Medical Device

Ensure your medical device attracts customers, not the FDA

If you’re developing, manufacturing, or marketing a medical device, you’ll need detailed knowledge of the FDA regulatory process. Everything from the way your device is classified to to how your product is cleared is complex — and oftentimes confusing for business owners.

In order to be sure you have the right paperwork in place — and have provided FDA personnel with the right information — it’s best to work with a regulatory expert who understands the legislation and can help you navigate it.

At FDA Atty, we work with medical device clients all over the world, providing services in a number of areas:

Device classification: Is your medical device Class I, Class II, or Class III — or is it in more than one Class? You’ll need to know so you can plan and prepare your pre-market submission and regulatory paperwork. We offer product development counseling and assistance with determining product classifications.

Product clearance: Depending on your product class, you may need to file a 510(k) or other pre-market application for your device. We help you with any application, in addition to coordinating with investigators, research firms, manufacturers, and third-party reviewers to conduct necessary testing and analysis.

Label review: In addition to ensuring you have the right content on your labels, we ensure it’s formatted according to FDA regulations. If your device requires specific instructions in the manual, like a hearing aid, for example, we help you figure out the right language to use.

Export certificate: Do you need to use Form 3616a or 3613b? What kind of export paperwork do you need? It’s overwhelming to figure out, but FDA Atty can help. We make sure the right paperwork is filed so that the export process is smooth and worry-free.

Advertising review: When it comes to advertising your medical device, you not only have to follow FDA regulations, you also have to abide by the FTC’s guidelines. We ensure your website, packaging, point-of-sale, and other promotional materials comply with both agencies’ guidelines.

Off-label promotion: There are cases where your business can share medical and scientific information that discusses unapproved uses of the medical device. We offer regulatory counseling so you can develop policy and procedures around this type of content. We also help you train your marketing staff on the procedures.

Adverse event reporting and record keeping: If you’ve received any complaints of malfunctions, serious injuries, or deaths related to your medical device, you’re obligated to report it to the FDA. With our services, you can develop standard operating procedures so you can easily identify and report these adverse events.

Warning Letter and border detention assistance: You may be panicking if you received a Warning Letter from the FDA or if your products are held up at the border. Don’t worry — we can help, but you have to act fast. There are cases where you’re able to fix the products so you don’t have to destroy them. We help you respond and take action right away.

Have peace of mind knowing your medical device business is in good hands. Click the button below to speak with an expert in FDA regulations today.

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