Hi. I was a level II certified international medical device investigator for the FDA for over 21 years. Currently, I am a contract international medical device consultant for hire.
I hope the following helps.
There are 4 areas that companies dealing with US sold medical devices have to address. They are:
1. Registration. This is documentation stating the type of firm- manufacturer, repacker/relabeler, initial importer, etc.
2. Product listing. This is documentation noting the individual devices you manufacture, repack, import, etc.
3. PMA or 510(k) product approval- actually FDA does not approve products, but gives the ok for you to market products, depending upon the classification and labeled intended uses (see below).
4. Adherence to applicable FDA laws and regulations.
However, you first have to figure out whether the medical device products you handle are finished devices (or certain components/accessories to finished devices). (I've detailed this information below.)
If your product is deemed a finished device, then you have to figure out what operations you do onsite. This means- "Are you required to register?"
Next, you have to determine who owns the product. This means- who is responsible for the approval of the product labeling and specifications and the handling of complaints. This means- "Do you have to list and/or submit 510(k)/PMA documentation to the FDA?".
FDA classifies devices depending upon risk- as class I/II/III. If the product is substantially equivalent to a product marketed before May 28, 1976 (i.e. prior to the initial device regulation), then you may have to submit paperwork justifying so (unless the product is a grandfathered product or does not need a 510(k) submittal- usually class I devices). These products are usually class II devices. This is what is known as a 510(k) submission (i.e. 510(k) is the FD&C section that notes substantial equivalence).
If not, then the product is a new device and you have to prove its safety and effectiveness through clinical trials before FDA will allow you to market it in the US. These products are class III devices. This is what is known as a PMA submission.
However, if your marketing materials or website information notes differing claims, then those contained in the 510(k) or PMA labeling, then you now have an adulterated and misbranded medical device.
Depending upon your circumstances, you have to at least register and comply with the applicable FDA laws and regulations.
All medical device manufacturers (including specification developers), repackers/relabelers, initial importers, and foreign manufacturers and exporters have to register plus list their medical products with the FDA.
FDA is interested in two types of medical device products:
a. Finished products.
b. Components/ accessories which are ready to be used for any intended health related purpose and are packaged or labeled for commercial distribution for such health-related purpose.
However, not all registered companies own the products or need approval by FDA to market the product. Thus, not everyone needs to (such as certain contract facilities) or chooses not to (such as certain foreign manufacturers) submit product listings and/or 510(k)/PMA submissions to the FDA. However, this does not mean that these documents do not have to be submitted at all, but that other firms (such as specification developers or initial importers) have to submit the paperwork.
As I already explained, finished product medical device products are either grandfathered, need to show substantial equivalence to products marketed prior to May 28, 1976, or need to show they are safe and effective before FDA will allow the sale of these products in the US.
For the US market, FDA has three types of product classifications. These classifications are based upon risk.
1. Class I (§ 513)
These are low risk medical devices which undergo general controls
(GMP’s).
For example: Crutches, bandages, first aid kits.
2. Class II (§ 514)
These medical devices have insufficient information to be class I devices
and need to undergo additional constraints (i.e. special controls,
performance standards, post market, surveillance, guidelines, patient
registries) besides the general controls (GMP’s).
For example: Burn dressings, daily-wear contact lenses, orthopedic
implants.
3. Class III (§ 515)
These medical devices have insufficient information for special controls
to be class II products, can not be classified into class I or class II
devices and are typically life-sustaining/life supporting products. These
products either need premarket approval or have 510(k) classification.
For example: Extended-wear contact lenses, pacemakers, orthopedic
cement.
As such:
1. Is the product a finished medical device?
2. Is the product a 510(k) product (i.e. substantially equivalent) or a 510(k) exempt product? If not, then the product is a PMA product (i.e. need to show safety and effectiveness)? FDA may change the classification of devices- usually downward from class II to I or III to II.
If there are changes to the product design (which include changes to intended uses and product labeling), these changes have to be evaluated to determine whether a new 510(k) or PMA supplement needs to be submitted to the FDA.
If company "X" owns the product and company "Y" distributes the product, then company "Y" does not need to submit a 510(k) or PMA. However, if company "Y" changes the intended use, design, packaging, labeling (other than re-stickering with company name, address, and telephone), then company "Y" now owns this revised device and needs to submit a 510(k) or PMA. This is why US hospitals who now re-sterilize one time use sterile devices (received from manufacturers or distributors) are now considered manufacturers (reprocessors) and have to register, list, submit 510(k)'s/ PMA's, comply with the QSR, etc.
When in doubt, don't be afraid to contact your local FDA office or CDRH's DSMA.
Also refer to the CDRH site
http://www.fda.gov/cdrh/devadvice/index.html
I know that this is a lengthy reply, but hope it helps you and others.
