Any person, organization or a similar entity that wants to market a class I, II and III medical device intended for human use in the US is required to submit a 510(k) to FDA, provided PMA regulations do not apply to the device. A 510(k) submission is a pre-market submission made to FDA to demonstrate that the device to be marketed is at least as safe as effective as a legally marketed device covered under 21 CFR 807.92(a) (3). I have seen project teams, sales professionals and even quality teams asking similar type of questions on 510(k) submission. I have top 10 of the questions and tried to answer in a way that can be understood easily –
1. To which agency a 510(k) should be submitted?
Ans – A 510(k) submission should be made to Centre for Devices and Radiological Health ( CDRH). However, CDRH has implemented a program that provides an option to submit the 510(k) to recognized third parties approved by FDA.
2. Are contract manufacturers required to submit a 510(k)?
Ans – No. Contact manufacturers who are manufacturing devices under contract to somebody else specifications are not required to submit a 510(k). However, it’s the responsibility of the specification developer to submit a 510(k)
3. My device is already in market. I have discovered a new usage of my device, but not change any device specifications of the device. Is 510(k) applicable?
Ans – Yes. Any major change or modification in the intended use of the device warrants a fresh 510(k) submission process.
4. Does my device need to be exactly similar to the predicate device to prove substantial equivalence(SE)?
Ans – Absolutely not! Equivalence is established in terms of intended use, design, materials used, performance, safety, labelling and other characteristics. The basic purpose of establishing SE is to ascertain that the new device to be introduced is at least as safe and effective as a commercially available device.
5. My firm supplies components to medical devices companies? Am I required to submit a 510(k)?
Ans – There are two things. First, if the supplied component is just getting used for assembling of devices, 510(k) is not required. However, if the components are intended to be used as spare/replacement parts by end users of the medical devices, a 510(k) submission is required.
6. I am a repackager or relabeler of a medical device? Does 510(k) submission apply to me?
Ans –As long as repackaging or relabeling does not significantly change the labelling or intended use of the device, 510 (k) is not required. Otherwise yes.
7. FDA says that 510(k) submission must be made at least 90 days prior to offering the device for sale. Is 90 days calendar days or working days?
Ans – This question sounds funny, but actually this is asked. 90 days refer to working days. However, the actual process takes lot more time and 1-2 year is not uncommon.
8. What are grandfathered devices?
Ans – Devices that were legally marketed in US before May 28, 1976 and since then they have not been significantly modified or for which a regulation requiring a PMA application has not been published are known as grandfathered devices.
9. My firm has submitted a 510(k) for one of the newly developed devices. Will my facilities be inspected by FDA?
Ans – No, FDA does not do a pre-approval inspection for a 510(k) submission. However, once 510(k) is granted, FDA can visit the facility anytime.
10. What documents are asked during a FDA inspection post 510(k) approval?
Ans – Most common are the design control documentation. Also, FDA expects that any changes in the design specifications or manufacturing processes should be in accordance with 21 CFR 820.
The author is a medical device business professional. This article is first in a series of articles where the author has tried to clarify some of the regulatory complexities that shrouds the medical device industry.
