FDA recently issued new guidance regarding how FDA responds to device classification questions submitted under Section 513(g) of the Federal Food, Drug, and Cosmetic Act. In short, a 513(g) Request for Information must be submitted in writing to FDA, must be for a single device, currently costs approximately $3,500 in (up front) user fees, and may take up to 60 days to process. So what does one get for all that time and money? In responding to 513(g) Requests, FDA will generally answer only the following questions about the requestor’s device:
- What generic type does the device fall within? (non-binding opinion)
- What is the device’s class? (non-binding opinion)
- Is a PMA, 510(k), or neither required in order to market it? (non-binding opinion)
- What other requirements are applicable? (non-binding opinion)
- Has FDA issued a guidance document regarding the exercise of enforcement discretion over the particular class of devices within its generic type? (non-binding opinion)
FDA has made it clear that it does not review data related to substantial equivalence or safety and effectiveness in response to a 513(g) Request. Did we mention that FDA’s opinion is non-binding? Also, FDA does not allow any edits to 513(g) Requests. This means if a manufacturer or distributer changes anything about the device or it’s marketing, it costs another $3,500 and up to 60 additional days before FDA will supply an answer.
Now, compare that with the services of FDAImports.com. For any medical device questions, FDAImports.com gives you far more, for less money, and in a much shorter period of time:
- Unlike FDA, we are not limited to answering only a specific set of simple questions, nor will we charge $3,500 to answer such questions.
- We don’t automatically double our price if you forget to ask a question or need an explanation. Unlike FDA, we only charge you for the work we actually do.
- We don’t stop at medical devices. FDAImports.com is your one-stop shop for all FDA-related matters in all industries such as facility registration and device listing services, importation matter resolution, label reviews, regulatory advice, import alerts, etc…
- We know from experience that actual people work at the FDA; however, if you try to call them you may question our experience. Either way, if you want to talk to a real person then call FDAImports.com
- Finally, if we take anywhere close to 60 days to answer your questions, please fire us!
Don’t waste precious time and money getting expensive, incomplete and non-binding answers from the U.S. Food and Drug Administration. Contact us now and ask us your questions for medical devices or anything else.
Source
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm209841.htm
