propose “Corrective Actions” to be made to your quality system.
  • Assist in implementing corrective actions in response to FDA Form 483.
  • Be available to answer all questions from you or the FDA during your efforts to correct the noted deficiencies or violations.

Patient Guard has worked with medical device and IVD companies to formulate proper responses to FDA 483 and Warning Letters.

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If a product satisfies the requirements of Section 201(h) of the Food, Drug, and Cosmetic Act, it is deemed a medical device by the FDA and is regulated by the agency. TSG can assist you in any of the following two ways: (1) figuring out whether your product, or a portion of it, fits the criteria of a medical device; or (2) assessing whether your product fits the definition of a combination product, which consists of a device with at least one medication and/or biologic. We can assist you in preparing a 513(g) request to the FDA’s Centre for Devices and Radiological Health (CDRH) and/or a Request for Designation (or a pre-RFD) to the FDA’s Office of Combination Products (OCP) if it is unclear whether your product is a device or a device-led combination product. This will allow you to receive a definitive response. Furthermore, if you choose to advertise the product on the basis that the FDA is exercising its enforcement discretion and not regulating it as a device, Patient Guard can assist you in documenting in an internal memo-to-file that the product is not a device.

Unless the device is exempt from 510(k) requirements, you will obtain the Agency’s authorisation in order to market an FDA-regulated medical device in the United States. It might be difficult to determine if a product needs FDA premarket evaluation and, if so, what kind of premarket submission is appropriate. TSG can investigate if the FDA has categorised the kind of device as Class I (lowest risk), Class II, Class III, or Class IV (highest risk), as well as the kind of premarket filing that is necessary. Approved PMAs are required for Class III devices. The majority of Class II devices—though not all—need 510(k) approval. Class I and Class II device 510(k) exemptions are subject to certain restrictions, nonetheless.

We can assist you in determining whether your particular device is covered by the 510(k) exemption for a certain type of device. To discuss getting FDA approval to market your device, please email and our regulatory consulting team wil lbe in touch.

FDA guidelines and regulations outline the fundamental requirements for format and content for various submission types. We can assist you in identifying the kinds and quantities of data that the FDA is probably going to need in your device’s premarket submission. Additionally, we may assist you in getting ready to submit a pre-submission to the FDA in order to receive their initial input on whether the planned, ongoing, or completed testing will yield the data required by the Agency in order to assess the device’s safety and effectiveness. To assist make sure the data satisfies FDA criteria, we may also examine and offer feedback on the methods for your device’s performance (bench, animal, and clinical), biocompatibility, and human factors testing. We have a great deal of experience with 510(k)s, the most typical kind of premarket submission, as FDA 510(k) consultants.

The requirements set by the FDA vary based on the level of risk associated with the study. The medical device regulatory team at Patient Guard can assist you in determining whether a proposed clinical study falls into one of three categories: nonsignificant risk (NSR) that is presumed to have an approved IDE; significant risk (SR) device study that requires FDA approval of an investigational devices exemption (IDE) application; or study that is exempt from FDA’s IDE requirements. After that, we can assist you in meeting all relevant IDE criteria. Additionally, we can assist you in meeting FDA regulations pertaining to informed consent, Institutional Review Board (IRB) approval, and disclosure of clinical investigators’ financial interests in the product and/or study sponsor.

We can assist in identifying potential predicate and reference devices, identifying the primary and any secondary predicates, comparing the new device to its predicate(s), analysing test data, creating or assessing the substantial equivalency argument, drafting the 510(k) or reviewing and offering feedback on the company’s draught submission, if the device needs 510(k) clearance. We are also able to review IDEs, HDEs, PMAs, and de novo requests. In addition, if you meet the requirements, we can help you with the procedures for paying the FDA’s standard or small business user fee and applying for small business classification. We can also assist you in responding to the FDA’s requests for further information while the Agency reviews your application and in representing your business at FDA meetings. For additional information on your support needs, please contact

Unless your device is 510(k) exempt, you will need to adhere to at least two additional FDA requirements in order to commercialise it after receiving 510(k) clearance, de novo permission, HDE approval, or PMA approval. It is required that you either update your registration or register as a device establishment, along with paying the initial (year) registration charge. You will also need to update your listing for that kind of gadget or list the new one. You also need to fulfil the premarket requirements mentioned in the clearance letter, such as submitting the final labelling, if your device has PMA or HDE approval. We can assist you in completing these duties.

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