Most medical devices in the US today are marketed under the premarket notification 510(k) authorities of the U.S. Federal Food, Drug, and Cosmetic Act. In order to market some types of Class I and most types of Class II devices in the United States, you need to submit a 510(k) submission to FDA and receive FDA clearance.

FDA 510(k) applicants should ensure that their submissions meet RTA screening criteria to avoid RTA letters that can delay their US market commercialization plans. Just have a look on the below five key reasons provided to avoid the RTA letter:

𝙁𝙞𝙫𝙚 𝙠𝙚𝙮 𝙧𝙚𝙖𝙨𝙤𝙣𝙨 𝙛𝙤𝙧 𝙧𝙚𝙘𝙚𝙞𝙫𝙞𝙣𝙜 𝙖𝙣 𝙁𝘿𝘼 𝙍𝙏𝘼 𝙡𝙚𝙩𝙩𝙚𝙧
1. Failure to comply with FDA guidance: Applicants should adhere to recommendations listed in the agency’s guidance documents on formatting Traditional, Special and Abbreviated 510(k) submissions. Some device sponsors may not understand how to compile and format their 510(k) submissions.
2. Failure to supply an eCopy: FDA 510(k) applicants must submit an electronic (eCopy) of their 510(k) applications to the agency.
3. Failure to understand the difference between different types of 510(k)s: There are three types of premarket notification submissions: Traditional (most common), Special (less common) and Abbreviated (rare). Some applicants do not understand the differences between these types of 510(k)s and submit the wrong type.
4. Failure to identify FDA guidance applicable to your device: In their submissions, 510(k) applicants should identify FDA guidance documents if applicable to their devices’ specific product code. If such information has not been included in a submission, FDA reviewers will deem your submission lacking.
5. Failure to provide test data applicable to your device: Virtually all 510(k) applications submitted for FDA review must include some type of test data (e.g., electromagnetic compatibility (EMC), electrical safety, sterilization, biocompatibility, shelf-life, mechanical performance, etc.)

source: https://www.linkedin.com/groups/78665/78665-6389260161084592129